Surgery and radiation therapy in the management of craniopharyngiomas

Twenty-nine patients with histologically confirmed craniopharyngioma were treated from 1960 to 1978, inclusive. Twelve patients were below the age of 15 years, the remaining were adults. Seventy-five percent (9/12) of the patients below the age of 15 showed increased intracranial pressure at presentation and 58% (7/12) showed visual disturbances. In the adult group, 47% (8/17) presented with increased intracranial pressure and 88% (15/17) with visual disturbances. Hormonal, mental and behavior changes were almost equally distributed in both age groups. All patients underwent craniotomy, with subtotal resection of the tumor. Three adults died of postoperative complications (10%), of whom two died of pulmonary emboli and one of cerebral hemorrhage. Of the remaining 26 patients, 13 received immediate postoperative radiotherapy to a total dose of 50.0 to 56.0 Gy, in a target volume including the sellar and parasellar region during an overall treatment period of five to six weeks. All patients were evaluable with a minimum follow-up of four years since they finished their treatment or until death. The five-year recurrence-rate in the group that did not receive postoperative radiation therapy was 45% (5/11 patients) and the five-year rate of death of disease in this group was 27% (3/11 patients). For the group that received immediate postoperative radiation therapy the five-year recurrence-rate was 11% (1/9 patients) and no death of disease was observed in this group. This difference between the two groups was not significant. The corresponding 10-year rates were 71% (5/7 patients) for recurrence and 57% (4/7 patients) for death of disease in the group without, and in the group with immediate postoperative radiation therapy the rate was 25% (2/8 patients) for recurrence and 0 for death of disease. This difference turns out to be significant. Critical analysis of the morbidity in patients surviving after treatment showed no adverse effect on the visual or endocrine status of the group that received postoperative irradiation. It is concluded that in the management of patients with craniopharyngiomas, postoperative irradiation after subtotal resection improves the prognosis of the patient and does not add to visual or endocrine morbidity.     

A comparison of the roles of surgery and radiation therapy in the management of carcinoma of the female urethra

Between 1939 and 1986, 42 patients with carcinoma of the female urethra were treated with surgery and/or radiation therapy at the University of Iowa. Ten patients were treated with surgery alone, 28 with radiation therapy alone, and 4 with combined surgery and radiation therapy. Seventeen patients (40%) developed persistent or recurrent disease at the primary site and 15 (36%) had failures in the inguinal nodes. The actuarial 5-year survival rate was 33.5%. Only 36% (10/28) of patients treated with radiation therapy had local failures, compared to 60% (6/10) of those treated with surgery alone. The best results were achieved with combined interstitial and external beam irradiation. Whereas 57% (8/14) of patients who were treated with combined interstitial and external beam irradiation were alive NED at 3 years, none of 7 patients (0%) treated with interstitial implants only and 2 of 7 patients (29%) treated with external beam irradiation alone were alive NED at 3 years. There was a significantly lower inguinal failure rate in patients who received treatment to the inguinal nodes (10%) than in those who did not receive inguinal area treatment (52%), and this translated into a superior 5-year survival for those patients (60% vs 18%). Survival rates did not correlate with histopathologic type in this series, although there were differences in the patterns of failure. Survival rates did correlate well with clinical stage.     

Surgery with or without radiation therapy in the management of craniopharyngiomas in children and young adults

PURPOSE: The optimal management of craniopharyngiomas remains controversial, especially in children and young adults. This study reports a single institution's experience with such patients. METHODS AND MATERIALS: Between 1974 and 2001, 76 patients were treated for craniopharyngioma at the Children's Hospital of Philadelphia and the Hospital of University of Pennsylvania (HUP). Of these, 75 patients (97%) were evaluable with long-term follow-up. Although all patients underwent attempted gross total resection, 27 had documentation of less than total resection with 18 of these patients receiving immediate postoperative radiotherapy (RT). An additional 22 patients received RT at HUP after failing surgery alone. RESULTS: Median follow-up for all patients was 7.6 years. The 10-year actuarial overall survival, relapse-free survival, and local control (LC) rates for all patients were 85%, 48%, and 53%, respectively. When comparing the 57 patients treated with surgery alone to the 18 treated with subtotal resection (STR) followed by RT, a significant difference in LC rates at 10 years (42% vs. 84%, respectively; p = 0.004) was noted. However, no statistically significant difference in overall survival was found between the two groups, because RT was highly effective as salvage therapy. Twenty-two patients at HUP treated with RT after relapse had a 10-year ultimate LC rate comparable to that of patients who received RT immediately after STR. CONCLUSION: RT given either immediately after STR or at relapse is effective in controlling craniopharyngiomas.     

