Maintenance Chemotherapy Versus Consolidative Radiotherapy Plus Maintenance Chemotherapy for Unresectable Metastatic Colorectal Cancer: A Randomized Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
This study is a randomized phase II trial of maintenance chemotherapy versus consolidative radiotherapy plus maintenance chemotherapy for patients with unresectable metastatic colorectal cancer (MCRC).
详细描述
Prior to accrual on the trial, patients with unresectable metastatic colorectal cancer will be treated with palliative chemotherapy. And patients who achieve a partial response or stable disease by imaging criteria will receive maintenance chemotherapy. In our study, these group patients will be randomized to maintenance chemotherapy or consolidative radiotherapy to all sites of disease (followed by maintenance chemotherapy at the medical oncologist's discretion). Choices of palliative and maintenance chemotherapy will be determined by the medical oncologist based on clinical appropriateness.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have biopsy proven unresectable MCRC.
- •Patients must have received induction chemotherapy for 3-6 months, and achieved stable disease or a partial response.
- •Age ≥ 18 years
- •Patients must have measurable disease at baseline.
- •Patients can have up to only 5 discrete active extracranial lesions (≤3 in the liver and ≤3 in the lung) identified by position-emission tomography (PET) scan and also seen on correlative plain film, CT scan, or MRI within 8 weeks prior to the initiation of radiotherapy.
- •Patients who previously received radiotherapy to the primary site will be ineligible if there is CT evidence of disease progression within the past 3 months.
- •Patients must have a Karnofsky Performance Scores (KPS) >60
- •Aspartate aminotransferase, alanine aminotransferase & Alkaline phosphates must be ≤ 2.5 times the upper limit of normal (ULN). Total bilirubin must be within the limit of normal.
- •Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm³.
- •Patients should have adequate renal function (serum creatinine ≤1.5 times the ULN).
- •Females of childbearing potential should have a negative pregnancy test.
- •Patients who would be receiving radiation for lung lesions who are known or suspected by the treating radiation oncologist to have compromised lung function must have a documented forced expiratory volume in 1 second (FEV1) ≥ 1 litre.
- •Patients must provide verbal and written informed consent to participate in the study.
- •Total bilirubin: within normal institutional limits
排除标准
- •Patients with either untreated brain metastases or brain metastases treated within the past three months are ineligible
- •Patients with serious, uncontrolled, concurrent infection(s).
- •Significant weight loss (>10%) in the prior 3 months.
- •Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cancers.
- •Patients with more than 5 discrete metastatic lesions.
- •Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
- •Unwillingness to participate or inability to comply with the protocol for the duration of the study.
- •Patients who are pregnant. Patients with reproductive capability will need to use adequate contraception during the time of participation in the study
研究组 & 干预措施
Maintenance chemotherapy
FDA approved drugs for the study population: Bevacizumab, Xeloda
干预措施: maintenance chemotherapy (Drug)
Radiotherapy
consolidative radiotherapy plus maintenance chemotherapy
干预措施: Consolidative Radiotherapy (Radiation)
结局指标
主要结局
Progression free survival
时间窗: 2 years
Evaluate the effect of consolidative radiotherapy with or without maintenance chemotherapy versus maintenance chemotherapy alone on progression free survival
次要结局
- Overall survival(5 years)
- Toxicities(2 years)
- Actuarial rate in-field local control(2 years)
研究者
Tao Zhang
Cancer Center
Wuhan Union Hospital, China