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临床试验/NCT01000415
NCT01000415Unknown3 期

Comparing Standard Concurrent Chemo-radiation to Neoadjuvant Chemotherapy Then Surgery or Radiation in Patients Stage Ib2-early IIb Cervical Carcinoma

Thai Gynecologic Oncology Collaborative Group2 个研究点 分布在 1 个国家目标入组 824 人开始时间: 2009年6月1日最近更新:
适应症

试验速览

阶段
3 期
发起方
入组人数
824
试验地点
2
主要终点
Overall survival comparison between experimental treatment group and standard treatment group

研究概览

简要总结

The purpose of this study is:

  • to compare the effectiveness between the new strategy of treatment (given cis-platinum plus gemcitabine-neoadjuvant chemotherapy followed by surgery),and standard treatment (given cis-platinum/carboplatin during radiation-concurrent chemoradiation)in specific group of cervical cancer patients (stage Ib2-early IIb)
  • to evaluate quality of life in both group of patients(standard treatment vs.experimental group)

详细描述

According to FIGO classification of cervical cancer, stage Ib2 was classified as clinically visible lesion more than 4.0 cm in greatest dimension and stage IIb was classified tumor invades parametrium must not to pelvic wall. These were the common stages in Thai cervical cancer patients,and made a troublesome effect to Thai women. According to this study,stage early IIb with 1/3 of parametrium involvement. Mostly these two stage was treated with concurrent chemoradiation, challenging the possibility of late sequelae of radiation effect. This specific group of patients can be avoid the referred side effect by using neoadjuvant chemotherapy followed by radical hysterectomy with pelvic lymphadenectomy and para-aortic node sampling in operable cases (at least partial response- PR) and concurrent chemoradiation (CCR) in inoperable cases (less than PR). Due to high risk type of these subspecific group, combination chemotherapy instead of single chemotherapy was used as CCR. However in operable cases with identified poor prognostic factor should be receive post operative radiation as the usual manner.

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 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Cervical cancer patients with FIGO stage Ib2-early IIb
  • Pathological proven squamous cell carcinoma or adenocarcinoma or adenosquamous cell carcinoma
  • ECOG performance status 0-1
  • No previous treatment for cervical cancer
  • Acceptable hematological,renal,liver function

排除标准

  • Previous history of cancer
  • Underlying disease not fit for surgery
  • Psychological problem
  • Obvious pelvic/para-aortic node involvement
  • Pregnancy
  • HIV positive
  • History of bowel obstruction

结局指标

主要结局

Overall survival comparison between experimental treatment group and standard treatment group

时间窗: 9 Years

次要结局

  • Comparing disease free survival between experimental treatment group and standard treatment group(9 years)

研究者

发起方
Thai Gynecologic Oncology Collaborative Group
申办方类型
Network

研究点 (2)

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