Randomized Controlled Trial Comparing Concurrent Chemoradiation Versus Concurrent Chemoradiation Followed by Adjuvant Chemotherapy in Locally Advanced Cervical Cancer Patients
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 500
- 试验地点
- 11
- 主要终点
- Progression-free survival
研究概览
简要总结
Data of survival benefit from adjuvant chemotherapy (ACT) after concurrent chemoradiation (CCRT) for locally advanced cervical cancer (LACC) are still limited and inconsistent. We will investigate if ACT has survival benefit over CCRT alone.
详细描述
Concurrent chemoradiation (CCRT) is the standard treatment for cervical cancer of FIGO stage IIB-IVA or so called locally advanced cervical cancer (LACC). However, failure rate after treatment is still as high as 30% to 40%.
This is a multi-center randomized controlled trial which evaluates whether adjuvant chemotherapy (ACT) after CCRT will improve treatment outcome comparing to CCRT alone.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years
- •Cervical cancer FIGO stage IIB-IVA
- •Histopathology of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma
- •ECOG performance status 0-2
- •No history of other cancer except basal cell carcinoma
- •Adequate bone marrow function (WBC > or = 3,000/mm3, granulocytes > or = 1,500/mm3, platelet count > or = 100,000/mm3)
- •Bilirubin < 1.5 folds, SGOT/ SGPT < 1.5 folds of normal limit, creatinine clearance > or = 40 mg/dl
- •Consent to participate
排除标准
- •Para-aortic lymph node enlargement > 1 cm or suspicious for cancer metastasis from CT or MRI
- •Adnexal mass from physical examination or imaging study
- •Chronic illnesses e.g. renal failure/ impairment, peripheral or central neuropathy, uncontrolled diabetes mellitus, or HIV infection.
- •Pregnancy or lactation
研究组 & 干预措施
Concurrent chemoradiation
Radiation: Radiation Therapy
- External beam pelvic radiotherapy (45-50.4 Gy in 1.8 Gy fractions) delivered by Linear accelerator machine
- Vaginal brachytherapy for 4-5 fractions
Chemotherapy: Cisplatin
- Cisplatin 40 mg/m2 i.v., q wk, 6 cycles during radiotherapy
干预措施: Pelvic radiation (Radiation)
Concurrent chemoradiation
Radiation: Radiation Therapy
- External beam pelvic radiotherapy (45-50.4 Gy in 1.8 Gy fractions) delivered by Linear accelerator machine
- Vaginal brachytherapy for 4-5 fractions
Chemotherapy: Cisplatin
- Cisplatin 40 mg/m2 i.v., q wk, 6 cycles during radiotherapy
干预措施: Cisplatin (Drug)
Concurretn chemoradiation plus adjuvant chemotherapy
Radiation: Radiation Therapy
- External beam pelvic radiotherapy (45-50.4 Gy in 1.8 Gy fractions) delivered by Linear accelerator machine
- Vaginal brachytherapy for 4-5 fractions
Chemotherapy: Cisplatin, paclitaxel, carboplatin
- Cisplatin 40 mg/m2 i.v., q wk, 6 cycles during radiotherapy
- Paclitaxel 175 mg/m2 i.v. q 4 wks, 3 cycles starting 4 week after completion of CCRT
- Carboplatin AUC 5 i.v. q 4 wks, 3 cycles given together with paclitaxel
干预措施: Pelvic radiation (Radiation)
Concurretn chemoradiation plus adjuvant chemotherapy
Radiation: Radiation Therapy
- External beam pelvic radiotherapy (45-50.4 Gy in 1.8 Gy fractions) delivered by Linear accelerator machine
- Vaginal brachytherapy for 4-5 fractions
Chemotherapy: Cisplatin, paclitaxel, carboplatin
- Cisplatin 40 mg/m2 i.v., q wk, 6 cycles during radiotherapy
- Paclitaxel 175 mg/m2 i.v. q 4 wks, 3 cycles starting 4 week after completion of CCRT
- Carboplatin AUC 5 i.v. q 4 wks, 3 cycles given together with paclitaxel
干预措施: Cisplatin (Drug)
Concurretn chemoradiation plus adjuvant chemotherapy
Radiation: Radiation Therapy
- External beam pelvic radiotherapy (45-50.4 Gy in 1.8 Gy fractions) delivered by Linear accelerator machine
- Vaginal brachytherapy for 4-5 fractions
Chemotherapy: Cisplatin, paclitaxel, carboplatin
- Cisplatin 40 mg/m2 i.v., q wk, 6 cycles during radiotherapy
- Paclitaxel 175 mg/m2 i.v. q 4 wks, 3 cycles starting 4 week after completion of CCRT
- Carboplatin AUC 5 i.v. q 4 wks, 3 cycles given together with paclitaxel
干预措施: Paclitaxel (Drug)
Concurretn chemoradiation plus adjuvant chemotherapy
Radiation: Radiation Therapy
- External beam pelvic radiotherapy (45-50.4 Gy in 1.8 Gy fractions) delivered by Linear accelerator machine
- Vaginal brachytherapy for 4-5 fractions
Chemotherapy: Cisplatin, paclitaxel, carboplatin
- Cisplatin 40 mg/m2 i.v., q wk, 6 cycles during radiotherapy
- Paclitaxel 175 mg/m2 i.v. q 4 wks, 3 cycles starting 4 week after completion of CCRT
- Carboplatin AUC 5 i.v. q 4 wks, 3 cycles given together with paclitaxel
干预措施: Carboplatin (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 3 years
3-year progression free survival
次要结局
- Overall survival(3 years)
研究者
Siriwan Tangjitgamol, MD
Doctor
Navamindradhiraj University