Chemoradiation or Brachytherapy for Rectal Cancer (CORRECT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Collaborator:
Nucletron
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT02017704
First received: December 5, 2013
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

This research is being done to compare the effectiveness of high dose endorectal brachytherapy (END-HDR) and the standard treatment option of chemoradiation with Capecitabine in the treatment of cancer of the lowest part of the bowel (rectum).


Condition Intervention Phase
Rectal Cancer
Radiation: Endo-HDR (if randomized to this arm)
Drug: capecitabine and IMRT (if randomized to this arm)
Radiation: IMRT (intensity modulated radiation therapy)
Drug: FOLFOX6
Procedure: Surgery
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Chemoradiation OR Brachytherapy for RECTal Cancer

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Pathologic complete response rate [ Time Frame: Baseline up to 60 months ] [ Designated as safety issue: No ]
    The primary endpoint is pathologic complete response rate, which will be estimated for both arms as the proportion of patients who achieve pathologic complete response after the treatment.


Secondary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: Baseline up to 60 months ] [ Designated as safety issue: Yes ]
    The acute and chronic toxicity and adverse events will be summarized in frequency tables by type and grade for each arm and will be compared between arms using Fisher's exact tests.

  • Quality of Life Comparison [ Time Frame: Baseline up to 60 months ] [ Designated as safety issue: No ]
    Qualify of life will be assessed via several questionnaires.. These questionnaires will look at urinary/bowel toxicity, sphincter function, and sexual dysfunction.

  • Time to death [ Time Frame: Baseline up to 60 months ] [ Designated as safety issue: No ]
    Assessing the difference time to death rates among study participants.

  • Time to distant metastases free surivial [ Time Frame: Baseline up to 60 months ] [ Designated as safety issue: No ]
    Compare distant metastasis for both Endo-HDR and CRT.

  • Time to progression free survival [ Time Frame: Baseline up to 60 months ] [ Designated as safety issue: No ]
    Compare progression free survival for both Endo-HDR and CRT.

  • Time to local disease recurrence [ Time Frame: Baseline up to 60 months ] [ Designated as safety issue: No ]
    Compare locoregional control for both Endo-HDR and CRT.


Estimated Enrollment: 138
Study Start Date: October 2013
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IMRT and Capecitabine (potentially randomized to this arm)
Patients will receive IMRT along with capecitabine. External radiotherapy will be based on contouring guidelines from the RTOG atlas and Radiation Therapy Oncology Group (RTOG 0822) with some modifications
Drug: capecitabine and IMRT (if randomized to this arm)
Capecitabine shall be delivered at 825mg/m2 BID during IMRT radiotherapy
Other Name: Xeloda
Radiation: IMRT (intensity modulated radiation therapy)
Patients will receive IMRT along with capecitabine. External radiotherapy will be based on contouring guidelines from the RTOG atlas and Radiation Therapy Oncology Group (RTOG 0822) with some modifications
Experimental: Endo-HDR (potentially randomized to this arm)
Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy
Radiation: Endo-HDR (if randomized to this arm)
Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy
FOLFOX6 (either arm receives this)
  • Oxaliplatin: 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
  • 5-Fluorouracil (5-FU) bolus 400mg/m² following the oxaliplatin/FA infusions
  • 5-FU continuous infusion 2400 mg/m², 46-h infusion following the 5-FU bolus

Cycle length: 14 days (2 weeks)

Duration of treatment: 12 cycles

Drug: FOLFOX6
  • Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
  • Leucovorin - bolus 400mg/m² following the oxaliplatin/FA infusions
  • 5 Fluorouracil (5FU) - 2400 mg/m², 46-h infusion following the 5-FU bolus An outpatient, 46 hour continuous IV infusion provided by a home IV infusion company. The 5FU is delivered by a small pump worn in a fanny pack around the waist. The home IV infusion company will arrange your disconnect at the end of the infusion.
Other Name: Oxaliplatin, Leucovorin, 5 Flourouracil
Surgery (either arm receives this)

After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine:

  1. Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam.
  2. Mobility of tumor as assessed if possible by rectal exam
  3. Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis.
Procedure: Surgery

After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine:

Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam.

