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1.
晚期胰腺癌术中放射治疗的疗效评价   总被引:2,自引:0,他引:2  
目的 探讨术中放射治疗对晚期胰腺癌的疗效. 方法 对16例晚期胰腺癌患者作姑息性手术加术中放疗,用9-15Mev电子线照射病灶区域,照射20~25 Gy,并与同期未作术中放疗的20例姑息性手术治疗的患者(对照组)进行疗效比较. 结果 术中放疗组腰背痛及腹痛缓解率为93.8%(15/16),对照组腰背痛及腹痛缓解率为40.0%(8/20)(P<0.01),术中放疗组中位生存期为13.5月,对照组为8.6月(P<0.05). 结论 姑息手术联合术中放疗能有效地缓解晚期胰腺癌患者的腰背痛及腹痛,并可延长生存期.  相似文献   

2.
目的 探讨以伊立替康为基础的术后化疗、介入治疗、放射治疗对大肠癌术后肝转移的疗效,比较三种治疗方案的疗效差异.方法 对术后并辅助化疗后异时性肝转移的90例无法手术切除的患者,随机分为三组,分别采用以伊立替康为基础的全身化疗加肝动脉灌注介入(A组);全身化疗加伽马刀局部治疗(B组)和单纯全身化疗(C组).结果 A、B、C各组的6个月生存率分别为100%、80%、80%,12个月生存率分别为70%、50%、30%,24个月生存率分别为33.3%、16.7%、0.中位生存期分别为20、18、14月.结论 大肠癌肝转移的治疗效果不容乐观,对无法手术的患者,以伊立替康为基础的全身化疗加肝动脉介入或者加伽马刀治疗是一个可以考虑的选择,单纯全身化疗不宜作为首选.  相似文献   

3.
目的 探讨胃癌术后放化疗的临床意义、治疗方法和毒副反应。方法 将 1995~ 1998年 10 6例晚期胃癌 (ⅢB~Ⅳ期 )根治术后的病人随机分为 :常规放射治疗组 (单放组 ) 5 3例 ,术后高危区域常规外照射总量DT5 4Gy ,每次 1 8Gy ,每周 5次 ,均采用 8MVX线照射 ;综合组 5 3例 ,外照射同常规放射治疗组 ,放射治疗当日及外照射达DT4 0Gy时 ,同时合并化疗。化疗方案 :5 氟尿嘧啶 (5 FU) 5 0 0mg/d ,5d ;亚叶酸钙 (CF) 2 0 0mg/d ,5d。 结果 全部病人随访 5年以上 ,随访率 96 2 %。局控率综合组和单放组分别为 5 8 5 %和 4 1 5 % (P >0 0 5 ) ;综合组和单放组的 1、3、5年生存率分别为 :81 1%、5 0 9%、34 0 %和 6 9 8%、35 9%、2 0 8%。 3、5年生存率差异有显著性 (P <0 0 5 )。综合组的毒副反应高于单放组。结论 晚期胃癌 (ⅢB~Ⅳ期 )根治术后放疗合并 5 FU加CF化疗优于单纯术后放疗 ,是晚期胃癌术后治疗的一种有效方法  相似文献   

4.
目的 探讨铁氧还原蛋白1(FDX1)在胶质瘤中的表达水平和预后意义。方法 采用免疫组织化学法检测我院神经外科40例恶性胶质瘤样本和20例外伤性脑组织样本中FDX1的表达水平,分析其与患者临床病理因素和预后的关系。结果 FDX1在恶性胶质瘤组织中的蛋白表达水平显著高于外伤性脑组织(P<0.01);FDX1的表达与恶性胶质瘤病理分级呈正相关(P<0.01);Kaplan-Meier生存分析显示FDX1高表达组患者总生存率显著低于低表达组患者(P<0.01)。Cox多因素回归模型显示FDX1表达强度(相对危险度为2.003,P<0.01)和肿瘤分级(相对危险度为2.279,P<0.01)是恶性胶质瘤患者预后的独立危险因素。结论 FDX1高表达与恶性胶质瘤的发生发展有关,对患者总体生存时间有显著影响,可能是胶质瘤患者预后不良的重要指标。  相似文献   

