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

Description

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.

Study Start Date

July 2014

Estimated Completion Date

July 2017

Interventions

  • Behavioral: Questionnaires
  • Radiation: endorectal brachytherapy
  • Drug: concurrent capecitabine or 5-FU

Specialties

  • Oncology: Colorectal Cancer/Polyps,Pharmacology/Therapy
  • Radiology: Radiotherapy (XRT)
  • Pharmacy: Chemotherapy/Oncology
  • Physician Assistant: Hematology/Oncology

MeSH Terms

  • Anus Neoplasms
  • Rectal or Anal Cancer

Study ID

Memorial Sloan-Kettering Cancer Center -- 14-104

Status

Unknown

Trial ID

NCT02199236

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

24

Sponsor

Memorial Sloan-Kettering Cancer Center

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (6)

Study Location Distance Name Phone Email
Memorial Sloan Kettering Cancer Center Suffolk - Commack, New York 26.2 miles Abraham Wu MD 212-639-5257 None
Memorial Sloan Kettering West Harrison - West Harrison, New York 28.7 miles Abraham Wu MD 212-639-5257 None
Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center - Sleepy Hollow, New York 33.0 miles Abraham Wu MD 212-639-5257 None
Memorial Sloan Kettering Cancer Center at Mercy Medical Center - Rockville Centre, New York 43.4 miles Abraham Wu MD 212-639-5257 None
Memorial Sloan Kettering Cancer Center - New York, New York 50.7 miles Abraham Wu MD 212-639-5257 None
Memorial Sloan Kettering Cancer Center at Basking Ridge - Basking Ridge, New Jersey 78.1 miles Abraham Wu MD 212-639-5257 None

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