Complete Neoadjuvant Treatment for REctal Cancer (CONTRE)

This study has been completed.
Sponsor:
Collaborators:
Memorial Hospital of Rhode Island
Rhode Island Hospital
The Miriam Hospital
Information provided by (Responsible Party):
William Sikov, Brown University
ClinicalTrials.gov Identifier:
NCT01363843
First received: May 26, 2011
Last updated: July 25, 2014
Last verified: July 2014
Results First Received: June 17, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Colon Cancer
Rectal Cancer
Interventions: Drug: FOLFOX6
Radiation: RT with concurrent chemotherapy
Procedure: Surgery

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
39 patients we enrolled, 36 completed all 8 cycles of induction modified FOLFOX6, 35 patients completed chemo-radiation, 38 patients underwent surgery.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Study Arm Only

Induction therapy - Modified FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV, followed by 5-FU 400 mg/m2 IV, followed 5-FU 2400 mg/m2 IV by continuous infusion over 46 hours - Repeat q14 days x 8 cycles

Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)

  1. 5-FU 225 mg/m2 by continuous infusion starting the morning of the first dose of radiation and ending the morning after the last dose of radiation
  2. Capecitabine 825 mg/m2 PO BID

50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)

Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)

  1. 5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)
  2. Capecitabine

Participant Flow:   Overall Study
    Study Arm Only  
STARTED     39  
COMPLETED     38 [1]
NOT COMPLETED     1  
[1] 39 enrolled, 36 completed 8 cycles of mFOLFOX6, 35 completed chemo-radiation, 38 underwent surgery.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Study Arm

Induction therapy - Modified FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV, followed by 5-FU 400 mg/m2 IV, followed 5-FU 2400 mg/m2 IV by continuous infusion over 46 hours - Repeat q14 days x 8 cycles

Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)

  1. 5-FU 225 mg/m2 by continuous infusion starting the morning of the first dose of radiation and ending the morning after the last dose of radiation
  2. Capecitabine 825 mg/m2 PO BID

50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)

Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)

  1. 5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)
  2. Capecitabine

Baseline Measures
    Study Arm  
Number of Participants  
[units: participants]
  39  
Age  
[units: years]
Median ( Full Range )
  61  
  ( 30 to 79 )  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     26  
>=65 years     13  
Gender  
[units: participants]
 
Female     13  
Male     26  
Region of Enrollment  
[units: participants]
 
United States     39  



  Outcome Measures

1.  Primary:   Incidence of Complete Resection   [ Time Frame: approx 6 months ]

2.  Secondary:   Evaluate the Toxicity of Study Therapy   [ Time Frame: approx 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: William Sikov, MD and Kimberly Perez, MD
Organization: BrUOG
phone: 4018633000
e-mail: kayla_rosati@brown.edu


No publications provided


Responsible Party: William Sikov, Brown University
ClinicalTrials.gov Identifier: NCT01363843     History of Changes
Other Study ID Numbers: BrUOG 224
Study First Received: May 26, 2011
Results First Received: June 17, 2014
Last Updated: July 25, 2014
Health Authority: United States: Institutional Review Board