NCT01363466终止3 期
Randomized Phase III Trial Evaluating the Impact of Hysterectomy After Chemoradiation Therapy for Stage IB2/II Cervical Cancer
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- UNICANCER
- 入组人数
- 61
- 试验地点
- 70
- 主要终点
- Relapse free survival
研究概览
简要总结
GYNECO 02 hypothesis is that hysterectomy reduces the possibility of local or loco-regional relapse, especially in patient with a reduced metastatic risk and who received a local chemoradiation therapy with an increase of radiotherapy doses (45 grays).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •operable Stage IB2/II Cervical Cancer
- •adenocarcinoma, squamous cell or adenosquamous carcinoma
- •Patient between 18 and 70 years old
- •No lombo-aortic lymph node invasion at baseline
- •Previous 45 grays external pelvic radiation with concomitant chemotherapy (cisplatin 40 mg/m2/week corresponding to 5 cycles)
- •Followed by a 15 grays utero-vaginal brachytherapy, eventually combined with a 6th cycle of chemotherapy (cisplatin 40 mg/m2)
- •with a pelvic boost if lymph node or parametrial invasion
- •No macroscopic residual tumor after 6 to 8 weeks after brachytherapy.
排除标准
- •Other tumor histology (neuro-endocrine)
- •Stage > II (FIGO 1995) at baseline
- •Patient with remaining cervical cancer (after sub-total hysterectomy)
结局指标
主要结局
Relapse free survival
时间窗: from randomization to relapse or last contact (up to 3 years)
There is a follow-up period of 3 years.
次要结局
- Overall Survival(From randomisation to death or last contact (up to 3 years))
研究者
研究点 (70)
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