Gemcitabine-based concurrent chemoradiotherapy versus chemotherapy alone in patients with locally advanced pancreatic cancer

Objective: To explore improved treatment by retrospectively comparing survival time of gemcitabine-basedconcurrent chemoradiotherapy (GemRT) versus chemotherapy (Gem) alone in patients with locally advancedpancreatic cancer (LAPC). Methods: From January 2005 to June 2010, 56 patients with LAPC from Subei People’sHospital were treated either with Gem (n=21) or GemRT (n=35). Gem consisted of 4-6 cycles gemcitabine alone(1000 mg/m2 on Days 1, 8, 15, 28-day a cycle). GemRT consisted of 50.4Gy/28F radiotherapy with concurrent 2cycles of gemcitabine (1000 mg/m2 on days of radiation 1, 8, 15, 21-day a cycle). Radiation was delivered to thegross tumor volume plus 1-1.5 cm by use of a three-dimensional conformal technique. The follow-up time wascalculated from the time of diagnosis to the date of death or last contact. Kaplan-Meier methodology wes usedto evaluate survival. Results: Patient characteristics were not significantly different between treatment groups.The disease control rate and the objective response rate of GemRT versus Gem was 97.1% vs 71.4%, 74.3%vs 38.1%. The overall survival (OS) was significantly better for GemRT compared to Gem (median 13 monthsversus 8 months; 51.4% versus 14.3% at 1 year, respectively). Conclusion: Radiation therapy at 50.4Gy with2 concurrent cycles of gemcitabine results in favorable rates of OS. Concurrent chemoradiotherapy should bethe first choice for patients with LAPC.     

Intensified concurrent chemoradiotherapy with 5-fluorouracil and irinotecan as neoadjuvant treatment in patients with locally advanced rectal cancer

This study aimed to evaluate the feasibility and efficacy of neoadjuvant chemoradiotherapy intensified with irinotecan in patients with locally advanced rectal cancer. Eligible patients had nonmetastatic disease at a locally advanced stage that made R0 resection and sphincter preservation uncertain. They received preoperative radiation over 6 weeks to 45 Gy and boost of 5.4 Gy and concurrent continuous infusion 5-fluorouracil 250 mg m(-2) day(-1) and weekly irinotecan 40 mg m(-2). In all, 37 patients entered the study. T stage at baseline as determined by ultrasound was T2/T3/T4 in 2/19/16 patients; 31 patients had lymph node involvement. The predominant toxicity was diarrhoea (grade 3/4 in 10/2 patients). Haematologic toxicity and surgical complications were moderate. Among 36 patients undergoing surgery, 32 (89%) had R0 resection and 23 (64%) sphincter preservation. Pathologic complete response (pCR) was achieved in eight (22%) of 36 patients, and 10 patients (28%) had only microscopic residual disease. At 4 years, overall survival was 66%, disease-free survival 73%, local relapse rate 7%, and distant failure rate 24%. Extent of resection and postoperative nodal status were significant predictors of overall and disease-free survival. Intensified neoadjuvant chemoradiotherapy with irinotecan can be safely administered and results in a high pCR rate.     

Weekly full-dose gemcitabine and single-dose cisplatin with concurrent radiotherapy in patients with locally advanced pancreatic cancer

The aim of this study was to evaluate the efficacy and the toxicity of a full dose of gemcitabine and a single dose of cisplatin with concurrent radiotherapy in patients with locally advanced pancreatic cancer. Forty-one patients with locally advanced pancreatic cancer were enrolled. Patients received gemcitabine (1000 mg m(-2) on days 1, 8, 15, 29, and 36) and cisplatin (70 mg m(-2) on days 1 and 29) with concurrent radiotherapy (45 Gy in 25 fractions). Treatment was completed in 38 out of 41 patients (92.7%). The overall response rate was 24.4% (two complete and eight partial). Six patients (14.6%) underwent definite pancreatic resection and four had negative surgical margins. The intention of the treatment analysis showed that the median survival time and median time to tumour progression were 16.7 and 8.9 months. The 1- and 2-year survival rates were 63.3 and 27.9%, respectively. Overall survival was significantly longer in the low baseline CA19-9 group and therapeutic responders. Toxicities were tolerable and successfully managed by conservative treatments. The therapeutic scheme of a weekly full dose of gemcitabine and a single dose of cisplatin combined with external radiation is effective and might prolong the survival of patients with locally advanced pancreatic cancer.     