5.
目的 比较陀螺旋转式60Co放射治疗联合化疗和单纯化疗在进展期胰腺癌中的临床疗效。方法 自2012年1月至2014年1月,前瞻性纳入进展期胰腺癌患者100例,根据完全随机数字表原则将患者分为实验组(n=50)和对照组(n=50),实验组采用陀螺旋转式60Co放射治疗联合化疗,对照组采用单纯化疗。比较两组临床预后和治疗相关并发症。结果 与对照组比较,实验组治疗6个月后部分缓解率显著增高(50% vs 30%,P=0.041),病情进展率显著降低(22% vs 42%,P=0.032),健康相关的生存质量显著增高(65.87±9.90 vs 59.03±10.32,P=0.017);实验组24个月病死率显著降低(46% vs 70%,P=0.015),无进展生存期显著延长(P=0.047)。实验组60Co放射治疗后,1级早期放射性损伤28例,2级5例,3级1例,4级1例。结论 陀螺旋转式60Co放射治疗联合化疗显著改善进展期胰腺癌患者临床预后。  相似文献   

6.
目的:比较三维适形放疗同步化疗和三维适形放疗在中晚期宫颈癌治疗中的疗效及副作用.方法:2004年1月至2010年6月,在我科住院的Ⅱb~Ⅳa不同期别宫颈癌118例,随机分为放化组及放疗组各59例,两组均采用全盆照射(40Gy/20次28~30天)、三维适形放疗(26~36Gy/13~18次,17~22天),放化组从放疗的第一周起进行化疗,化疗方案主要以含顺铂方案.结果:放化组、放疗组的近期有效率(CR+PR)均为100%,3年生存率为81.4%(48/59)、64.4%(38/59)(P=0.038),3年无瘤生存率分别为66.1%(39/59),、42.4%(25/59)(p=0.01 0);3年局部复发率分别为16.9%(10/59),、35.6%(21/59)(P=0.021);3年远处转移率分别为;15.3%(9/59)、30.5%(18/59)(P=0.049).结论:三维适形放疗同步化疗中晚期宫颈癌有较好疗效,毒副作用可以耐受.  相似文献   

7.
目的 探究乳腺癌辅助化疗后预防性使用聚乙二醇化重组人粒细胞刺激因子(PEG-rhG-CSF)的成本效果及对生活质量的影响。方法 本研究是一项前瞻性队列研究。纳入我科乳腺癌辅助化疗的患者,根据是否预防性使用PEG-rhG-CSF分组,并进行血常规监测。比较两组化疗间期重度粒细胞减少发生率、延迟化疗率、成本费用指标及生活质量,计算增量成本效果比(Incremental cost benefit ratio,ICER)。结果 共256例患者纳入分析。与对照组相比,PEG-rhG-CSF组重度中性粒细胞减少和延迟化疗的发生率较低,生理状况方面生活质量更好,总费用稍高,针对重度粒细胞减少发生率和延迟化疗率的ICER分别为25.32元/1%和24.45元/1%。结论 乳腺癌辅助化疗后预防性使用PEG-rhG-CSF效果良好并提高生活质量,性价比较高。  相似文献   

8.
目的 探讨脾脏占位性病变合理的诊治方法.方法 回顾性分析我院1999年1月至2007年12月间收治的41例脾脏占位性病变的临床资料.结果 ①良性病变31例,占75.6%;恶性病变10例,占24.4%.②18例行B超检查,27例CT检查提示脾脏占位性病变.③单纯脾脏切除术31例,脾切除术加胰尾淋巴结清扫2例,原发灶加脾切除术2例,脾脏脓肿切开引流术3例,2例脾脓肿和1例脾结核行非手术治疗.④全组无手术死亡;31例良性病变疗效良好,并发胰瘘1例,并发昏迷、肺部感染、缺血性脑病1例,均经非手术治疗而愈;10例恶性病变近期疗效良好,远期疗效较差.结论 ①脾脏占位性病变以原发性病变为主,后者又以良性多见.②B超、CT检查仍是发现脾脏占位性病变的主要手段,术中快速切片检查可作为术前定性诊断的弥补措施.③脾脏原发性病变应首选脾切除术,手术方式可选择开腹或腹腔镜手术,恶性病变还需附加淋巴结廓清,术后可辅以放疗、化疗.  相似文献   

