Study of High-Dose-Rate Endorectal Brachytherapy (HDRBT) in the Treatment of Locally Advanced Low Rectal Cancer

NCT01226979 | Completed Results DMC

• 2 other identifiers: J0977NA_00029263
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This research is being done to see how effective high-dose rate endorectal brachytherapy (HDRBT) is in treating cancer of the lowest part of the bowel (rectum). In this study we want to try to decrease side effects and shorten the course of radiation treatment for patients with cancer of their rectum by using a high-dose rate endorectal brachytherapy (HDRBT). This is a different form of radiation than what is normally given (CRT). With HDRBT, the radiation is given through an applicator placed into the bowel next to the tumor. The radiation is directed at the tumor and a small area around it.

Conditions

Rectal Cancer

Keywords

rectal cancer; high dose endorectal brachytherapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Pathologic Complete Response

  Those participants whose surgical pathology indicated that they had a complete response measured by RECIST. Per Response Evaluation Criteria In Solid Tumors (RECISTv1.0). Complete response (CR) indicating no tumors, a partial (PR) response indicating at least a 30% decrease in tumor diameter (PR), progressive disease (PD) indicating 20% or greater increase in tumor diameter, and stable disease (SD) indicating that the tumor did not shrink significantly to be considered a partial response and did not grow significantly enough to be considered progressive disease.

  8 weeks

Secondary Outcomes (5)

• Number of Participants With Clinical Response of High-Dose-Rate Endorectal Brachytherapy (HDRBT) Brachytherapy

  3 to 6 weeks post-treatment

• Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores

  Pre-HDRBT, during HDRBT, post HDRBT week 1, week 2, weeks 3-6, 3-6 weeks post-op, every 4 months for 2 years and every 6 months for years 3 and 4

• Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores

  Pre-HDRBT, during HDRBT, post HDRBT week 1, week 2, weeks 3-6, 3-6 week post-op, every 4 months for 2 years and every 6 months for years 3 and 4

• Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores

  Pre-HDRBT, during HDRBT, post HDRBT week 1, week 2, weeks 3-6, 3-6 week post-op, every 4 months for 2 years and every 6 months for years 3 and 4

• Number of Participants With Acute Gastrointestinal Toxicity Associated With High-Dose-Rate Endorectal Brachytherapy (HDRBT) as Assessed by CTCAE v4.0

  3-6 weeks

Study Arms (1)

HDRBT (High Dose Rectal Brachytherapy)

EXPERIMENTAL

Radiation: High-dose endorectal brachytherapy The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer. A daily dose of 6.5 Gy over four consecutive days

Radiation: High-dose endorectal brachytherapy (HDRBT)

Interventions

High-dose endorectal brachytherapy (HDRBT) RADIATION

The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer.

Also known as: HDRBT

HDRBT (High Dose Rectal Brachytherapy)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically confirmed adenocarcinoma of the rectum
• Able to undergo local staging of the rectal tumor performed by MRI and/or endoscopic ultrasonography (EUS) demonstrating a T2N1 or T3N0-1 tumor
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Participants are willing to undergo initial therapy and if needed subsequent therapy prior to resection at Johns Hopkins Medical Institutions
• English as a primary language in order to complete the quality of life questionnaires

You may not qualify if:

• Patients with tumors \>12 cm from the anal verge.
• Near obstructing or bulky tumors which will not allow application of the endorectal probe
• Patients with distant metastatic disease
• Any pelvic lymph nodes outside of the mesorectum (iliac or inguinal)
• Prior history of radiation therapy to the pelvis
• Prior history of chemotherapy for rectal cancer
• Active connective tissue disease such as scleroderma or Crohn's disease

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Amol Narang, MD
• Organization: SKCCC at Johns Hopkinis

anarang2@jhmi.edu

(410) 955-7390

Study Officials

• Amol K Narang, M.D.

  Johns Hopkins Department of Radiation Oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: High-Dose-Rate Endorectal Brachytherapy (HDRBT)

Study Record Dates

• First Submitted: September 21, 2010
• First Posted: October 22, 2010
• Study Start: October 26, 2010
• Primary Completion: September 23, 2016
• Study Completion: July 31, 2018
• Last Updated: February 28, 2025
• Results First Posted: September 14, 2020

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)