Low-dose trimetrexate glucuronate and protracted 5-fluorouracil infusion in previously untreated patients with advanced pancreatic cancer.

BACKGROUND: 5-Fluorouracil (5-FU)-based regimens have not been shown to prolong survival or provide clinical benefit in patients with advanced pancreatic cancer. The purpose of this study was to determine the tolerability of protracted venous infusion (PVI) of 5-FU, modulated by a low dose of the synthetic antifolate trimetrexate, in patients with advanced pancreatic cancer. PATIENTS AND METHODS: Twenty-three chemotherapy-na?ve patients were evaluated. Patients were enrolled in four consecutive cohorts in which the weekly dose of trimetrexate was escalated in 10 mg/m2 increments, from 20 to 50 mg/m2. PVI 5-FU was administered at a fixed dose of 225 mg/m2/day. Treatment was administered for 6 successive weeks, every 8 weeks. RESULTS: Twenty-two patients were assessable. The maximum tolerated dose of trimetrexate was 40 mg/m2. The most common grade 3 and 4 toxicity was diarrhea. There were no treatment-related deaths. Preliminary analysis of activity revealed a response rate of 9%, with 41% of the patients having stable disease for a median duration of 3.8 months. The median survival for the entire group was 6.9 months (range 1-29 months). A clinical benefit response was experienced by 27.2% of patients. CONCLUSIONS: Low-dose trimetrexate can be safely administered in combination with PVI 5-FU. This treatment is well tolerated and is associated with palliative activity in advanced pancreatic cancer.     

Concurrent chemoradiotherapy with protracted infusion of 5-fluorouracil (5-FU) and cisplatin for locally advanced resectable esophageal cancer

Background

Neoadjuvant concurrent chemoradiotherapy (CCRT) has become the standard treatment for esophageal cancer (EC) in North America. The cisplatin/5-flurouracil (5-FU) combination has been the most commonly used regimen. For the last 15 years we incorporated a daily continuous infusion of 5-FU and 2 doses of cisplatin into our neoadjuvant CCRT for potentially resectable EC.

Patients and methods

Between July 1997 and June 2012, 129 patients with locally advanced EC (T3 or N1 and higher), received neoadjuvant CCRT with cisplatin 75 mg/m² on day 1 and day 29 and continuous infusion of 5-FU (225 mg/m²/day) on the days of radiation.

Results

The median age of patients was 63 years, 85% had adenocarcinoma, 29, 74 and 26 patients had stage II, III and IVa disease respectively, 110 patients had N1 disease based on the American Joint Committee on Cancer (AJCC) 6^th edition, 118 patients experienced weight loss during treatment. All patients completed treatment. Treatment was well tolerated with 14% of patients having ≥ grade 3 toxicity and 18 patients requiring hospital admission. Sixty-four percent of patients had surgical resection following CCRT, with disease progression and patient refusal being the most common reasons for not proceeding with surgery. An R0 resection was achieved in 96% of patients. A pathological complete response (pCR) was achieved in 45% of patients. With a median follow up of 26 months (1.2-144 months), 48/129 patients recurred and 60/129 died of their disease.

Conclusions

Our study has its limitation, however, and compared to the conventional chemotherapy regimens containing the cisplatin/5-FU doublet, our treatment strategy for locally advanced EC CCRT seems to be feasible and well tolerated.     

