A Phase I, Dose Escalation Trial of Endoluminal High Dose Rate Brachytherapy With Concurrent Chemotherapy for Rectal or Anal Cancer in Patients With Recurrent Disease or Undergoing Non-Operative Management
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 7
- 主要终点
- maximum tolerated dose (MTD)
研究概览
简要总结
The purpose of this study is to see what amount of radiation is safe to give to rectal or anal cancer patients who are being treated with a procedure called brachytherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically or cytologically confirmed locally residual or recurrent cancer of the rectum or anus
- •Prior pelvic EBRT
- •Age > or = to 18 years
- •ECOG performance status 0, 1, or 2
- •At least 4 weeks from prior major surgery or radiotherapy
- •Have undergone Surgical, Medical and Radiation Oncology evaluations to confirm :
- •Eligible for infusional 5-FU or capecitabine
- •Will not undergo surgery for the study disease
- •Able to receive HDR brachytherapy ANC ≥ 1.5 cells/mm3 and PLT ≥100,000/mm3
- •Adequate Renal function: Creatinine <1.5 x the upper limit of normal (ULN) or calculated creatinine clearance of ≥ 50cc/min
- •Adequate Hepatic functions: Bilirubin less than 1.5 mg/dL; (except in patients with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL)
- •AST or ALT <3xULN, or <5x ULN if known liver metastases
- •Normal Cardiac function:
- •No active coronary artery disease;
- •No New York Heart Association class II, III or IV disease;
- •No arrhythmia requiring treatment
- •Maximum tumor length of 7 cm at time of brachytherapy treatment start
排除标准
- •Women who are pregnant.
- •Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire treatment period and after receipt of brachytherapy. Male subjects must also agree to use effective contraception during the treatment period and until 1 year after the completion of brachytherapy.
- •Patients with any other concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this study.
- •Patients on concurrent anti-cancer therapy other than that allowed in the study.
- •Contraindications to general anesthesia
研究组 & 干预措施
endorectal brachytherapy, concurrent chemo and questionnaires
This is a phase I, dose-escalation study to evaluate the safety of endorectal brachytherapy with concurrent capecitabine or 5-fluoruracil (5-FU) in the management of locally recurrent/residual rectal or anal cancer in patients who have received pelvic external beam radiation therapy (EBRT) +/- chemotherapy. We will use magnetic resonance imaging (MRI) with dynamic contrast enhancement (DCE) and diffusion weighted imaging (DWI) series to contribute to the assessment of tumor response.
干预措施: endorectal brachytherapy (Radiation)
endorectal brachytherapy, concurrent chemo and questionnaires
This is a phase I, dose-escalation study to evaluate the safety of endorectal brachytherapy with concurrent capecitabine or 5-fluoruracil (5-FU) in the management of locally recurrent/residual rectal or anal cancer in patients who have received pelvic external beam radiation therapy (EBRT) +/- chemotherapy. We will use magnetic resonance imaging (MRI) with dynamic contrast enhancement (DCE) and diffusion weighted imaging (DWI) series to contribute to the assessment of tumor response.
干预措施: concurrent capecitabine or 5-FU (Drug)
endorectal brachytherapy, concurrent chemo and questionnaires
This is a phase I, dose-escalation study to evaluate the safety of endorectal brachytherapy with concurrent capecitabine or 5-fluoruracil (5-FU) in the management of locally recurrent/residual rectal or anal cancer in patients who have received pelvic external beam radiation therapy (EBRT) +/- chemotherapy. We will use magnetic resonance imaging (MRI) with dynamic contrast enhancement (DCE) and diffusion weighted imaging (DWI) series to contribute to the assessment of tumor response.
干预措施: Questionnaires (Behavioral)
结局指标
主要结局
maximum tolerated dose (MTD)
时间窗: 1 year
will employ a standard 3+3 dose-escalation scheme. Patients will be accrued to the study in cohorts of 3. An initial cohort of 3 patients will be treated to each dose. The dose level will be escalated if none of the 3 patients exhibits any DLT within 90 days of completion of brachytherapy. Dose escalation will not take place until every patient in the prior dose cohort has been monitored for 90 days.
次要结局
- tumor response(3, 6, and 12 months)