Mobility of tumor as assessed if possible by rectal exam Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed adenocarcinoma of the rectum
  • Appropriate tumor staging and location
  • Patients should be suitable candidates for surgery and chemotherapy
  • ECOG/WHO performance status 0-1
  • Patients must be 18 years or older
  • No previous history of pelvic radiation
  • Patients must have acceptable organ and marrow function
  • Non pregnant, non-breast feeding females under active contraception
  • Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

  • Evidence of distant metastatic disease
  • Evidence of sphincter invasion on MRI
  • Prior history of radiation to the pelvis
  • Prior malignancy except for adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ, DCIS, or other cancer from which the patient has been disease free for at least 3 years
  • Presence of multiple small bowel loops trapped within the immediate tumor bed (post hysterectomy or prostatectomy).
  • Use of any investigational agent within the 4 weeks preceding enrollment
  • Previous exposure to chemotherapy for rectal cancer
  • Uncontrolled intercurrent illness including but not limited to, ongoing or active infections (or infections requiring systemic treatment), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant and breastfeeding women are excluded, as well as women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control (hormonal or barrier method of birth control; abstinence) to avoid pregnancy for the duration of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study she should inform her treating physician immediately.
  • Women who are not post-menopausal and have a positive urine or serum pregnancy test or refuse to take a pregnancy test.
  • Contraindication for safe MRI, implants, or other conditions that interfere with imaging required for the study (e.g., pacemaker or non-MRI compatible hip prostheses). Note: Subjects with bilateral hip implants are not eligible for the study. Subjects with a unilateral hip implant may be eligible assuming the implant is MRI compatible and does not present artifact on MRI in the areas of interest.
  • Subject is pacemaker dependent.
  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: NCT02017704

Contacts
Contact: Joseph Herman, M.D. 443-502-3823 jherma15@jhmi.edu
Contact: Katharine Oteiza, M.S. 410-614-3158 koteiza1@jhmi.edu

Locations
United States, Florida
Moffitt Cancer Center Not yet recruiting
Tampa`, Florida, United States, 33607
Contact: Matthew Biagioli., M.D.         
United States, Georgia
Winship Cancer Institute, Emory University Not yet recruiting
Atlanta, Georgia, United States
United States, Maryland
The SKCCC at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Joseph Herman, M.D.    443-502-3823    jherma15@jhmi.edu   
Contact: Katharine Oteiza, M.S.    410-614-3158    koteiza1@jhmi.edu   
Sub-Investigator: Susan Gearhart, M.D.         
Sub-Investigator: Laura Wood, M.D., Ph.D.         
Sub-Investigator: Nilofer` Azad, M.D.         
Sub-Investigator: Luis Diaz, M.D.         
Sub-Investigator: Elizabeth Wick, M.D.         
Sub-Investigator: Sandy Fang, M.D.         
Sub-Investigator: Susannah Ellsworth, M.D.         
Sub-Investigator: Jonathan Efron, M.D.         
Sub-Investigator: Jennifer Barsky-Reese, Ph.D.         
United States, New York
Beth Israel Hospital Not yet recruiting
New York, New York, United States, 10003
Contact: Kenneth Hu, M.D.    212-844-8087    khu@chpnet.org   
United States, North Carolina
Wake Forest Cancer Center Not yet recruiting
Winston Salem, North Carolina, United States
Contact: William Blackstock, M.D.         
United States, Utah
Gamma West Cancer Services Not yet recruiting
Salt Lake City, Utah, United States
Canada, Quebec
Segal Cancer Centre Not yet recruiting
Montreal, Quebec, Canada
Contact: Chantel Cadieux, Ph.D.    1-514-340-8222      
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Nucletron
Investigators
Principal Investigator: Joseph Herman, M.D. The SKCCC at Johns Hopkins
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02017704     History of Changes
Other Study ID Numbers: J1360, NA_00082167
Study First Received: December 5, 2013
Last Updated: June 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Endorectal Brachytherapy Radiation Therapy
Intensity Modulated Radiation Therapy and Capecitabine

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
Leucovorin
Oxaliplatin
Capecitabine
Fluorouracil
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 20, 2014