腺癌保乳术后调强放疗与三维适形放疗的疗效比较

目的 比较乳腺癌保乳术后调强放疗(IMRT)与三维适形放疗(3D-CRT)的疗效、不良反应及对基质金属蛋白酶-9(MMP-9)和基质金属蛋白酶组织抑制剂-1(TIMP-1)的影响.方法 选择96例接受乳腺癌保乳术的女性患者,按照随机数字表法将患者随机分为对照组和观察组,每组各48例.对照组予以3D-RCT,观察组予以IMRT,处方剂量均为50 Gy/25次.比较两组的照射剂量、不良反应、美容效果及治疗前后的血清MMP-9和TIMP-1水平.结果 观察组计划靶区(PTV)的V105%、V110%及V115%明显低于对照组(P﹤0.01),观察组患侧肺脏及左侧病灶者心脏接受的照射剂量明显低于对照组(P﹤0.01);观察组的皮肤反应率为12.5%(6/48),低于对照组的29.2%(14/48),差异有统计学意义(P﹤0.05);观察组美容优良率为97.9%(47/48),高于对照组的83.3%(40/48),差异有统计学意义(P﹤0.05).放疗后,两组患者的MMP-9及MMP-9/TIMP-1均较本组治疗前降低,但组间比较差异无统计学意义(P﹥0.05).结论 与3D-CRT相比,IMRT的PTV适形度和剂量均匀性较好,可降低危及器官的受照剂量,皮肤反应较少且美容效果好,值得临床推广.     

Radiation therapy in craniopharyngiomas

Eighteen patients with cranipharyngiomas, who were studied and treated between 1970–1980, are presented. Each patient was treated with surgery and radiotherapy (50–60 Gy). Six patients were treated with radiotherapy because the tumor recurred after surgery. An extensive representation of the clinical symptomatology typical of this tumor was seen. In 3 patients an improvement in visual symptoms was demonstrated; in 11 the headaches and vomiting were controlled after treatment. The 18 treated patients are still alive without evidence of progression of the tumor, after a period of 2 to 12 years. Our experience supports the contention that conservative surgery coupled with radical radiotherapy remains the treatment of choice for the craniopharyngioma.     

Pediatric craniopharyngiomas: long term results of combined treatment with surgery and radiation.

From 1961 to 1981, 19 pediatric patients with craniopharyngiomas were treated with external beam radiation post surgery. Twelve underwent primary treatment while seven were treated for recurrence. Median follow-up is 21 years (range 8-28 years) with an overall 20-year survival of 62%. Twenty-six percent (5/19) developed disease recurrence following radiation. Of the multiple patient and treatment parameters analyzed, only initial disease status (i.e., primary vs recurrence), surgical extent, radiation dose, and treatment prior to routine use of CT scans (1961-1974) appeared to have major influence on patient outcome. The 20-year survival for those treated for primary disease was 78% versus 25% for those treated for recurrence. Fifty percent (3/6) of patients receiving tumor doses of < or = 5400 cGy developed recurrences versus 15% (2/13) in those receiving > 5400 cGy. Four of the five recurrences occurred in patients treated during the pre-CT era. Long term effects of treatment were analyzed. Surgical morbidity correlated strongly with extent of surgery. All patients who underwent total resection developed surgical sequelae. Radiation morbidity correlated strongly with radiation dose. The incidence of vascular or neurologic complications attributable to radiation were minimal, occurring in only two patients. Both received doses higher than that given with modern therapy. Long-term results from this series are better than those reported with surgery alone. Use of modern surgical and radiation equipment/technique along with CT/MRI imaging should yield improved treatment results both in terms of lower recurrence and lower toxicity rates.     