9.
目的 描述肝门部胆管癌患者经皮胆道裸支架植入术的操作方法,评估操作的安全性;分析胆道裸支架植入术联合放疗是否延长不可手术切除的肝门部胆管癌患者支架通畅时间和生存时间。方法 回顾性分析海军总医院和粤北人民医院肝胆外科2007年2月至2013年9月间不能手术切除肝门部胆管癌行经皮胆道裸支架植入术者38例临床资料,均在超声以及透视下行支架植入术。25例接受支架联合放疗(UMS+RT组),13例接受单纯支架治疗(UMS组)。收集患者支架植入术并发症发生情况;分析比较两组间支架通畅时间和生存时间的差异。结果 经皮胆道裸支架植入术技术成功率为100%,胆道引流成功率为86.8%,早期并发症发生率为15.8%,手术相关病死率为2.6%。支架联合放疗组的中位支架通畅时间为326 d,单纯支架组中位支架通畅时间为196 d(P=0.022);支架联合放疗组生存时间明显长于单纯支架组(中位生存时间:367 d vs 267 d,P=0.025)。结论 本研究结果显示经皮胆道裸支架植入术为不可手术切除肝门部胆管癌提供一种安全、有效的姑息治疗方法,支架联合放疗有助于延长支架通畅时间以及生存时间。  相似文献   

10.
目的 胆囊腺鳞癌的预后很差,本研究目的是寻找胆囊腺鳞癌预后的影响因素,评价放化疗对胆囊腺鳞癌预后的意义。方法 从SEER数据库中分析2004年1月至2015年12月214例胆囊腺鳞癌患者的临床病例资料,采用Kaplan-Meier法分析患者预后的影响因素,采用单因素和多因素Cox分析法探讨胆囊腺鳞癌的独立预后因素。结果 胆囊腺鳞癌患者中位生存时间为8个月,1年生存率为34.4%,3年生存率为17.1%。多因素分析结果表明,年龄(HR 1.407,95%CI 1.019~1.944,P=0.038)、M分期(HR 2.219,95%CI 1.595~3.086,P<0.001)、放疗(HR 1.609,95%CI 1.010~2.564,P=0.045)、化疗(HR 1.594,95%CI 1.101~2.307,P=0.013)是胆囊腺鳞癌患者预后的独立因素。42例患者同时接受了化疗和放疗,中位总生存期(OS)为16个月,明显优于未放化疗组(121例,中位OS为5个月)和仅化疗组(49例,中位OS为10个月)。放化疗可提高患者的生存时间(χ2=12.25,P<0.05)。在TNM分期II期和IV期亚组中,同时接受化疗和放疗的胆囊腺鳞癌患者OS比仅接受化疗的患者更长。结论 年龄、M分期、放疗、化疗是胆囊腺鳞癌患者的独立预后因素,放疗联合化疗可以有效改善胆囊腺鳞癌患者的预后。  相似文献   

