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

Rectal Cancer Clinical Trial

— HDRBT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01226979
• Other study ID #: J0977
• Secondary ID: NA_00029263
• Status: Completed
• Phase: N/A
• Start date: October 26, 2010
• Est. completion date: July 31, 2018

Study information

• Verified date: August 2020
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 31, 2018
• Est. primary completion date: September 23, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins Medical Institutions	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Pathologic Complete Response	Those participants whose surgical pathology indicated that they had a complete response.	8 weeks
Secondary	Clinical Response of High-Dose-Rate Endorectal Brachytherapy (HDRBT)	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. Using RECIST, the types of response a patient can have are a complete response (CR), a partial response (PR), progressive disease (PD), and stable disease (SD).	3 to 6 weeks post-treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	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