Chemoradiation or Brachytherapy for Rectal Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

June 12, 2014

Primary Completion Date

September 30, 2021

Study Completion Date

January 31, 2023

Conditions
Rectal Cancer
Interventions
RADIATION

Endo-HDR (if randomized to this arm)

Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy

DRUG

capecitabine and IMRT (if randomized to this arm)

Capecitabine shall be delivered at 825mg/m2 BID during IMRT radiotherapy

RADIATION

IMRT (intensity modulated radiation therapy)

Patients will receive IMRT along with capecitabine. External radiotherapy will be based on contouring guidelines from the RTOG atlas and Radiation Therapy Oncology Group (RTOG 0822) with some modifications

DRUG

FOLFOX6

"* Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion~* Leucovorin - bolus 400mg/m² following the oxaliplatin/FA infusions~* 5 Fluorouracil (5FU) - 2400 mg/m², 46-h infusion following the 5-FU bolus An outpatient, 46 hour continuous IV infusion provided by a home IV infusion company. The 5FU is delivered by a small pump worn in a fanny pack around the waist. The home IV infusion company will arrange your disconnect at the end of the infusion."

PROCEDURE

Surgery

"After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine:~Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam.~Mobility of tumor as assessed if possible by rectal exam Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis."

Trial Locations (4)

10003

Beth Israel Hospital, New York

21287

The SKCCC at Johns Hopkins, Baltimore

30322

Winship Cancer Institute, Emory University, Atlanta

33607

Moffitt Cancer Center, Tampa

All Listed Sponsors
collaborator

Elekta Limited

INDUSTRY

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

NCT02017704 - Chemoradiation or Brachytherapy for Rectal Cancer | Biotech Hunter | Biotech Hunter