11.
目的 分析三维适形放疗治疗晚期胰腺癌的疗效及相关预后因素.方法 50例不能手术的晚期胰腺癌病人,采用常规分割的三维适形放疗;其中14例采用姑息性放疗(A组),给予10.8~56 Gy;27例采用单一三维适形放疗(B组),剂量范围为8~60.5 Gy;9例采用同步放化疗的方法(C组),剂量范围为10~64 Gy.同步放化疗中化疗采用吉西他滨(200~600 mg/m~2,1次/周).结果 随访时间为3~35个月,死亡43例,死亡原因主要为肝脏和(或)腹腔内的广泛转移、恶液质、继发感染和出血.存活7例中3例为同步放化疗,3例为单一放疗,1例为姑息治疗.A组存活1人,放疗后局部症状缓解率46%(6/13),平均生存时间5.07个月;其中放疗剂量小于45 Gy的病人有10例,平均存活时间为4.33个月;放疗剂量≥45 Gy者3例,平均存活时间为7.33个月.B组存活3例,治疗后疼痛缓解率为81%(22/27),平均存活6.65个月,其中放疗剂量小于45 Gy的有11例,平均存活时间为4.36个月;放疗剂量≥45 Gy者16例,平均存活时间为8.33个月.C组存活3例,治疗后疼痛缓解率为89%(8/9),放疔后平均存活9.89个月,其中放疗剂量小于45 Gy的有1例,存活时间为3个月;放疗剂量≥45 Gy者8例,平均存活时间为10.73个月.结论 三维适形放疗对晚期胰腺癌有姑息治疗的作用,疗效与治疗方式的选择、放疗剂量、病变累及范围和病人一般状态密切相关.对于部分晚期胰腺癌病人,采用积极同步放化三维适形放疗可获得较长的生存时间.  相似文献   

12.
Postoperative complications were investigated in 72 patients who received neoadjuvant therapy with esophagectomy. Preoperative chemotherapy consisted of 5-fluorouracil (700 mg/m2/day, on days 1 to 5), cisplatinum (70 mg/m2/day, on day 1) and leucovorin (20 mg/m2/day, on days 1 to 5). Preoperative chemoradiotherapy consisted of cisplatinum combined chemotherapy and radiotherapy (total dosage of 30-70 Gy). The incidence of postoperative pneumonia (16%) and anastomotic leakage (24%) in the preoperative chemotherapy group was slightly higher than that in the control group (n = 506), and mortality (6.0%) after esophagectomy in the preoperative chemotherapy group was higher than that (2.4%) of the control group. Postoperative morbidity and mortality were observed more frequently in patients who received two cycles of the chemotherapy than those receiving only one cycle. Postoperative complications occurred more frequently in patients suffering high grade toxicities due to the preoperative chemotherapy. The highest preoperative serum creatinine value correlated to that of postoperative period (r = 0.6494). The use of the preoperative chemoradiotherapy with a total exposure dosage of 60 Gy or more significantly increased the postoperative pneumonia rate (67%; p < 0.05) compared to the group receiving 40 Gy or less. The mortality rate (33%) also increased. The second cycle of the preoperative chemotherapy should be cancelled if patients suffer high grade toxicities during or after the first cycle, and the total exposure dosage of the preoperative chemoradiotherapy should be limited to 40 Gy or less.  相似文献   

13.
Postoperative complications were investigated in 72 patients who received neoadjuvant therapy with esophagectomy. Preoperative chemotherapy consisted of 5-fluorouracil (700 mg/m2/day, on days 1 to 5), cisplatinum (70 mg/m2/day, on day 1), and leucovorin (20 mg/m2/day, on days 1 to 5). Preoperative chemoradiotherapy consisted of cisplatinum combined chemotherapy and radiotherapy (total dosage of 30–70 Gy). The incidence of postoperative pneumonia (16%) and anastomotic leakage (24%) in the preoperative chemotherapy group was slightly higher than that in the control group (n = 506), and mortality (6.0%) after esophagectomy in the preoperative chemotherapy group was higher than that (2.4%) of the control group. Postoperative morbidity and mortality were observed more frequently in patients who received two cycles of the chemotherapy than those receiving only one cycle. Postoperative complications occurred more frequently in patients suffering high grade toxicities due to the preoperative chemotherapy. The highest preoperative serum creatinine value correlated to that of postoperative period (r = 0.6494). The use of the preoperative chemoradiotherapy with a total exposure dosage of 60 Gy or more significantly increased the postoperative pneumonia rate (67%; p < 0.05) compared to the group receiving 40 Gy or less. The mortality rate (33%) also increased. The second cycle of the preoperative chemotherapy should be cancelled if patients suffer high grade toxicities during or after the first cycle, and the total exposure dosage of the preoperative chemoradio-therapy should be limited to 40 Gy or less.  相似文献   