Preoperative concurrent chemoradiotherapy with cisplatin and docetaxel in patients with locally advanced non-small-cell lung cancer

The objective of this study was to assess the feasibility and effectiveness of an induction chemoradiotherapy regimen followed by surgery in patients with locally advanced non-small-cell lung cancer (LA-NSCLC). A total of 22 patients with LA-NSCLC were treated with induction chemoradiotherapy consisting of cisplatin (40 mg m(-2)) and docetaxel (40 mg m(-2)) given on days 1, 8, 29 and 36 plus concurrent thoracic irradiation at a dose of 40-60 Gy (2 Gy fraction(-1) day(-1)). Surgical resection was performed within 6 weeks after completion of induction therapy. Objective response to the induction therapy was obtained in 16 patients (73%). In all, 20 patients (91%) underwent surgery and complete resection was achieved in 19 patients (86%). Pathological downstaging and pathological complete response were obtained in 14 (64%) and five (23%) patients, respectively. With a median follow-up period of 32 months, the calculated 3-year overall and progression-free survival rates were 66 and 61%, respectively. It is noteworthy that the 3-year overall survival rate in 14 patients achieving pathological downstaging was extremely high (93%). Toxicity was manageable with standard approaches. No treatment-related deaths occurred. This combined modality treatment is feasible and highly effective in patients with LA-NSCLC. The results warrant further large-scale study to confirm the effectiveness of this regimen.     

序贯化放疗治疗局部晚期胃癌的临床疗效

目的:观察化疗-放疗-化疗(化-放-化)序贯治疗局部晚期胃癌的临床疗效和毒副反应.方法:2009年1月-2014年10月我科收治的局部晚期胃癌84例,采用同期对照研究,分为化-放-化序贯治疗组(观察组)44例和单纯化疗组(对照组)40例.观察组及对照组均采用DCF(多西他赛、顺铂、5-氟尿嘧啶)或FOLFOX4(5-氟尿嘧啶、奥沙利铂、亚叶酸钙)方案化疗3~4周期,观察组化疗2周期后开始肿瘤累及区域三维适形放疗/调强适形放射治疗(3DCRT/IMRT),放疗剂量DT(45~50.4)Gy/[(25~28)f?(5~6)w],放疗结束再予相同方案化疗1~2周期.对照组不予放疗.结果:84例患者均可评价疗效,观察组与对照组总有效率(CR+PR)分别为65.9%、37.5%,疾病控制率(CR+PR+SD)分别为88.6%、60.0%,临床症状缓解率分别为88.6%、65.0%,中位生存期分别为12.0个月、10.0个月,1、2年生存率分别为56.8% vs 32.5%、18.2% vs 7.5%.两组比较,在治疗有效率、疾病控制率、临床症状缓解率、中位生存期、1年生存率方面观察组高于对照组,差异具有统计学意义;2年生存率观察组较对照组有增高,但无统计学差异.两组Ⅲ-Ⅳ度骨髓抑制、胃肠道反应、肝肾功能受损发生率相近.结论:序贯化放疗较单纯化疗提高了局部晚期胃癌的治疗有效率,明显缓解患者的临床症状,且使部分患者改善了生存质量,延长生存期,并未增加治疗毒副反应,是不能手术局部晚期胃癌的较好治疗方案.     

紫杉醇联合顺铂方案同步放疗治疗局部进展期宫颈癌的疗效分析

目的 分析紫杉醇联合顺铂方案同步放疗对局部进展期宫颈癌患者的疗效及不良反应.方法 选取局部进展期宫颈癌患者68例,FIGOⅢ~Ⅳa期,接受根治性放疗,累积剂量为80 Gy,同时每周给予顺铂30 mg/m2+紫杉醇50 mg/m2.观察记录患者的疗效及不良反应.结果 68例患者的不良反应包括胃肠道损害、贫血及脑梗死等,2年累积远期不良反应发生率为25%.中位随访时间27个月,2年PFS为83.8%(75.1%~92.6%),2年OS为92.7%(86.4%~98.9%),2年DM为13.2%(5.2%~21.3%).结论 紫杉醇联合顺铂同步放疗治疗局部进展期宫颈癌的疗效显著,且方案安全可行.     

