High-Dose-Rate Brachytherapy and Chemotherapy in Treating Patients with Locally Recurrent or Residual Rectal or Anal Cancer Undergoing Non-operative Management
- 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
- 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
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).
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 Phase I
Trial Type Treatment
Memorial Sloan Kettering Cancer Center
Abraham Jing-Ching Wu
- Primary ID 14-104
- Secondary IDs NCI-2014-01649
- Clinicaltrials.gov ID NCT02199236