Clinical Trial: 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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 U

Brief Summary: 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.

Detailed Summary:
Sponsor: Memorial Sloan Kettering Cancer Center

Current Primary Outcome: maximum tolerated dose (MTD) [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: tumor response [ Time Frame: 3, 6, and 12 months ]

MRI with DCE & DWI (unless contraindicated) after brachytherapy


Original Secondary Outcome: tumor response [ Time Frame: 3, 6, and 12 months ]

MRI Pelvis with DCE & DWI (unless contraindicated) after brachytherapy


Information By: Memorial Sloan Kettering Cancer Center

Dates:
Date Received: July 22, 2014
Date Started: July 2014
Date Completion:
Last Updated: January 11, 2017
Last Verified: January 2017