Gemcitabine combined with continuous infusion 5-fluorouracil in advanced and symptomatic pancreatic cancer: a clinical benefit-oriented phase II study

Gemcitabine and 5-fluorouracil are the only two compounds with reproducible activity against advanced pancreatic cancer (APC). We have evaluated a novel combination of gemcitabine and 5-fluorouracil on the clinical benefit response (CBR) end point. Eleven consecutive patients with symptomatic APC were entered in a two-stage phase II trial. Gemcitabine was administered by intravenous (i.v.) bolus injection at the dose of 1,000 mg m(-2) on days 1, 8, 15 and 5-fluorouracil 500 mg m(-2) was given by continuous i.v. infusion on days 1-5. Treatment was repeated every 28 days. A CBR was achieved in 7/11 patients. The mean time to loss of CBR was 26.5 weeks (range 14-18, median 22). Toxicity was mild and no APC patient experienced WHO grade 3 toxicity. The gemcitabine/5-fluorouracil combination is well tolerated and produces a symptomatic relief in the majority of APC patients.     

局部晚期宫颈癌同步放化疗临床观察

目的探讨同步放化疗治疗局部晚期宫颈癌的疗效和不良反应。方法 80例经病理确诊、临床分期为Ⅱb~Ⅲb期局部晚期宫颈癌患者随机分成两组,每组各40例,均予根治性放疗,体外放疗均采用直线加速器15 MV X射线,DT46~50 Gy,腔内治疗采用192Ir后装机,A点6 Gy/周,总剂量为36~42 Gy。两组放疗方法相同,同步放化疗组在放疗前每周日加用多西紫杉醇(希存)40 mg静滴,共6周。观察近期疗效、3年生存率及放化疗并发症。结果放疗后3个月同步放化疗组有效率(100%)明显高于单纯放疗组72.5%(P<0.05),局部复发率、远处转移率两组分别为5.0%、2.5%和17.5%、15.0%,差异有统计学意义(P<0.05);3年生存率分别为82.5%和55.0%(P<0.05),而毒副作用无明显增加(P>0.05)。结论同步放化疗能提高局部晚期宫颈癌患者的疗效及生存率,降低局部复发率及远处转移率。     

A phase I trial of S-1 with concurrent radiotherapy for locally advanced pancreatic cancer

This study investigated the maximum tolerated dose of S-1 based on the frequency of its dose-limiting toxicities (DLT) with concurrent radiotherapy in patients with locally advanced pancreatic cancer. S-1 was administered orally at escalating doses from 50 to 80 mg m(-2) b.i.d. on the day of irradiation during radiotherapy. Radiation therapy was delivered through four fields as a total dose of 50.4 Gy in 28 fractions over 5.5 weeks, and no prophylactic nodal irradiation was given. Twenty-one patients (50 three; 60 five; 70 six; 80 mg m(-2) seven patients) were enrolled in this trial. At a dose of 70 mg m(-2) S-1, two of six patients demonstrated DLT involving grade 3 nausea and vomiting and grade 3 haemorrhagic gastritis, whereas no patients at doses other than 70 mg m(-2) demonstrated any sign of DLT. Among the 21 enrolled patients, four (19.0%) showed a partial response. The median progression-free survival time and median survival time for the patients overall were 8.9 and 11.0 months, respectively. The recommended dose of S-1 therapy with concurrent radiotherapy is 80 mg m(-2) day(-1). A multi-institutional phase II trial of this regimen in patients with locally advanced pancreatic cancer is now underway.     

