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Phase II Trial of Preoperative High-dose-rate Endorectal Brachytherapy and FOLFOX Chemotherapy for Rectal Cancer (HDRBT)

This study has been withdrawn prior to enrollment.
(No participants were enrolled)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01659424
First Posted: August 7, 2012
Last Update Posted: December 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
St. Luke's-Roosevelt Hospital Center
Information provided by (Responsible Party):
Beth Israel Medical Center
  Purpose

Standard treatment for rectum cancer is a pre-surgery course of external beam radiotherapy given with chemotherapy at the same time. External beam radiation can increase side effects both short and long-term by exposing normal tissue nearby the tumor such as the bladder, bowel and sexual organs. Instead, this study will use a different way of delivering radiation called brachytherapy to decrease normal tissue radiation exposure. Patient will be given three chemotherapy medications both before and after surgery: oxaliplatin (also called EloxatinTM) in combination with 5-fluorouracil (5-FU) and leucovorin (also called Folinic Acid).

The purpose of this study is to find out whether giving chemotherapy and brachytherapy before surgery can: 1) enable patient's surgeon to successfully remove tumor 2) lower the risk of tumor recurrence 3) avoid patient having the side effects related to chemotherapy and external beam radiation therapy and 4) improve patient's ability to complete chemotherapy.


Condition Intervention Phase
Rectal Cancer Radiation: High Dose Rate Endorectal Brachytherapy (HDR-ERBT) Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Preoperative High-dose-rate Endorectal Brachytherapy (BT) FOLFOX Chemotherapy for Stage II/III Rectal Cancer

Further study details as provided by Beth Israel Medical Center:

Primary Outcome Measures:
  • Phase II Trial of Preoperative High-dose-rate Endorectal Brachytherapy (BT) Improve Compliance [ Time Frame: five years ]
    Investigator propose combining pre-operative FOLFOX chemotherapy with high dose rate endorectal brachytherapy followed by surgery and then additional FOLFOX chemotherapy to further improve compliance.


Secondary Outcome Measures:
  • Locoregional failure [ Time Frame: 5 years ]
  • Distant Metastasis [ Time Frame: 5 years ]
  • Toxicity [ Time Frame: 1 year ]
    Number of participant with Bladder, Bowel, Sexual function and Bone Marrow Toxicity.

  • 4) Quality of Life [ Time Frame: 5 year ]

Enrollment: 0
Study Start Date: June 2011
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single Arm
This is a single arm study.
Radiation: High Dose Rate Endorectal Brachytherapy (HDR-ERBT)
Combining pre-operative FOLFOX chemotherapy with HDR-ERBT (Radiation therapy) followed by surgery then additional FOLFOX chemotherapy to decrease the risk of distant metastasis and to maintain excellent locoregional control with decreased morbidity.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adenocarcinoma of the rectum
  • T2/3 tumors at ≤ 12cm from the A-V margin (below the peritoneal reflection)
  • Tumors with a lumen to allow the positioning of the rectal applicator.
  • Tumor of less than 3.5cm thickness documented at the CT Simulator
  • Patient should be a suitable candidate for surgery and chemotherapy
  • ECOG/WHO performance status 0-1
  • Age 18 or older
  • No previous history of pelvic radiation or chemotherapy
  • Adequate marrow reserve, with absolute neutrophil count greater than or equal to 1.5 x 109/L and platelets greater than or equal to 100 x 109/L.
  • Serum creatinine <= 1.5 x ULN; bilirubin <= 1.5 x ULN; ALT<= 2.5 x ULN
  • Non pregnant, non-lactating females under active contraception
  • No peripheral neuropathy > grade 2

Exclusion Criteria:

  • Evidence of necrotic pelvic nodes or ≥ 1 cm
  • Evidence of distant metastasis
  • Previous pelvic radiation
  • Other cancer except for non-melanomatous carcinoma of the skin or CIS of the cervix.
  • Presence of multiples small bowel loops trapped within the immediate tumor bed (post hysterectomy or prostatectomy).
  • Use of any investigational agent within the 4 weeks preceding enrolment
  • Exposure to chemotherapy during the neoadjuvant phase
  • Documented distant metastases
  • Significant neuropathy
  • History of allergic reactions to platin compounds or 5-FU or leucovorin
  • Uncontrolled intercurrent illness such as active infection, congestive heart failure or coronary artery disease.
  • Psychiatric illness that would limit compliance with study requirements
  • Pregnancy or lactation
  • HIV infection
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01659424


Locations
United States, New York
Beth Isael Medical Center
New York, New York, United States, 10003
St-Lukes Roosevelt Hospital Medical Center
New York, New York, United States, 10018
Sponsors and Collaborators
Beth Israel Medical Center
St. Luke's-Roosevelt Hospital Center
Investigators
Principal Investigator: Kenneth Hu, MD Beth Israel Medical Center NY
  More Information

Additional Information:
Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT01659424     History of Changes
Other Study ID Numbers: HDRBT for Rectal cancer
First Submitted: April 24, 2012
First Posted: August 7, 2012
Last Update Posted: December 18, 2014
Last Verified: December 2014

Keywords provided by Beth Israel Medical Center:
Rectal cancer

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases