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

NCT ID: NCT01226979

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-26
• Study Completion Date: 2018-07-31

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.

Detailed Description

This study is a pilot study open to patients with clinical stage T2N1 or T3N0-1 resectable rectal cancer. 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. This study assumes that the rate of pathological response to HDRBT will be similar to historical controls (conventional neoadjuvant chemoradiation). All patients will receive postoperative standard 5-fluorouracil (FU) based chemotherapy (at the discretion of the medical oncologist). The clinical response will be assessed with endoscopic/ultrasound, pelvic MRI and fluorodeoxyglucose (FDG)-positron emission tomography (PET)/CT. In addition, tissue and serum will be collected to evaluate for biological predictors of response to therapy. The endpoints of this study include adverse events (gastrointestinal toxicity), quality of life as measured by the quality of life questionnaire (QLQ)-C30, and tumor regression/response.

Conditions

Rectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HDRBT (High Dose Rectal Brachytherapy)

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

Group Type: EXPERIMENTAL

High-dose endorectal brachytherapy (HDRBT)

Intervention Type: 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.

Interventions

High-dose endorectal brachytherapy (HDRBT)

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.

Intervention Type: RADIATION

Other Intervention Names

HDRBT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amol K Narang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Department of Radiation Oncology

Locations

Johns Hopkins Medical Institutions

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00029263

Identifier Type: OTHER

Identifier Source: secondary_id

J0977

Identifier Type: -

Identifier Source: org_study_id