Phase I study of hyperfractionated radiation therapy with protracted 5-fluorouracil infusion in patients with locally advanced pancreatic cancer

OBJECTIVE: This study investigated the maximum-tolerated dose of hyperfractionated radiation therapy with protracted 5-fluorouracil (5-FU) infusion in patients with locally advanced, unresectable pancreatic cancer. METHODS: Five cohorts of patients were scheduled to receive escalating doses of hyperfractionated radiation therapy (range, 45.6-64.8 Gy). All patients received two fractions of 1.2 Gy each (separated by 6 h) per day for 5 days a week, and received protracted 5-FU infusion (200 mg/m2/day) during the radiation course. The maximum-tolerated dose was defined as one dose level below the dose at which more than one third of 3-6 patients experienced dose-limiting toxicity. RESULTS: Twenty-nine patients were enrolled in this study. The most common toxicities were nausea/vomiting and anorexia. Although 1 patient developed bleeding from a gastric ulcer 3 months after the completion of chemoradiotherapy, the maximum-tolerated dose was not reached even at the highest dose level (level 5, 64.8 Gy). The median survival time was 12.2 months and the 1-year survival rate was 55.0%. CONCLUSION: The toxicity associated with our regimen was tolerable up to dose level 5 (64.8 Gy). We are currently conducting a phase II study of this hyperfractionated radiation therapy with protracted 5-FU infusion at a dose of 64.8 Gy.     

局部晚期低位直肠癌术前同步放化疗的疗效观察

目的 探讨术前同步放化疗治疗局部晚期低位直肠癌的安全性和有效性.方法 对临床分期属T3/T4低位直肠癌患者分为A组和B组.A组28例患者,给予术前放疗,同步口服卡培他滨.B组26例患者直接给予手术.结果 A组和B组根治术率分别为82.1％和50.0％ (P ＜0.01),保肛率分别为64.3％和26.9％ (P＜0.0...     

Comparison of 5-fluorouracil/leucovorin and capecitabine in preoperative chemoradiotherapy for locally advanced rectal cancer

PURPOSE: To describe our experience with a bolus injection of 5-fluorouracil and leucovorin (FL) vs. capecitabine in terms of radiologic and pathologic findings in preoperative chemoradiotherapy (CRT) for locally advanced rectal cancer. METHODS: The study enrolled 278 patients scheduled for preoperative CRT using two protocols with different chemotherapeutic regimens. Pelvic radiotherapy (50.4 Gy) was delivered concurrently with FL (n = 145) or capecitabine (n = 133). Surgery was performed 6 weeks after CRT completion. Tumor responses to CRT were measured using both radiologic and pathologic examination. Magnetic resonance volumetry was performed at the initial workup and just before surgery after completion of preoperative CRT. Post-CRT pathology tests were used to determine tumor stage and regression. RESULTS: Radiologic examination showed that tumor volume decreased by 68.2% +/- 20.5% in the FL group and 68.3% +/- 22.3% in the capecitabine group (p = 0.970). Postoperative pathologic T stage determination showed that downstaging occurred in 44.3% of FL and 49.9% of capecitabine patients (p = 0.571). The tumor regression grades after CRT were Grade 1 (minimal response) in 22.6% and 21.0%, Grade 2 (moderate response) in 53.2% and 50.0%, Grade 3 (near-complete response) in 12.9% and 12.9%, and Grade 4 (complete response) in 11.3% and 16.1% of the FL and capecitabine groups, respectively (p = 0.758). CONCLUSION: In the present study, the radiologic and pathologic findings did not reveal significant differences in short-term tumor responses between preoperative FL and capecitabine CRT for locally advanced rectal cancer. Long-term results and a prospective randomized trial are needed.     