14.
Background: The goals of this study were to assess the feasibility and toxicity of a regimen of preoperative chemoradiotherapy, surgery, and intraoperative radiotherapy in the treatment of patients with potentially resectable gastric cancer. A secondary objective was to assess pathologic response to chemoradiotherapy in the treated tumors.Methods: Twenty-four patients were entered in the protocol. Treatment regimen consisted of 45 Gy of external beam radiotherapy with concurrent 5-FU given as a continuous infusion at a dose of 300 mg/m2. Patients were restaged 4–6 weeks after chemoradiotherapy and then underwent surgical resection and intraoperative radiotherapy to a dose of 10 Gy.Results: Twenty-three patients (96%) completed chemoradiotherapy in accordance with the study protocol. Nineteen (83%) of 23 patients who completed chemoradiotherapy underwent surgical resection with D2 lymphadenectomy. Four patients (17%) had progressive disease and were not resected. The morbidity and mortality rates were 32% and 5%, respectively. Of the resected patients, two (11%) had complete pathologic responses while 12 (63%) had pathologic evidence of significant treatment effect.Conclusions: Preoperative chemoradiotherapy for gastric cancer can be delivered safely and is well tolerated. The rate of surgical complications is consistent with that of other recently reported prospective trials of gastrectomy alone. Preoperative chemoradiotherapy resulted in significant pathologic responses in the majority of treated tumors, and complete pathologic responses were achieved in some patients.  相似文献   

15.
We reviewed salvage surgery cases for esophageal cancer following radical chemoradiotherapy. From January 1998 through January 2001, 6 patients (4 men, 2 women) underwent salvage operation at our department. Mean age was 56 years (range: 46-66). According to the Japanese Society for Esophageal Diseases localization schema, there was one case in the upper third of the thoracic esophagus, 3 cases in the middle third and 2 cases in the lower third. The histology was squamous cell carcinoma in all cases. Our radical chemoradiotherapy regimen for esophageal cancer was fluorouracil (5-FU) 400 mg/m2/24 hours i.v. on days 1 to 5 and 8 to 12, cisplatin (CDDP) 40 mg/m2/2 hours i.v. on days 1 and 8, and concurrent radiation therapy (2 Gy/day on days 1 to 5, 8 to 12 and 15 to 19). This regimen was repeated in 5 weeks, followed by 5-FU 800 mg/m2/24 hours i.v. on days 1 to 5 and CDDP 80 mg/m2/2 hours i.v. on day 1, which was repeated in 4 weeks. After these chemoradiotherapy, patients who were confirmed to have local recurrence or esophagobronchial fistula underwent salvage operation. Postoperative complications were anastomosis leakage in 1 patient, and anastomosis stenosis in 2 and esophagobronchial fistula in 1. Although no postoperative hospitalized death occurred, 1 patient died because of empyema 3 months after salvage operation. Another patient died due to respiratory failure 15 months later. The salvage operation outcomes are not acceptable. Salvage procedure and indication for salvage intervention need to be changed.  相似文献   

