Concurrent Chemoradiotherapy With Weekly Cisplatin Versus Concurrent Chemoradiotherapy With Weekly Cisplatin and Paclitaxel in Locally Advanced Carcinoma Cervix
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- clinical response of the disease
研究概览
简要总结
The purpose of this study is to check whether addition of paclitaxel to cisplatin and radiation therapy will improve the outcome in locally advanced carcinoma cervix.
详细描述
Carcinoma cervix is the 2nd most common malignancy among females and about 86% of this burden occurs in developing countries. India accounts for 27% of world cervical cancer burden; and most of them are of locally advanced stage ie stage IIA to IVA.
Significant development in radiation techniques and addition of cisplatin based chemotherapy to radiation schedule has led to improved survival but still it is far from satisfactory with 20 to 25% patients failing locally while 10 to 20% patients fail at distant sites. Novel techniques are required to improve this dismal rate.
Thus investigators intended to use combination chemotherapy with paclitaxel and cisplatin, considering that paclitaxel is a taxane which has shown good efficacy in other solid tumors such as ovary, lung and breast; it has also shown radiosensitizing effect in cervical cancer cell lines and it has also been shown to be effective in phase III trials with cisplatin in metastatic and recurrent carcinoma cervix.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •histologically proven carcinoma cervix
- •age 18 years to 65 years
- •stage IIA, IIB, IIIA & IIIB according to FIGO 2009
排除标准
- •age > 65 years and < 18 years
- •stage IA, IB, IVA & IVB
- •Histology other than squamous cell, adenocarcinoma or adenosquamous carcinoma
- •history of prior pelvic surgery for cancer, prior pelvic radiotherapy or prior chemotherapy.
- •deranged renal function test and liver function test
- •KPS >= 60
- •distant metastasis
研究组 & 干预措施
cisplatin and paclitaxel with concurrent radiotherapy
weekly cisplatin at 30mg/m2 and paclitaxel at 50mg/m2 are given with concurrent radiotherapy at 2Gy per fraction at 5 fractions per week for 5 weeks followed by either low dose rate (LDR) Intracavitary (I/C) Brachytherapy or supplement Chemoradiotherapy (CRT); if not fit for I/C Brachytherapy
干预措施: Paclitaxel, Cisplatin (Drug)
cisplatin with concurrent radiotherapy
weekly cisplatin @ 40mg/m2 is given along with concurrent radiotherapy at 2Gy per fraction with 5 fractions per week for 5 weeks followed by LDR I/C brachytherapy or supplement CRT; if not fit for I/C Brachytherapy
干预措施: Cisplatin (Drug)
结局指标
主要结局
clinical response of the disease
时间窗: up to 1 year
to compare clinically, the disease response and local control of combination chemotherapy with weekly cisplatin and paclitaxel with concurrent Radiotherapy Vs single agent cisplatin with concurrent Radiotherapy in locally advanced carcinoma cervix
次要结局
- number of patients with adverse events(during treatment, 14 weeks)
研究者
Dr Pragyat Thakur
Junior Resident, department of radiotherapy, Principal Investigator
Indira Gandhi Medical College, Shimla