Phase 3 Randomized Comparison of Concurrent Gemcitabine, Cisplatin, and Radiation Followed by Adjuvant Gemcitabine and Cisplatin Versus Concurrent Cisplatin and Radiation in Cancer of the Cervix Stages IIB to IVA
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 515
- 试验地点
- 1
- 主要终点
- Number of Participants With Progressive Disease or Death Due to Any Cause at 3 Years
研究概览
简要总结
The purpose of this study is to compare the effectiveness of two methods of treating cancer of the cervix. Half the patients will receive gemcitabine plus cisplatin while undergoing radiation therapy, followed by adjuvant gemcitabine and cisplatin and the other half will receive cisplatin along with radiation therapy without adjuvant therapy.
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
- •diagnosed with cancer of cervix
- •tumor that can be measured
- •no previous treatment with chemotherapy or radiation for this cancer
- •Karnofsky Performance Status Score >=70
- •able to give written consent
- •willing and able to participate in the study, both during the active treatment and the follow-up period.
排除标准
- •impairment such as hearing loss from prior cisplatin therapy
- •damage to nerves such as being unable to distinguish hot and cold to touch
- •used other experimental medication in past 30 days
- •lab test results are not within the limits required for this study
- •pregnancy or breast-feeding or possibility of becoming pregnant during this study and not using an approved method of birth control.
研究组 & 干预措施
1
Cisplatin, 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks and Gemcitabine 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks and Pelvic radiation, 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
Two week rest period with no chemotherapy or radiation
Cisplatin, 50 mg/m2, intravenous (IV), day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles
干预措施: Gemcitabine (Drug)
1
Cisplatin, 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks and Gemcitabine 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks and Pelvic radiation, 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
Two week rest period with no chemotherapy or radiation
Cisplatin, 50 mg/m2, intravenous (IV), day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles
干预措施: Cisplatin (Drug)
1
Cisplatin, 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks and Gemcitabine 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks and Pelvic radiation, 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
Two week rest period with no chemotherapy or radiation
Cisplatin, 50 mg/m2, intravenous (IV), day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles
干预措施: Brachytherapy (Radiation)
1
Cisplatin, 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks and Gemcitabine 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks and Pelvic radiation, 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
Two week rest period with no chemotherapy or radiation
Cisplatin, 50 mg/m2, intravenous (IV), day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles
干预措施: Pelvic radiation (Radiation)
2
Cisplatin, 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks and Pelvic radiation, 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
干预措施: Cisplatin (Drug)
2
Cisplatin, 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks and Pelvic radiation, 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
干预措施: Brachytherapy (Radiation)
2
Cisplatin, 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks and Pelvic radiation, 1.8 Gy/day, 5 days/week, 6 weeks
Brachytherapy, 30-35 Gy over 1 week
干预措施: Pelvic radiation (Radiation)
结局指标
主要结局
Number of Participants With Progressive Disease or Death Due to Any Cause at 3 Years
时间窗: Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively
Original outcome was Progression-Free Survival (PFS) probability at 3 years. PFS=time from baseline to progressive disease (PD) or death from any cause. Probability is not an accepted "Measure Type", so number of progression-free patients still at risk and cumulative number of patients that had an event (PD or death of any cause) are presented.
次要结局
- Number of Participants With Progressive Disease or Death Due to Disease Under Study at Various Time Points(Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively)
- Local Failure Rate(Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively)
- Tumor Response(Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively)
- Number of Participants Who Died From Any Cause at Various Time Points(baseline to date of death from any cause (includes 60 month follow-up period))
- Number of Participants With Progressive Disease or Death Due to Any Cause at Various Time Points(Tumor assessments at baseline, weekly during chemoradiation & brachytherapy, on Day 1 of adjuvant Cycles 1&2 for Arm A, at the 30-day post-study visit, every 4/6 months for 12/48 months of the short/long post-study follow-up periods respectively)