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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Beth Israel Medical Center
Sponsor:
Collaborator:
St. Luke's-Roosevelt Hospital Center
Information provided by (Responsible Party):
Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT01659424
First received: April 24, 2012
Last updated: June 6, 2014
Last verified: June 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • Distant Metastasis [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Number of participant with Bladder, Bowel, Sexual function and Bone Marrow Toxicity.

  • 4) Quality of Life [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: June 2011
Estimated Primary Completion Date: June 2016 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01659424

Contacts
Contact: Rotsen Rocha 212-844-8133 rrocha@chpnet.org

Locations
United States, New York
Beth Isael Medical Center Recruiting
New York, New York, United States, 10003
Contact: Rotsen Rocha    212-844-8133    rrocha@chpnet.org   
St-Lukes Roosevelt Hospital Medical Center Recruiting
New York, New York, United States, 10018
Contact: Takhir Mirzoyev, MD    212-523-7289      
Sub-Investigator: Paul Gliedman, MD         
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:
No publications provided

Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT01659424     History of Changes
Other Study ID Numbers: HDRBT for Rectal cancer
Study First Received: April 24, 2012
Last Updated: June 6, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 28, 2014