16.
目的 探讨体重指数(BMI)与体外冲击波碎石术(ESWL)术后常见并发症的关系。方法 选取2020年1月至2020年12本院收治的213例因肾结石需行ESWL治疗的患者,按《中国成人超重和肥胖症预防控制指南》分为A组(58例,BMI<18.5 kg/m2)、B组(120例,18.5 kg/m2≤BMI<24 kg/m2)、C组(35例,BMI≥24 kg/m2)。比较三组患者术前1 d和术后第1天的血肌酐和血中性粒细胞明胶酶相关脂质运载蛋白(NGAL),术后第1天复查泌尿系B超,按Clavien-Dindo分级对各组术后并发症进行评分并进行比较。结果 213例患者的碎石能量为(95.4±15.1)J,冲击次数为(1 230±310)次,碎石时间(21.6±10.2)min。与术前1 d相比,三组术后1 d的NGAL升高,差异有统计学意义(P<0.05)。 与C 组相比,A、B组术后1 d的血肌酐、NGAL升高,差异均有统计学意义(均P<0.05);与B组相比,A组术后1 d的血肌酐、NGAL升高,差异均有统计学意义(均P<0.05)。A组出现Clavien Ⅰ级并发症者8例、Clavien Ⅱ级并发症者4例,Clavien Ⅲ级并发症者1例;B组出现Clavien Ⅰ级并发症者6例、Clavien Ⅱ级并发症者2例,C组出现Clavien Ⅰ级并发症者2例,三组并发症比较,差异有统计学意义(P<0.05)。结论 BMI对于肾结石ESWL术后出现并发症有一定影响,BMI越低出现术后常见并发症概率越大。  相似文献   

17.
目的 探讨新辅助化放疗对局部进展期直肠癌低位前切除术后吻合13愈合的影响.方法 收集2001年5月至2007年8月的低位直肠癌(距肛缘≤6 cm)患者192例.全部病例均经术前化放疗.放疗40~46 Gy/20~23次,每周5次,每次2 Gy.放疗结束后休息六周.放疗同时进行化疗,口服卡培他滨1250 mg/(m~2·d),每日2次口服,直至手术.手术遵循TME原则进行.分析低位直肠癌术后吻合口漏发生情况.结果 全部病例完成术前化放疗.17例术前复查肿瘤完全消失(8.9%),未再进行手术治疗.手术前复查无一例发现肿瘤有进一步发展或转移.24例术后病理提示肿瘤完全消失,故肿瘤完全消失者共41例(21.4%).175例患者均按TME原则进行直肠癌根治术.保肛手术166例,保肛率为95.3%.其中低位直肠癌前切除术(LAR,双吻合器)134例,Parks术32例.腹会阴切除术6例.Hartmann术3例.在所有保肛患者中,发生吻合口漏9例,发生率为5.1%.LAR(双吻合器)术后发生吻合口漏6例,发生率为4.4%,其中直肠阴道漏4例.Parks术后吻合口漏3例,发生率为9.4%,其中直肠阴道漏1例.两组保肛手术吻合口漏发生率无显著差异(P>0.05).吻合口漏发生时间为术后2~10 d,均经相应处理后获得良好结果 .结论 合理运用新辅助化放疗不会明显增加低位直肠癌术后吻合口漏的发生.  相似文献   

18.
直肠癌患者术前联合放疗化疗与单纯放疗的疗效比较   总被引:2,自引:0,他引:2  
目的 探讨联合放化疗与单纯放疗对中低位局部进展期直肠癌疗效的影响.方法 回顾性分析北京协和医院1997年10月至2007年10月问69例中低位直肠癌患者在予以新辅助治疗后施行根治性手术治疗的临床资料.结果 术前单纯予以放疗者40例,放化疗联合者29例.全组患者肿瘤距肛缘3~10(平均5)cm.施行腹会阴联合切除术26例,低位前切除术27例,Parks术10例,Hartmann术6例;保肛率53.6%(37/69),其中单纯放疗组为47.5%(19/40),联合放化疗组为62.1%(18/29);两组比较差异无统计学意义(x2=1.435,P>0.05).29例患者肿瘤分期降低,其中联合放化疗组降期率58.6%(17/29),单纯放疗组30.0%(12/40),两组比较差异有统计学意义(x2=5.65,P<0.05).术后病理显示肿瘤完全消退(CR)7例,其中联合放化疗组4例(13.8%),单纯放疗组3例(7.5%);肿瘤部分缓解(PR)40例,其中联合放化疗组19例(65.5%),单纯放疗组21例(52.5%);无效(NR)22例,其中联合放化疗组6例(20.7%),单纯放疗组16例(40.0%);总有效率(CR加PR)68.1%(47/69),其中联合放化疗组为79.3%(23/29),单纯放疗组为60.0%(24/40);两组比较差异无统计学意义(x2=2.89.P>0.05).全组3年无病生存率77.3%.结论 联合放化疗应用于直肠癌新辅助治疗在肿瘤降期和缓解率方面优于单纯放疗组,直肠癌新辅助治疗中应联合应用放化疗.  相似文献   

