S0713: Oxaliplatin, Capecitabine, Cetuximab, and RT Followed By Surgery in Pts W/Stage II or III Rectal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00686166
First received: May 28, 2008
Last updated: January 26, 2016
Last verified: January 2016
Results First Received: January 26, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Colorectal Cancer
Interventions: Biological: cetuximab
Drug: capecitabine
Drug: oxaliplatin
Procedure: therapeutic surgical procedure
Radiation: radiation therapy

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Chemo + Chemo and Radiation + Surgery

Chemotherapy Cycle 1 (1 cycle is 35 days):

  • Oxaliplatin, 50 mg/m^2, IV, Days 1,8,15,22,29
  • Cetuximab, 400 mg/m^2, IV, Day 1
  • Cetuximab, 250 mg/m^2, IV, Days 8,15,22,29
  • Capecitabine, 1650 mg/m^2/day, PO, Monday-Friday (Day 1-35)

Chemotherapy+ Radiation Cycle 2:

  • Oxaliplatin, 50 mg/m^2, IV, Days 50,57,71,78
  • Cetuximab, 250 mg/m^2, IV, Days 50,57,64,71,78
  • Capecitabine, 1650 mg/m^1, PO, Monday-Friday (Day 50-84)
  • Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.

Therapeutic Surgical procedure: Resection


Participant Flow:   Overall Study
    Chemo + Chemo and Radiation + Surgery  
STARTED     83  
Eligible     78  
Eligible and Began Protocol Therapy     74  
COMPLETED     63  
NOT COMPLETED     20  
Adverse Event                 7  
Withdrawal by Subject                 1  
Progression/Relapse                 1  
Death                 1  
Not Protocol Specified                 1  
Ineligible                 5  
Did not begin protocol therapy                 4  



  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.
Eligible patients who began protocol therapy.

Reporting Groups
  Description
Chemo + Chemo and Radiation + Surgery

Chemotherapy Cycle 1 (1 cycle is 35 days):

  • Oxaliplatin, 50 mg/m^2, IV, Days 1,8,15,22,29
  • Cetuximab, 400 mg/m^2, IV, Day 1
  • Cetuximab, 250 mg/m^2, IV, Days 8,15,22,29
  • Capecitabine, 1650 mg/m^2/day, PO, Monday-Friday (Day 1-35)

Chemotherapy+ Radiation Cycle 2:

  • Oxaliplatin, 50 mg/m^2, IV, Days 50,57,71,78
  • Cetuximab, 250 mg/m^2, IV, Days 50,57,64,71,78
  • Capecitabine, 1650 mg/m^1, PO, Monday-Friday (Day 50-84)
  • Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions.

Therapeutic Surgical procedure: Resection


Baseline Measures
    Chemo + Chemo and Radiation + Surgery  
Number of Participants  
[units: participants]
  74  
Age  
[units: years]
Median (Full Range)
  56.4  
  (25.5 to 77.6)  
Gender  
[units: participants]
 
Female     22  
Male     52  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     6  
Not Hispanic or Latino     67  
Unknown or Not Reported     1  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     1  
Asian     6  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     3  
White     63  
More than one race     0  
Unknown or Not Reported     1  



  Outcome Measures
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1.  Primary:   Pathologic Complete Response Rate   [ Time Frame: 15-20 weeks from registration ]

2.  Secondary:   3-year Disease-free Survival   [ Time Frame: 3 years ]

3.  Secondary:   Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to This Regimen.   [ Time Frame: Up to 4 years ]


  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
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  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: SWOG Statistician
Organization: SWOG Statistical Center
phone: 206-667-4408



Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00686166     History of Changes
Other Study ID Numbers: S0713
S0713 ( Other Identifier: SWOG )
U10CA032102 ( US NIH Grant/Contract Award Number )
Study First Received: May 28, 2008
Results First Received: January 26, 2016
Last Updated: January 26, 2016
Health Authority: United States: Federal Government