局部进展期直肠癌术前新辅助治疗疗效分析

目的 观察术前同期放化疗或术前单纯放疗在T3、T4期或影像学淋巴结阳性直肠癌患者治疗中的疗效和安全性.方法 回顾分析2000 -2009年收治的141例局部进展期或影像学淋巴结阳性的直肠癌患者资料,其中术前同期放化疗97例,术前单纯放疗44例.放疗采用二维或三维技术,化疗采用4种方案.结果 随访率为91.5％,随访满3、5年者分别为106、68例.降期率达59.0％ (82/139),保肛手术率达65.5％ (91/139).3、5年总生存率分别为85.8％、65.7％,局部复发率分别为9.2％、14.1％,转移率分别为33.8％、45.8％.术前同期放化疗患者中位无瘤生存期优于术前单纯放疗(51:31个月,x2=12.88,P=0.000).肿瘤降期患者在远处转移时间上迟于未降期患者(60:29个月,x2=14.65,P=0.000).急性不良反应多为1、2级,伤口愈合延迟及吻合口瘘发生率低.结论 术前同期放化疗或术前单纯放疗能明显降低肿瘤分期、提高手术保肛率,不良反应小且绝大多数患者可耐受.     

不能手术局部晚期非小细胞肺癌同步或序贯放化疗85例临床分析

目的：评价不能手术局部晚期非小细胞肺癌（ NSCLC）患者同步或序贯放化疗的疗效和不良反应。方法：2011年7月至2013年12月间初治接受同步或序贯放化疗的85例患者入组本研究,其中45例同步放化疗患者列入A组,40例序贯放化疗患者列入B组。A组采用放疗同步紫杉醇、顺铂化疗,B组采用单纯放疗,放疗结束后行紫杉醇、顺铂化疗。两组放疗方法相同,均为三维适型放疗,剂量60Gy/30f。对比两组治疗的疗效、不良反应和1、2年生存率。结果：85例患者均可评价疗效,随访率100%。A组与B组有效率分别为73.3%和50.0%（P﹤0.05）;1年局部控制率分别为51.1%和30.0%（P﹤0.05）;1年生存率分别为62.2%和42.5%（P﹥0.05）;2年生存率分别为37.8%和17.5%（P﹤0.05）。A组≥Ⅲ级放射性肺炎、放射性食管炎及Ⅲ~Ⅳ级骨髓抑制的发生率分别为6.7%、11.1%和28.9%,B组分别为5.0%、10.0%和27.5%。两组不良反应相似,均可耐受。结论：局部晚期NSCLC同步放化疗的疗效优于序贯放化疗,不良反应可耐受,同步放化疗是不能手术的局部晚期NSCLC标准治疗方法。     

Phase II study of radiotherapy combined with gemcitabine for locally advanced pancreatic cancer

Gemcitabine has been reported to be a potent radiosensitiser in human pancreatic cell lines. This study was conducted to evaluate the efficacy and toxicity of radiotherapy combined with gemcitabine for locally advanced pancreatic cancer. In all, 42 patients with pancreatic cancer that was unresectable but confined to the pancreatic region were treated with external-beam radiation (50.4 Gy in 28 fractions over 5.5 weeks) and weekly gemcitabine (250 mg m(-2), 30-min infusion). Maintenance gemcitabine (1000 mg m(-2) weekly x 3 every 4 weeks) was initiated 1 month after the completion of the chemoradiotherapy and continued until disease progression or unacceptable toxicity. Of the 42 patients, 38 (90%) completed the scheduled course of chemoradiotherapy. The major toxicity was leucopenia and anorexia. There was one death attributed to duodenal bleeding and sepsis. The median survival time was 9.5 months and the 1-year survival rate was 28%. The median progression-free survival time was 4.4 months. In 35 patients with documented disease progression at the time of analysis, 34 (97%) showed distant metastasis as the cause of the initial disease progression. The chemoradiotherapy used in this study has a moderate activity against locally advanced pancreatic cancer and an acceptable toxicity profile. Future investigations for treatment with more systemic effects are warranted.     