19.
为对比分析DukesC期直肠癌患者行腹会阴联合切除术(Miles术)后同步放化疗与单纯化疗的疗效,本研究统计符合条件的临床病例132例,其中54例术后予以单纯化疗,78例术后予以同步放化疗。化疗方案:奥沙利铂130mg/m^2,d1;亚叶酸钙100mg/m^2,d1-5;氟尿嘧啶350mg/m^2,d1-5;每月化疗1次,连续化疗6个月。放射治疗方法:术后放射治疗定位采用CT模拟机,应用15MVX线,1.8Gy/次,4次/周,共7周,总剂量为50.4Gy。随访5年,观察患者局部复发、远处转移和5年生存情况。结果显示,(1)局部复发:单纯化疗组12例(22.22%),同步放化疗组6例(7.69%),两组局部复发率差异有统计学意义,P〈0.05。(2)远处转移:单纯化疗组28例(51.85%),同步放化疗组37例(47.44%),两组远处转移率差异无统计学意义,P〉0.05。(3)5年生存情况:单纯化疗组16例(29.63%),同步放化疗组37例(47.44%),两组5年生存率差异有统计学意义,P〈0.05。结果表明,DukesC期直肠癌患者Miles术后行同步放化疗,与单纯化疗相比,局部复发率降低,5年生存率升高,远处转移率相近。  相似文献   

20.

Background

A surgical resection is currently the preferred treatment for esophageal cancer if the tumor is considered to be resectable without evidence of distant metastases (cT1-3 N0-1 M0). A high percentage of irradical resections is reported in studies using neoadjuvant chemotherapy followed by surgery versus surgery alone and in trials in which patients are treated with surgery alone. Improvement of locoregional control by using neoadjuvant chemoradiotherapy might therefore improve the prognosis in these patients. We previously reported that after neoadjuvant chemoradiotherapy with weekly administrations of Carboplatin and Paclitaxel combined with concurrent radiotherapy nearly always a complete R0-resection could be performed. The concept that this neoadjuvant chemoradiotherapy regimen improves overall survival has, however, to be proven in a randomized phase III trial.

Methods/design

The CROSS trial is a multicenter, randomized phase III, clinical trial. The study compares neoadjuvant chemoradiotherapy followed by surgery with surgery alone in patients with potentially curable esophageal cancer, with inclusion of 175 patients per arm. The objectives of the CROSS trial are to compare median survival rates and quality of life (before, during and after treatment), pathological responses, progression free survival, the number of R0 resections, treatment toxicity and costs between patients treated with neoadjuvant chemoradiotherapy followed by surgery with surgery alone for surgically resectable esophageal adenocarcinoma or squamous cell carcinoma. Over a 5 week period concurrent chemoradiotherapy will be applied on an outpatient basis. Paclitaxel (50 mg/m2) and Carboplatin (Area-Under-Curve = 2) are administered by i.v. infusion on days 1, 8, 15, 22, and 29. External beam radiation with a total dose of 41.4 Gy is given in 23 fractions of 1.8 Gy, 5 fractions a week. After completion of the protocol, patients will be followed up every 3 months for the first year, every 6 months for the second year, and then at the end of each year until 5 years after treatment. Quality of life questionnaires will be filled out during the first year of follow-up.

Discussion

This study will contribute to the evidence on any benefits of neoadjuvant treatment in esophageal cancer patients using a promising chemoradiotherapy regimen.

Trial registration

ISRCTN80832026  相似文献   

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