Phase 1 Study of Postoperative Capecitabine With Concurrent Radiation in Elderly With Stage II/III Rectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Dose Related Toxicity
研究概览
简要总结
The purpose of this study is to seek the proper dose of capecitabine in post-operative concurrent chemotherapy for stage II/III elderly rectal cancer patients receiving radical surgery, and evaluate the toleration of this modality in such patients.
详细描述
For those "younger" locally advanced (stage II/III) rectal cancer patients (usually means patients less than 70), it is suggested that after radical surgery, patients should receive concurrent chemo-radiation. Capecitabine is a widely used chemotherapy medicine under such condition. Based on experience, the investigators think this modality can also be tolerated by patients over 70, and will increase local control rate as which has been proved in younger ones. As the first step to test this hypothesis, we designed this phase I study to seek the proper dose of capecitabine, a widely used oral chemotherapy medicine, in postoperative concurrent chemo-radiation for stage II/III rectal cancer patients over 70, and to evaluate the safety of this modality in this group of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 71 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •rectal adenocarcinoma, pathological stage II/III(T3-4 or N+, UICC 2002), radical surgery received.
- •interval between surgery and enrollment no less than two week and no more than 3 months.
- •KPS status no less than 70; life expectancy no less than 6 months.
- •without life-threatening complications, such as severe hypertension, coronary heart disease, cerebral vascular disease, uncontrolled diabetes, etc.
- •without severe drug allergy history.
- •hemoglobin >= 100g/L, white blood cell >= 3.5*10E9/L, neutrophil >= 1.5*10E9/L, platelet >= 100*10E9/L.
- •Creatin <= 1.5* ULN(upper limit of normal), Total bilirubin <= 2.5 ULN, AST and AST <= 2.5* ULN, AKP <= 2.5*ULN
- •do not receive chemotherapy before six months from enrollment.
- •no previously pelvic irradiation history
- •informed consent signed
排除标准
- •other cancer history, except curable non-melanoma skin cancer or cervix in-situ carcinoma
- •allergy history to thymidine phosphorylase
- •previous pelvic irradiation history
- •receiving adjuvant chemotherapy in six months before enrollment
- •active infection existed
- •severe complication, such as acute myocardial infarction in 6 months, uncontrolled diabetes ( Plasma glucose concentrations in any time of a day≥11.1mmol/L）, severe cardiac arrhythmia， etc.
- •life expectancy less than 6 months
- •estimated cannot finish treatment
- •attend other clinical trials in four weeks before enrollment
- •receive other anti-cancer treatment currently
- •other conditions which regarded illegal by censors with full reasons. for example, some conditions may conflict from the protocol.
研究组 & 干预措施
1000mg
capecitabine 1000mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
干预措施: Capecitabine (Drug)
1200mg
capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
干预措施: Capecitabine (Drug)
1400mg
capecitabine 1400mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
干预措施: Capecitabine (Drug)
1500mg
capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
干预措施: Capecitabine (Drug)
结局指标
主要结局
Dose Related Toxicity
时间窗: up to 9 weeks
dose related toxicity is defined as follows:1. WBC damage \>= grade 3; granular cell decrease \>= grade 3; hemoglobin \>= grade 2; platelet \>= grade 2;SGPT/SGOT elevation \>= grade 2; ALP \>= grade 2; GGT \>= grade 2; Tbil \>= grade 2;renal function damage: BUN/Cr elevation \>= grade 2;Non-gradular cell decreased fever \>= grade 2;nausea/vomiting \>= grade 2; fatigue \>= grade 3; weight loss \>= grade 3;gastritis \>= grade 3; dairrea \>= grade 3; abdominal pain \>= grade 3; pancreatitis \>= grade 2; upper gastrointestinal bleeding \>= grade 2;other toxic reaction \>= grade 3;KPS \< 50 during the treatment
次要结局
未报告次要终点
研究者
Jing Jin, M.D.
vice chair of radiation department
Chinese Academy of Medical Sciences