Phase I Study of Preoperative Concurrent Chemo-radiation With Capecitabine in Elderly Rectal Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of Participants Experienced Dose Limited Toxicity
研究概览
简要总结
This phase I study is designed to determine the maximum tolerant dose of capecitabine when used in preoperative concurrent chemo-radiation for locally advanced rectal patients over 75 years old.
详细描述
It is proved that preoperative concurrent chemo-radiotherapy can improve both local control and overall survival in stage II/III rectal cancer patients. But elderly patients, especially patients over 75 years were hardly involved in related clinical trials considered of their fragility.
Several retrospective study showed that old rectal cancer patients would also benefit from concurrent chemo-radiation, with acceptable toxicity. Several new drug, such as capecitabine, also seem to be safety for elderly cancer patients. But few prospective study has been carried out.
The investigators designed this phase I study, to explore the maximum tolerant dose of capecitabine in preoperative concurrent chemoradiation for elderly stage II/III rectal cancer patients, as well as to evaluate safety.
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •rectal adenocarcinoma, clinical stage II/III(T3-4 or N+, AJCC 7th).
- •KPS status no less than 70; Charlson comorbidity no more than
- •life expectancy more than 6 months.
- •hemoglobin >= 100g/L, white blood cell >= 3.5*10E9/L, neutrophil >= 1.5*10E9/L, platelet >= 100*10E9/L.Creatin normal, Total bilirubin normal, AST and AST normal, AKP normal.
- •do not have allergy history to thymidine phosphorylase.
- •do not receive surgery ( except palliative colostomy) or chemotherapy or other anti-cancer treatment
- •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
- •previous pelvic irradiation history
- •receiving surgery (except palliative colostomy), chemotherapy or other anti-cancer treatment
- •allergy history to thymidine phosphorylase
- •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.
- •anticipate other clinical trials in four weeks before enrollment
研究组 & 干预措施
1000mg
capecitabine 1000mg/m2/d d1-14, d22-25 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)
1350mg
capecitabine 1300mg/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)
1650mg
capecitabine 1650mg/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
Number of Participants Experienced Dose Limited Toxicity
时间窗: up to 7 weeks from start of the treatment
Dose related toxicity is defined as follows:1. luecopenia \> grade 2; granular cell decrease \> grade 2; anemia \> grade 1; platelet \> grade 1;SGPT/SGOT elevation \> grade 1; ALP \> grade 1; GGT \> grade 1; Tbil \> grade 1;renal function damag \> grade 2;Non-gradular cell decreased fever \> grade 1;nausea/vomiting \> grade 1; fatigue \> grade 2; weight loss \> grade 2;gastritis \> grade 2; dairrea \> grade 2; abdominal pain \> grade 2; upper gastrointestinal bleeding \> grade 1;other toxic reaction \> grade 2;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