Phase II trial of S-1 and concurrent radiotherapy in patients with locally advanced pancreatic cancer

Purpose  S-1 has a favorable effect in unresectable pancreatic cancer and a potential radiosensitizer. In addition, daily oral administration of S-1 is more convenient than continuous infusion of 5-fluorouracil. This study was designed to evaluate the efficacy and safety of S-1 and concurrent radiotherapy in patients with locally advanced pancreatic cancer. Methods  Eligibility criteria were histologically proven pancreatic adenocarcinoma, locally advanced disease, and no previous treatment. S-1 was administered orally at a dose of 40 mg/m² twice daily from day 1 to 14 and from day 22 to 35, and concurrent radiotherapy (a total dose of 50.4 Gy) was delivered in 28 fractions. One month after treatment completion, tumor response was evaluated by computed tomography (CT). Results  A total of 25 patients were evaluable for efficacy and toxicity on the basis of the intention-to-treat analysis. The response rate and disease control rate were 24.0 and 68.0%, respectively. There was no treatment-related death or grade 4 toxicity. The most common grade 3 hematologic and non-hematologic toxicities were thrombocytopenia (4.0%) and anorexia (20%), respectively. All toxicities were tolerable and transient. The median time-to-progression and median overall survival were 6.5 months (95% confidence interval, 4.1–9.0 months) and 12.9 months (95% confidence interval, 6.7–19.0 months), respectively, and the 1-year survival rate was estimated to be 43%. Conclusions  S-1 and concurrent radiotherapy shows favorable efficacy for disease control against locally advanced pancreatic cancer and was well tolerated with no severe toxicities.     

Intraoperative and conformal external-beam radiation therapy with protracted 5-fluorouracil infusion in patients with locally advanced pancreatic carcinoma

BACKGROUND: Chemoradiotherapy is widely used for patients with locally advanced pancreatic carcinoma. The purpose of this study was to clarify the efficacy and feasibility of chemoradiotherapy with more intensive radiotherapy in these patients, using a combination of intraoperative radiotherapy (IORT), conformal external-beam radiaotherapy (EBRT), and protracted 5-fluorouracil (5-FU). METHODS: Thirty patients with unresectable locally advanced pancreatic carcinoma were enrolled in this Phase II study. The treatment consisted of IORT (25 grays [Gy]), followed by EBRT (40 Gy in 20 fractions, 5 times per week), and concurrent protracted 5-FU infusion (200 mg/m(2)), beginning 2-4 weeks after IORT. The authors evaluated the efficacy and adverse effects of this treatment by following up patients for 12.0-28.1 months. Survival from the date of IORT was calculated using the Kaplan-Meier method. RESULTS: In 11 of the 30 patients, metastatic spread was detected in the abdominal cavity at laparotomy. The full EBRT dose was administered in 28 of the 30 patients. Of the remaining 2 patients, EBRT was terminated at 8 Gy due to progression of brain metastasis and another patient did not receive EBRT or chemotherapy due to massive ascites after IORT. The overall response rate for primary pancreatic tumor on dynamic computed tomography scan was 23.3% (7 partial responses). Grade 3 or 4 toxicity (according to the National Cancer Institute Common Toxicity Criteria) was observed in 15 of the 28 patients who received the full irradiation dose (53.6%). These included anorexia, nausea, emesis, fatigue, leukopenia, and/or elevation of transaminase levels. There were no directly treatment-related deaths, but 1 patient died of hepatic failure related to late effects of irradiation after 25.6 months. The median survival time of the 30 patients was 7.8 months and the 2-year survival rate was 8.1%. The median survival time of the 19 patients without metastatic spread in the abdominal cavity was 12.9 months and that of the 11 patients with metastatic spread was 5.8 months. CONCLUSIONS: The present regimen of chemoradiotherapy is not superior to conventional chemoradiotherapy (EBRT and 5-FU) for patients with locally advanced pancreatic carcinoma.