Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Rate of Tumor Downstaging Compared With Historical Controls.
研究概览
简要总结
Determine if genotype-directed neoadjuvant chemoradiation, using information from the thymidylate synthase promoter polymorphism, result in a greater degree of tumor downstaging in high risk patients compared to historical controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven adenocarcinoma of the rectum
- •Lesion evaluated by surgeon and found to be resectable
- •Stage T3 or T4 disease on radiography or ultrasound
- •Karnofsky Performance Status at >60
- •Laboratory criteria:
- •Absolute neutrophil count >= 1.5 K
- •Platelets >= 100 K
- •Total Bilirubin <= 2.0;
- •SGOT and Alkaline Phosphatase <= 2 x upper limit of normal
- •Creatinine < 2.0
- •Informed consent signed
- •Patients with distant metastatic disease will be eligible if they satisfy all other conditions.
排除标准
- •Pregnant women, children < 18 years, or patients unable to give informed consent
- •Patients with a past history of pelvic radiotherapy.
- •Patients with prior malignancy in the past 5 years except: skin cancer or in-situ cervical cancer. However, patients with synchronous adenocarcinomas are eligible provided either (a) the synchronous adenocarcinoma was in a removed pedunculated polyp and did not invade the stalk or (b) the synchronous adenocarcinoma was in a removed polyp that lay within the surgical field (extent of resection would not be changed) or (c) the synchronous adenocarcinoma is smaller than the index rectal cancer and lies completely within the radiation field (clinically favorable second lesion and the extend of radiation and surgery would not be changed).
- •Patients with known allergy to 5-fluorouracil or irinotecan
研究组 & 干预措施
Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4)
Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable.
干预措施: 5FU (Drug)
Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4)
Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable.
干预措施: Radiation (Radiation)
Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4)
Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable.
干预措施: Surgery of resectable lesions (Procedure)
Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4)
Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Irinotecan 50 mg/m2 IV weekly for 5 doses.
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable.
干预措施: 5FU (Drug)
Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4)
Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Irinotecan 50 mg/m2 IV weekly for 5 doses.
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable.
干预措施: Radiation (Radiation)
Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4)
Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Irinotecan 50 mg/m2 IV weekly for 5 doses.
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable.
干预措施: Surgery of resectable lesions (Procedure)
Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4)
Radiation 45 Gy in 25 fractions to the pelvis.
5FU CIVI 225 mg/m2/day by CIVI during radiation
Irinotecan 50 mg/m2 IV weekly for 5 doses.
Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable.
干预措施: Irinotecan (Drug)
结局指标
主要结局
Rate of Tumor Downstaging Compared With Historical Controls.
时间窗: 1 year after enrollment
Tumor downstaging (DS) is defined as a decrease in the T stage of the primary tumor by at least 1. Historical studies demonstrate a DS rate of 45%.
次要结局
- Define Patient Quality of Life Prior to and Following Neoadjuvant Chemoradiation.(Prior to start of study treatment and 3-6 weeks post completion of radiation therapy)
- Determine Patient Fears and Expectations of Pharmacogenetics.(Prior to start of study treatment and 3-6 weeks post completion of radiation therapy)
- Complete Response Rates(1 year after enrollment)