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子宫颈癌分疗程与连续盆腔照射的比较:放射治疗肿瘤学组的一项前瞻性随机临床试验

Split-course versus continuous pelvis irradiation in carcinoma of the uterine cervix: a prospective randomized clinical trial of the Radiation Therapy Oncology Group.

作者信息

Marcial V A, Amato D A, Marks R D, Rotman M, Canoy N, Figueroa-Vallés N F, Hanley J A

出版信息

Int J Radiat Oncol Biol Phys. 1983 Apr;9(4):431-6. doi: 10.1016/0360-3016(83)90058-5.

DOI:10.1016/0360-3016(83)90058-5
PMID:6406397
Abstract

In August 1980, the Radiation Therapy Oncology Group (RTOG) completed a prospective randomized clinical trial for the comparison of a split-course versus a standard continuous course of pelvic irradiation for carcinoma of the uterine cervix Stages II-B, III-A, III-B, and IV-A. The split-course consisted of 10 fractions of 250 rad each, 5 times a week, up to 2500 rad followed by a rest period of approximately 2 weeks and then another 2500 rad was given (250 X 10). The continuous course consisted of 30 fractions of 170 rad each, 5 times per week, for a total of 5100 rad. In both groups the external pelvis irradiation was followed by intracavitary brachytherapy in the uterus and vagina, with tandem-colpostat or tandem only, for a dose of 3000 rad at point A for the former, or at 2 cm from the center of the linear source for the latter. In cases where brachytherapy was not possible, a boost of external irradiation with reduced field, with a dose of 1600 rad (200 X 8) was advised. Three hundred and one patients were registered, of which 287 are currently evaluable. No differences between the treatments were detected for the following study end-points: treatment tolerance in terms of acute normal tissue reactions and completion of therapy, tumor control in the pelvis, severe late normal tissue reactions, and survival. In the entire study population the estimated tumor control in the pelvis at two years after initiation of therapy was: 81% for Stage II-B, 67% for III-A, 53% for Stage III-B, and 32% for Stage IV-A. The estimated two-year survival was: 70% for Stage II-B, 58% for III-A, 46% for III-B, and 23% for IV-A.

摘要

1980年8月,放射治疗肿瘤学组(RTOG)完成了一项前瞻性随机临床试验,以比较子宫颈癌II - B期、III - A期、III - B期和IV - A期患者盆腔照射的分段疗程与标准连续疗程。分段疗程包括每次250拉德,每周5次,共10次,剂量达2500拉德,随后休息约2周,然后再给予2500拉德(250×10)。连续疗程包括每次170拉德,每周5次,共30次,总剂量为5100拉德。两组患者在盆腔外照射后均进行子宫和阴道腔内近距离放疗,前者采用阴道塞子或仅用施源器,A点剂量为3000拉德,后者在线性源中心2厘米处给予相同剂量。在无法进行近距离放疗的情况下,建议缩小照射野进行外照射加强,剂量为1600拉德(200×8)。登记了301例患者,其中287例目前可进行评估。对于以下研究终点,未检测到治疗之间的差异:急性正常组织反应和治疗完成方面的治疗耐受性、盆腔肿瘤控制、严重晚期正常组织反应和生存率。在整个研究人群中,治疗开始后两年盆腔肿瘤控制的估计值为:II - B期81%,III - A期67%,III - B期53%,IV - A期32%。两年生存率的估计值为:II - B期70%,III - A期58%,III - B期46%,IV - A期23%。

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