At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 9 enrolled

Drug / intervention

capecitabine and IMRT (if randomized to this arm) +4 moredrug

Likely dose

capecitabine and IMRT (if randomized to this arm) 825mg/m2from record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02017704

NCT02017704Phase 2Completed

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Chemoradiation OR Brachytherapy for RECTal Cancer

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Dec 23, 2013·Updated Oct 17, 2023

In Brief

A Phase 2 clinical trial evaluating Endo-HDR (if randomized to this arm), capecitabine and IMRT (if randomized to this arm), and 3 other interventions for Rectal Cancer. Completed, enrolled 9 participants across 4 sites.

Detailed 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).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsRectal Cancer

CountriesUnited States

CollaboratorsElekta Limited

Timeline

Phase 2CompletedFinished

2014201520162017201820192020202120222023202420252026

First PostedDec 2013

Enrollment StartJun 2014

Primary CompletionSep 2021

Study CompletionJan 2023

TodayJul 2026

First PostedDec 23, 2013

Enrollment StartJun 12, 2014

Primary CompletionSep 30, 2021

Study CompletionJan 31, 2023

TodayJul 2, 2026

Enrollment to primary: 7.3 yearsPosted 12.5 years ago

Interventions

Endo-HDR (if randomized to this arm)radiation

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

capecitabine and IMRT (if randomized to this arm)drug

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

IMRT (intensity modulated radiation therapy)radiation

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

FOLFOX6drug

* 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.

Surgeryprocedure

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.