Surgical management of craniopharyngiomas

Surgical treatment of craniopharyngiomas has been historically challenging and, despite advancements in microsurgical and skull base techniques, continues to pose a challenge to modern day surgeons. In particular, proponents of subtotal resection in conjunction with radiotherapy argue that this less aggressive approach can yield equivalent control rates with lower morbidity, while others argue that gross total resection is superior. Regardless of whether gross total or subtotal resection is the goal, surgical planning must include a thorough endocrine and neuro-ophthalmologic evaluation as well as imaging, and the approach, whether transsphenoidal or transcranial, must take into account the nature of the tumor and its location. In addition, optimal management of craniopharyngiomas must consist of an individualized and multidisciplinary approach not only including neurological surgery, but also including endocrinology, neuro-ophthalmology, neuropsychology, and, often, radiation-oncology.     

Update on management of craniopharyngiomas

Journal of Neuro-Oncology - Craniopharyngiomas are locally-aggressive tumors arising along the hypothalamic-pituitary axis. Treatment is nuanced as a result of their proximity and adherence to...     

Pediatric intracranial ependymoma: the roles of surgery,radiation and chemotherapy

Management of pediatric intracranial ependymomas poses a major challenge, and optimal treatment remains controversial. We sought to investigate the roles of surgery, radiation, and chemotherapy in a historical cohort. Thirty-nine children, age 21 or younger, with non-metastatic intracranial ependymomas were treated from 1972 to 2008. Median age was 8 years (range 0.2–19.1). Twenty-one patients (54%) underwent GTRs, and 18 (45%) underwent STRs. Twenty-six patients (67%) received upfront adjuvant RT (67%), and 14 (44%) received adjuvant chemotherapy. Twenty-four patients had disease recurrence and 12 died. Only one patient recurred after 5 years. Median PFS was 2.7 years and median OS was 20 years. Fifteen year PFS and OS were 30 and 67%. Adjuvant RT was associated with improved PFS (P = 0.045), and remained significant after adjusting for EOR (P = 0.04). Greater EOR trended towards prolonged survival, but did not reach statistical significance (P = 0.156). Of the patients that underwent GTR, the median PFS was 38 months for those treated with adjuvant RT versus 30 months for those that were not treated with RT. Of the patients that had STR, the median PFS for those treated with RT was 26.3 months versus 6.9 months for those were not treated with RT. In conclusion, for localized intracranial pediatric ependymomas, adjuvant RT is associated with improved PFS, even after adjusting for EOR. Our findings suggest the benefit of RT even in the presence of GTR. Future prospective studies with larger sample number are needed to validate our findings.     

Emerging roles of radioresistance in prostate cancer metastasis and radiation therapy

Radiation therapy (RT) continues to be one of the most popular treatment options for localized prostate cancer (CaP). Local CaP recurrence after RT is a pattern of treatment failure attributable to radioresistance of cancer cells. One major obstacle to RT is that there is a limit to the amount of radiation that can be safely delivered to the target organ. Recent results indicate that phosphoinositide 3-kinase (PI3K)/Akt/phosphatase and tensin homolog (PTEN)/mammalian target of rapamycin (mTOR) signaling pathway, autophagy, epithelial–mesenchymal transition (EMT) and cancer stem cells (CSCs) are involved in CaP metastasis and radioresistance. Emerging evidence also suggests that combining a radiosensitizer with RT increases the efficacy of CaP treatment. Understanding the mechanisms of radioresistance will help to overcome recurrence after RT in CaP patients and prevent metastasis. In this review, we discuss the novel findings of PI3K/Akt/PTEN/mTOR signaling pathway, autophagy, EMT and CSCs in the regulation of CaP metastasis and radioresistance, and focus on combination of radiosensitizers with RT in the treatment of CaP in preclinical studies to explore novel approaches for future clinical trials.     

Pancoast tumor: radiation therapy alone versus preoperative radiation therapy and surgery

This is a retrospective analysis of 73 patients with non-oat cell carcinoma of the lung presenting as a Pancoast tumor. All patients were treated with curative intent between October 1964 and September 1987 (minimum follow-up 2 years). The treatment plan consisted of preoperative radiation therapy (usually 3000 cGy in 2 weeks or 4500 cGy in 5 weeks) in 41 patients and radiation therapy alone (usually 6500-7000 cGy in 6.5-8.0 weeks) in 32 patients. In general, radiation therapy alone was reserved for poor-prognosis patients (extensive disease or medical inoperability). Although 41 patients were initially scheduled to receive preoperative radiation therapy and surgery, the surgery was not performed in 12 cases (29%) because of patient refusal (4 patients), poor response to radiation therapy (4 patients), distant metastasis (2 patients), or debilitation (2 patients). Separate calculations were carried out for the patients who completed the surgery as planned (preoperative radiation therapy and surgery) and the entire group originally scheduled for combined-modality therapy. There was no significant difference in the absolute or cause-specific survival rates between treatment groups, but severe complications were significantly more common in patients receiving combined therapy.     

