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

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

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.

Study Overview

• Status: Completed
• Conditions: Rectal Cancer
• Intervention / Treatment: Radiation: High-dose endorectal brachytherapy (HDRBT)

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Johns Hopkins Medical Institutions

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Radiation: 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.; Other Names: HDRBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores	The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 form is a self-assessment completed by patients which examines current symptoms and functionality. Total score ranges from 0 to 100, a higher score represents a higher ("better") quality of life.	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	The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-CR38 form is a self-assessment completed by patients and examine current symptoms and functionality. Each item is scored from 1 to 4. Total score range is from 38-152. A higher score represents better quality of life.	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	The European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) form is a self-assessment completed by patients and examine current symptoms and functionality. Each item is scored from 1 to 4. Total score ranges from 29 - 116. A higher score represents better quality of life.	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	Acute gastrointestinal toxicity will be assessed using the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0). CTCAE v4.0 ratings of 3 or 4 (seriousness of 17%) adverse events will be assessed and reported.	3-6 weeks
Number of Participants With Clinical Response of High-Dose-Rate Endorectal Brachytherapy (HDRBT) Brachytherapy	Radiographic measurements of pelvic MRI and fluorodeoxyglucose (FDG) positron emission tomography (PET)/CT imaging will be used to classify patients as responders or non-responders to HDRBT using standard RECIST criteria. Response Evaluation Criteria In Solid Tumors (RECISTv1.0) is defined as follows: 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.	3 to 6 weeks post-treatment

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Investigators: Principal Investigator: Amol K Narang, M.D., Johns Hopkins Department of Radiation Oncology

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2010
• Primary Completion (Actual): September 23, 2016
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: September 21, 2010
• First Submitted That Met QC Criteria: October 20, 2010
• First Posted (Estimated): October 22, 2010

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: rectal cancer; high dose endorectal brachytherapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Rectal Neoplasms
• Other Study ID Numbers: J0977; NA_00029263 (Other Identifier: JHMIRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No