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

Completed · Phase 1

Conditions studied: Rectal or Anal Cancer

In brief

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.

Key facts

Study ID

NCT02199236

Run by

Memorial Sloan Kettering Cancer Center

People needed

15

Starts

2014-07-01

Expected to finish

2024-10-29

Last updated by the study team

2024-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Memorial Sloan Kettering Basking Ridge (Follow Up Only) — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Monmouth (Follow Up Only) — Middletown, New Jersey, United States
• Memorial Sloan Kettering Commack (Consent and Follow up) — Commack, New York, United States
• Memorial Sloan Kettering Westchester (Follow Up Only) — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Rockville Center (Follow Up Only) — Rockville Centre, New York, United States
• Memorial Sloan Kettering Nassau (Follow-Up only) — Uniondale, New York, United States

Full record on ClinicalTrials.gov

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