The roles and controversies of radiation therapy in breast conserving therapy for breast cancer

Breast conserving therapy (BCT) is defined as a combination of conservative surgery for resection of the primary tumor, followed by radiation therapy (RT) for the eradication of residual microscopic disease in the breast. At NIH Consensus Development Conference in 1990, BCT was recognized as the preferred treatment for the majority of women with Stage I and II breast cancer. RT is a potent locoregional treament and its role in BCT in reducing local recurrence is already established. On the other hand, the influence of RT on survival outcome has not yet been closely demonstrated so far. RT appears to be useful as neoadjuvant therapy, and also as exclusive local treatment for patients achieving complete regression (CR) after neoadjuvant chemotherapy. The other possible role of RT is to use it as an alternative to axillary dissection in patients with clinically uninvolved nodes. The question of the appropriateness of using RT in all BCT cases is raised. Since the subgroup of patients who would not deserve any benefit by RT has not yet identified, RT should be delivered as standard treatment following breast conserving surgery for early stage breast cancer.     

Surgical margins and reresection in the management of patients with soft tissue sarcoma using conservative surgery and radiation therapy

BACKGROUND: Patients with localized soft tissue sarcoma (STS) who present to specialist centers after undergoing apparent macroscopic total resection often have a significant incidence of residual tumor and may benefit from reresection of the tumor bed. The potential benefits of such reresection have not been documented adequately. METHODS: The clinicopathologic features and disease outcome for 666 consecutive patients with localized STS who presented after undergoing apparent macroscopic total tumor resection were analyzed to elucidate the relative merits of reresection. Actuarial univariate and multivariate methods were used to compare disease outcome of patients who presented with positive or uncertain microscopic resection margins according to whether they underwent reresection. All patients received adjuvant radiation therapy. RESULTS: Two hundred and ninety-five patients underwent reresection of their tumor bed, and residual tumor was found in 136 patients (46%), including macroscopic tumor in 73 patients (28%). Final resection margins among patients who underwent reresection were negative in 257 patients (87%), positive in 35 patients (12%), and uncertain in 3 patients (1%). Patients who did not undergo reresection had final margins that were negative in 117 patients (32%), positive in 47 patients (13%), and uncertain in 207 patients (56%). Local control rates at 5 years, 10 years, and 15 years for patients who underwent reresection were 85%, 85%, and 82%, respectively; for patients who did not undergo reresection, the respective local control rates were 78%, 73%, and 73% (P = 0.03). Reresection remained a significant determinant of local control when other prognostic factors were incorporated into a multivariate proportional hazards regression analysis. A similar beneficial effect of reresection was found for metastasis free survival and disease specific survival. CONCLUSIONS: Patients with localized STS who were referred to a specialist center after undergoing apparent macroscopic total resection of their tumor had a high incidence of residual tumor in their tumor bed and benefited from undergoing reresection, even if radiation was administered routinely.     

Outcomes of Gamma Knife surgery for craniopharyngiomas

Gamma Knife surgery (GKS) has emerged as a valuable adjuvant treatment modality for recurrent or residual craniopharyngioma. However, prognostic factors pertaining to progression-free survival (PFS) remain poorly understood. A study was conducted to address this issue. A total of 37 consecutive patients undergoing 39 sessions of GKS procedures targeting the solid portions of the tumors at our institution between 1989 and 2005 were analyzed. Twenty-one male and 16 female patients comprised this study. Median age at GKS was 36 years (range, 4–78). Median tumor volume was 1.6 cm³ (range, 0.1–18.6), median marginal dose was 14.5 Gy (range, 6–25), and median maximal dose was 30 Gy (range, 15.6–60). Median follow-up was 50 months (range, 8–212). Univariate and multivariate analyses using Cox proportional hazards model were employed to identify the potential prognostic factors including tumor volume, marginal dose, gender, age at GKS, and status of visual field defect (VFD) in terms of in-field PFS. The actuarial 3- and 5-year in-field PFS were 84.8 and 67.0%, respectively. On univariate analysis, absence of VFD at GKS was a favorable prognostic factor (hazard ratio: 0.279; 95% CI, 0.085–0.913, P = 0.035), whereas on multivariate analysis, absence of VFD at GKS, tumor volume ≤1.6 cm³, and marginal dose >14.5 Gy related to a longer in-field PFS. GKS may offer reasonable control of recurrent or residual craniopharyngiomas. There was a consistent correlation between absence of VFD at the time of GKS and in-field PFS.     

