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Chemoradiation or Brachytherapy for Rectal Cancer

NCT02017704 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-10-17

Study results available
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Summary

This research is being done to compare the effectiveness of high dose endorectal brachytherapy (END-HDR) and the standard treatment option of chemoradiation with Capecitabine in the treatment of cancer of the lowest part of the bowel (rectum).

Conditions

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.

Sponsors & Collaborators

  • Elekta Limited

    collaborator INDUSTRY

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Amol K Narang, M.D. · The SKCCC at Johns Hopkins

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-12
Primary Completion
2021-09-30
Completion
2023-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02017704 on ClinicalTrials.gov