Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated With Initial Radical Hysterectomy and Pelvic Lymphadenectomy (NCT #01101451)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 340
- 试验地点
- 716
- 主要终点
- Recurrence-free Survival (RFS) Rate at 3-years
研究概览
简要总结
This randomized phase III trial studies radiation therapy with chemotherapy to see how well they work compared to radiation therapy alone in treating patients with stage I-IIA cervical cancer who previously underwent surgery. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving radiation therapy together with chemotherapy is more effective than radiation therapy alone in treating patients with cervical cancer.
详细描述
PRIMARY OBJECTIVE:
I. To determine if post-operative adjuvant chemo-radiation therapy (CRT) can significantly improve recurrence-free survival (RFS) when compared to radiation therapy (RT) alone in stage I-IIA cervical cancer patients with intermediate-risk factors after treatment with radical hysterectomy.
SECONDARY OBJECTIVES:
I. To determine whether post-operative adjuvant CRT can improve overall survival (OS) when compared to RT alone in stage I-IIA cervical cancer patients with intermediate risk factors after treatment with radical hysterectomy.
II. To assess differences (across treatment arms) in incidence and severity of therapy attributed adverse events utilizing the active version of Common Terminology Criteria for Adverse Events (CTCAE).
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
- •Pathologically proven primary cervical cancer I-IIA with squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma initially treated with a standard radical hysterectomy with pelvic lymphadenectomy
- •Patients with the following characteristics (depth of stromal invasion and lymphovascular space involvement to be pathologically confirmed):
- •Positive capillary-lymphovascular space involvement and one of the following:
- •Deep third penetration
- •Middle third penetration, clinical tumor >= 2 cm
- •Superficial third penetration, clinical tumor >= 5 cm
- •Negative capillary-lymphatic space involvement
- •Middle or deep third penetration, clinical tumor >= 4 cm
- •Absolute neutrophil count (ANC) >= 1,500/mcl
- •Platelets >= 100,000/mcl
- •Creatinine =< upper limit of normal (ULN) or calculated creatinine clearance >= 60 mL/min
- •Bilirubin =< 1.5 x normal
- •Alkaline phosphate =< 3 x normal
- •Serum glutamic oxaloacetic transaminase (SGOT) =< 3 x normal
- •Gynecologic Oncology Group (GOG) performance status 0, 1, 2
- •Patients should not be randomized less than 3 weeks post-surgery but will not be acceptable for randomization more than 8 weeks post-surgery
- •Patients who have met the pre-entry requirements
- •Patients must have signed an approved informed consent and authorization permitting release of personal health information
排除标准
- •Patients with tumor in the parametria, pelvic lymph nodes or any other extra uterine site or with positive surgical margins
- •Patients with septicemia or severe infection
- •Patients with intestinal obstruction or gastrointestinal bleeding
- •Patients with postoperative fistula
- •Patients with cervix cancer who have received any previous radiation or chemotherapy
- •Patients whose circumstances do not permit completion of the study or the required follow-up
- •Patients with renal abnormalities requiring modification of radiation field (pelvic kidney, renal transplant, etc.)
- •Patients with GOG performance status of 3 or 4
- •Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
研究组 & 干预措施
Arm I (EBRT, IMRT)
Patients undergo pelvic EBRT or IMRT once daily, 5 days a week, for 5.5 weeks.
干预措施: External Beam Radiation Therapy (Radiation)
Arm I (EBRT, IMRT)
Patients undergo pelvic EBRT or IMRT once daily, 5 days a week, for 5.5 weeks.
干预措施: Intensity-Modulated Radiation Therapy (Radiation)
Arm I (EBRT, IMRT)
Patients undergo pelvic EBRT or IMRT once daily, 5 days a week, for 5.5 weeks.
干预措施: Laboratory Biomarker Analysis (Other)
Arm I (EBRT, IMRT)
Patients undergo pelvic EBRT or IMRT once daily, 5 days a week, for 5.5 weeks.
干预措施: Quality-of-Life Assessment (Other)
Arm I (EBRT, IMRT)
Patients undergo pelvic EBRT or IMRT once daily, 5 days a week, for 5.5 weeks.
干预措施: Questionnaire Administration (Other)
Arm II (cisplatin, EBRT, IMRT)
Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in Arm I. Treatment with cisplatin repeats every 7 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Cisplatin (Drug)
Arm II (cisplatin, EBRT, IMRT)
Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in Arm I. Treatment with cisplatin repeats every 7 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: External Beam Radiation Therapy (Radiation)
Arm II (cisplatin, EBRT, IMRT)
Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in Arm I. Treatment with cisplatin repeats every 7 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Intensity-Modulated Radiation Therapy (Radiation)
Arm II (cisplatin, EBRT, IMRT)
Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in Arm I. Treatment with cisplatin repeats every 7 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Laboratory Biomarker Analysis (Other)
Arm II (cisplatin, EBRT, IMRT)
Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in Arm I. Treatment with cisplatin repeats every 7 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Quality-of-Life Assessment (Other)
Arm II (cisplatin, EBRT, IMRT)
Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in Arm I. Treatment with cisplatin repeats every 7 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Recurrence-free Survival (RFS) Rate at 3-years
时间窗: 3 years from randomization
Estimate for probability of RFS at 3 years using Kaplan-Meier method, where RFS is defined as time from protocol registration (and randomization) to the date of first documented recurrence, death, or the date of last contact, whichever occurs first. Patients without recurrence or death were censored at the date of last contact.
次要结局
- Overall Survival (OS) Rate at 3-years(3 years from randomization)
- Number of Participants With Adverse Events (Grade 3 or Higher) During Treatment Period.(During treatment period and up to 21 days after stopping the study treatment. The median treatment duration was 39 days.)
- Patient Risk-benefit(up to 11 years)
- Quality of Life (QOL) as Measured With the FACT-Cx TOI(1. Pre-treatment (baseline), 2. 3 weeks following the first day of treatment, 3. 7 weeks following the first day of treatment, 4. 36 weeks following the first day of treatment.)