Medulloblastoma: conventional radiation therapy in comparison to chemo radiation therapy in the post-operative treatment of high-risk patients

The aim of this study is to assess treatment results of 48 pediatric high-risk medulloblastoma cases that were treated by surgery, radiotherapy with or without chemotherapy. The impact of adjuvant combination chemotherapy on treatment results will be assessed. Forty-eight cases of pediatric high-risk medulloblastoma treated from July 2001 to July 2004 were randomized into two groups. The first (group I) included 21 patients who received postoperative craniospinal radiation therapy (36Gy+boost 20Gy to the posterior fossa). The second (group II) included 27 cases who received postoperative combination cranio-spinal radiation therapy (with the same dose as the first group) and chemotherapy (vincristine, etoposide, cisplatin). Both groups were compared as regards overall survival (OS), disease free survival (DFS), response rate and treatment toxicity. In-group I, complete remission (CR) was achieved in 71.4% of the cases; partial remission (PR) in 14.3% of the patients; stationary disease (SD) in 14.3% and none of the cases suffered from progressive disease. The three-year OS was 69.5% and the three-year DFS was 61.3%. In-group II, CR was achieved in 59.3% of the cases; PR in 3.7%; SD in 3.7% and PD in 37.3% of the cases. The three-year OS was 48.4% and the 3-year DFS was 48.9%. Regarding acute treatment toxicity in group I, nine patients (31.5%) developed grade I myelo-suppression and seven cases (24.5%) developed grade II myelo-suppression with three to five days treatment interruption. Whereas in group II, 13 patients (45.5%) developed grade I myelosuppression and seven cases (24.5%) developed grade II myelo-suppression requiring interruption of treatment for a period ranging from five to seven days with spontaneous recovery. In group I no other acute toxicity was recognized, whereas in group II other toxicities related to chemotherapy were noticed. For example, three patients (11%) developed peripheral neuritis during the course of treatment and two patients (7%) developed renal impairment, which responded to medical treatment. Late treatment toxicity, manifested as reduction in intelligence quotient (IQ), was noticed, which makes conventional treatment of medulloblastoma unsatisfactory. In group I; 13 patients (62%) suffered a reduction of 8-20% in IQ in comparison to their normal siblings, whereas in Group II; 13 patients (48%) developed a reduction in IQ ranging from 12-21%. CONCLUSION: The current treatment of medulloblasotma has a detrimental effect on long-term survivors. Whereas acute toxicity is considered mild and tolerable, late toxicity regarding diminution in IQ makes current treatment unsatisfactory because of the long-term mental disability of the cured patients. We believe that, the poorer outcome in the chemo-radiation group was due to the treatment interruption during radiation therapy caused by myelosuppression since the incidence of myelosuppression was higher in the chemo-radiation group and the recovery time was longer.     

Importance of the time interval between surgery and postoperative radiation therapy in the combined management of head & neck cancer

Twenty-two patients with advanced carcinomas of various head and neck sites were treated with surgical resection followed by elective postoperative radiation therapy. No patient had gross residual or recurrent disease at the time radiation therapy was started. The time interval from surgery to the start of radiation therapy varied from two and one half weeks to sixteen weeks; the median was seven weeks. Doses of radiation varied from 4500 rad to 5400 rad in five to five and one half weeks.One patient was lost to follow-up. Of the remaining twenty-one patients ten were alive with no evidence of disease (NED) at two to four years (48 %). We observed that 7 of 10 (70 %) of patients whose radiation therapy was started within seven weeks after surgery, were alive free of disease; however, only 3 of 11 (27 %) of those in whom there was a delay of seven weeks or more survived free of disease. Furthermore, in the former group there were virtually no local or regional recurrences, regardless of the stage of the disease, while in the latter group the incidence of local or regional recurrences was 64 %.These data suggest that delay in the start of postoperative radiation therapy, even in the absense of gross recurrent tumor, might adversely affect the results of combined surgical and radiotherapeutic management of head and neck cancers.     

