Phase III Randomized Trial of Comparing CCRT vs. RT Alone for Cervical Cancer Patients Primarily Treated by Radiotherapy and With Clinically Defined Good-prognosis
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- As defined by clinical and radiological parameters, stage IB- IIB cervical cancer patients treated by cisplatin-based CCRT have greater toxicities but similar survival rate as those treated by RT alone
研究概览
简要总结
This phase III study is designed to examine if low-risk, as defined by clinical and radiological parameters, stage IB-IIB cervical cancer patients treated by cisplatin-based chemoradiation, which is a recommended method by today's standard, have greater toxicities but similar survival rate as those treated by radiotherapy (RT) alone. Patients will be primarily treated with radiotherapy with same protocol, but without concurrent chemotherapy in the control arm, and with weekly cisplatin (40 mg/M2) for 6 courses in the study arm. This study will be conducted at all branches of Chang Gung Memorial Hospital except Chia-I.
Patients will be randomized to either arm after stratification of risk factors. Each arm will recruit 104 patients who have no LN and systemic metastasis as defined by CT/MRI and FDG-PET. The primary end point is grade 3-5 late toxicities, and secondary end points are 1) recurrence free survival; 2) acute toxicity of treatments; 3) sites of recurrence; 4) quality of life; 5) total treatment time. It is expected to take 5 years to recruit enough case number.
详细描述
OBJECTIVES:
Primary Objectives:
•To examine if low-risk, as defined by clinical and radiological parameters, stage IB-IIB cervical cancer patients treated by cisplatin-based CCRT have greater toxicities but similar survival rate as those treated by RT alone.
Secondary Objectives:
•To conduct a translational research to find out the molecular markers associated with radiosensitivity and distant metastasis in cervical cancer patients.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pathologically confirmed squamous cell carcinoma of cervix
- •Clinical FIGO stage IB-IIB
- •Planned to be primarily treated by RT.
- •Age: 45 < age< 80
- •No enlarged pelvic or para-aortic LN shown in CT-MRI (by CT-MRI criteria) and positive LN in FDG-PET studies.
- •Patients must have adequate bone marrow, pulmonary, liver and renal function
- •The interval between RT and randomization is not greater than 6 weeks.
- •Performance status
- •Patients must have signed informed consent to participate this study
排除标准
- •Age ≧80 or <=45
- •Documented pelvic LN or extrapelvic metastases: para-aortic LN, lung, liver
- •LN-positive on PET scans.
- •General medical condition or attitude makes them unsuitable for cisplatin therapy.
- •Small cell carcinoma, adenocarcinoma or adeno-adenosquamous carcinoma.
- •Previous pre-RT chemotherapy or pelvic RT
研究组 & 干预措施
ciaplantin,cancer,survival
干预措施: Cisplatin (Drug)
结局指标
主要结局
As defined by clinical and radiological parameters, stage IB- IIB cervical cancer patients treated by cisplatin-based CCRT have greater toxicities but similar survival rate as those treated by RT alone
时间窗: 2012
次要结局
- To conduct a translational research to find out the molecular markers associated with radiosensitivity and distant metastasis in cervical cancer patients.(2013)