A Phase III, Randomized Trial of Weekly Cisplatin and Radiation Versus Cisplatin and Tirapazamine and Radiation in Stage IB2, IIA, IIIB and IVA Cervical Carcinoma Limited to the Pelvis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 402
- 试验地点
- 281
- 主要终点
- Progression-free Survival - Percentage of Patients Alive and Progression Free
研究概览
简要总结
This randomized phase III trial is studying cisplatin, radiation therapy, and tirapazamine to see how well they work compared to cisplatin and radiation therapy in treating patients with cervical cancer. Drugs used in chemotherapy, such as cisplatin and tirapazamine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Cisplatin and tirapazamine may make tumor cells more sensitive to radiation therapy. It is not yet known whether giving cisplatin together with radiation therapy is more effective with or without tirapazamine in treating cervical cancer.
详细描述
PRIMARY OBJECTIVE:
I. Compare the progression-free survival of patients with stage IB, IIA, IIB, IIIB, or IVA carcinoma of the cervix treated with cisplatin and radiotherapy with vs without tirapazamine.
SECONDARY OBJECTIVES:
I. Compare overall survival of patients treated with these regimens. II. Compare the toxicity of these regimens in these patients.
TERTIARY OBJECTIVES:
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the uterine cervix
- •Stage IB2, IIA, IIB, IIIB, or IVA disease
- •Stage IIA tumors must be > 4 cm
- •Primary, untreated disease
- •Negative, non-suspicious para-aortic nodes by lymphangiogram, CT scan, MRI, or lymphadenectomy
- •Must have been adequately clinically staged
- •Suitable for treatment with radical intent using concurrent chemotherapy and pelvic radiotherapy
- •No disease involvement of the lower third of the vagina regardless of stage (all stage IIIA, IIIB and IVA with lower one-third involvement)
- •No carcinoma of the cervical stump
- •Performance status - GOG 0-3
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •SGOT ≤ 3 times ULN
- •Alkaline phosphatase ≤ 3 times ULN
- •Creatinine ≤ ULN or calculated creatinine clearance ≥ 60mL/min
- •No New York Heart Association class III-IV heart failure
- •No history of myocardial infarction
- •No unstable angina
- •No uncontrolled hypertension
- •No pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No septicemia or severe infection
- •No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- •No prior hysterectomy or planned hysterectomy as part of initial cervix cancer therapy
- •No prior coronary artery bypass surgery
- •No prior cancer therapy that would preclude study treatment
- •No concurrent angina medication
- •No concurrent intensity-modulated radiotherapy
排除标准
- 未提供
研究组 & 干预措施
Arm I (cisplatin)
Patients receive cisplatin IV on days 1, 8, 15, 22, 29, and 36 (weeks 1-6).
干预措施: cisplatin (Drug)
Arm II (cisplatin, tirapazamine)
Patients receive tirapazamine IV over 2 hours on days 1, 8, 10, 12, 15, 22, 24, 26, and 29 and cisplatin IV over 1 hour on days 1, 15, and 29.
干预措施: cisplatin (Drug)
Arm II (cisplatin, tirapazamine)
Patients receive tirapazamine IV over 2 hours on days 1, 8, 10, 12, 15, 22, 24, 26, and 29 and cisplatin IV over 1 hour on days 1, 15, and 29.
干预措施: tirapazamine (Drug)
结局指标
主要结局
Progression-free Survival - Percentage of Patients Alive and Progression Free
时间窗: From study entry until first disease progression, death or date of last contact, up to 6 years
Patients' progression status based on clinical, radiological or pathological (histological) evidence of disease after study therapy. Progression includes any death without evidence of disease progression. Progression-free Survival (PFS) is defined as time in month from study enrollment to disease progression, death or date of last contact.
次要结局
- Adverse Events (Grade 3 or Higher) During Treatment Period(All Adverse Events (AEs) occuring during treatment and up to 30 days after stopping the study treatment are reported)
- Overall Survival(From study entry to death or last contact, up to 6 years)