Intensity-modulated radiation therapy in the management of head and neck cancer

PURPOSE OF REVIEW: Intensity-modulated radiation therapy (IMRT) represents a potentially significant new advance in the radiotherapeutic treatment of head and neck cancer patients. The capacity of IMRT to produce highly conformal dose distributions affords the opportunity to decrease the spectrum of toxicities associated with head and neck radiation. This review updates recent advances regarding the use of this emerging technology. RECENT FINDINGS: Mature clinical data demonstrating head and neck IMRT safety and efficacy remain relatively limited to date. Recent publications have sought to clarify target selection and delineation. Refinements in target design driven by clinical outcomes are beginning to emerge. Technical aspects of IMRT delivery such as the impact of daily set-up variation, planning methods, and optimal fractionation regimens are progressing. SUMMARY: Stepwise refinement in the practice of IMRT for head and neck cancer patients is advancing worldwide. However, mature clinical data remains relatively limited and specific aspects regarding the practice of head and neck IMRT remain heterogeneous.     

A comparison of three optimization algorithms for intensity modulated radiation therapy

In intensity modulated treatment techniques, the modulation of each treatment field is obtained using an optimization algorithm. Multiple optimization algorithms have been proposed in the literature, e.g. steepest descent, conjugate gradient, quasi-Newton methods to name a few. The standard optimization algorithm in our in-house inverse planning tool KonRad is a quasi-Newton algorithm. Although this algorithm yields good results, it also has some drawbacks. Thus we implemented an improved optimization algorithm based on the limited-memory Broyden-Fletcher-Goldfarb-Shanno (L-BFGS) routine. In this paper the improved optimization algorithm is described. To compare the two algorithms, several treatment plans are optimized using both algorithms. This included photon (IMRT) as well as proton (IMPT) intensity modulated therapy treatment plans. To present the results in a larger context the widely used conjugate gradient algorithm was also included into this comparison. On average, the improved optimization algorithm was six times faster to reach the same objective function value. However, it resulted not only in an acceleration of the optimization. Due to the faster convergence, the improved optimization algorithm usually terminates the optimization process at a lower objective function value. The average of the observed improvement in the objective function value was 37%. This improvement is clearly visible in the corresponding dose-volume-histograms. The benefit of the improved optimization algorithm is particularly pronounced in proton therapy plans. The conjugate gradient algorithm ranked in between the other two algorithms with an average speedup factor of two and an average improvement of the objective function value of 30%.     

Intraoperative radiation therapy in the management of gynecologic and genitourinary malignancies

Women with locally advanced primary or recurrent gynecologic malignancies have a poor prognosis. The doses of external radiation necessary to treat gross or microscopic recurrent disease in patients previously irradiated exceed the doses tolerated by normal tissue [1,3-5]. IORT has been added to the treatment armamentarium in this group of patients to maximize local control and minimize the radiation exposure to dose-limiting surrounding structures. In addition, IORT may improve the long-term local control and the overall survival rates in women with pelvic sidewall or para-aortic nodal recurrence [1,4,5]. The most encouraging results are seen in cases of microscopic residual disease following surgical debulking [4,6]. In gynecologic malignancies, IORT has served to reiterate the importance of optimal surgical resection. Higher 5-year disease-free and overall survival rates have been documented in women who have microscopic residual disease, compared with those who have gross residual disease [1,3-6]. IORT in the management of GU malignancies has not been used extensively. In RCC, where surgery alone often results in suboptimal treatment results, IORT seems to be well tolerated and controls local disease [2,27,29,30]. Because of the chemoresistant nature of RCC, IORT may play an important role in the future in the management of locally advanced and recurrent RCC. In bladder cancer, IORT had been used in combination with chemotherapy and EBRT, as part of bladder-sparing protocols. The data suggest that IORT in this patient population is also well tolerated, and may become more widely used as less radical surgical procedures gain clinical importance. IORT in the treatment of prostate and testicular cancers has not been used frequently, given the highly efficacious treatment modalities currently available to treat these malignancies. A review of institutional experiences with IORT may allow the establishment of guidelines for patient selection. These criteria, in turn, may be useful in the design of clinical trials. The construction, execution, and evaluation of clinical trials are mandatory to adequately assess the role of IORT in the treatment of patients with gynecologic and GU malignancies.