High-Dose-Rate Brachytherapy and Chemotherapy in Treating Patients with Locally Recurrent or Residual Rectal or Anal Cancer Undergoing Non-operative Management

Status: Active

Description

This phase I trial studies the side effects and best dose of high-dose-rate brachytherapy when given together with chemotherapy in treating patients with rectal or anal cancer that has come back or gotten worse and cannot be treated with surgery. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. High-dose-rate (HDR) brachytherapy uses the radioactive material to deliver a high radiation dose in a short period of time to the tumor. It may also send less radiation to nearby healthy tissues and may reduce the risk of side effects. Drugs used in chemotherapy, such as capecitabine and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving HDR brachytherapy together with capecitabine or fluorouracil may kill more tumor cells.

Eligibility Criteria

Inclusion Criteria

  • Histologically or cytologically confirmed locally residual or recurrent cancer of the rectum or anus
  • Prior pelvic external beam radiotherapy (EBRT)
  • Eastern Cooperative Oncology Group (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 fluorouracil (5-FU) or capecitabine * Will not undergo surgery for the study disease * Able to receive HDR brachytherapy
  • Absolute neutrophil count (ANC) >= 1.5 cells/mm^3
  • Platelets (PLT) >= 100,000/mm^3
  • Creatinine < 1.5 x the upper limit of normal (ULN) or calculated creatinine clearance >= 50 cc/min
  • 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)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x ULN or < 5 x 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

Locations & Contacts

New Jersey

Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Abraham Jing-Ching Wu
Phone: 212-639-5257
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Abraham Jing-Ching Wu
Phone: 212-639-5257

New York

Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Abraham Jing-Ching Wu
Phone: 212-639-5257
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Abraham Jing-Ching Wu
Phone: 212-639-5257
Rockville Centre
Memorial Sloan Kettering Rockville Centre
Status: Active
Contact: Abraham Jing-Ching Wu
Phone: 212-639-5257
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Abraham Jing-Ching Wu
Phone: 212-639-5257

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose and to assess rates of acute and late toxicity after endorectal brachytherapy with concurrent capecitabine or 5-fluorouracil (fluorouracil).

SECONDARY OBJECTIVES:

I. To determine rates of local failure-free, distant metastasis-free, progression-free, and overall survival after completion of endorectal brachytherapy with concurrent chemotherapy.

II. To correlate changes in magnetic resonance imaging (MRI) with dynamic contrast-enhanced (DCE) and diffusion weighted imaging (DWI) series at 3, 6, and 12 months after the completion of endorectal brachytherapy with concurrent chemotherapy and clinical complete response assessed by proctoscopy at each of these time points.

III. To assess bowel function using the Memorial Sloan-Kettering Cancer Center (MSKCC) Bowel Function Instrument (BFI) following endorectal brachytherapy with concurrent chemotherapy.

IV. To assess quality of life using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Cancer (QLQ)-C30 and the European Quality of life (EuroQol) 5D-5L questionnaires following endorectal brachytherapy with concurrent chemotherapy.

OUTLINE: This is a dose-escalation study of high-dose-rate brachytherapy.

Patients undergo high-dose-rate endorectal brachytherapy once weekly for 3 weeks. Patients also receive concurrent capecitabine orally (PO) twice daily (BID) 5 days a week or fluorouracil intravenously (IV) continuously during the 3 weeks of brachytherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days and at 3, 6, 12, 18, and 24 months.

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Memorial Sloan Kettering Cancer Center

Principal Investigator
Abraham Jing-Ching Wu

Trial IDs

Primary ID 14-104
Secondary IDs NCI-2014-01649
Clinicaltrials.gov ID NCT02199236