Combination Chemotherapy and Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00613080
First received: February 9, 2008
Last updated: June 11, 2013
Last verified: June 2013
Results First Received: April 12, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Colorectal Cancer
Interventions: Drug: capecitabine
Drug: oxaliplatin
Procedure: resection
Radiation: radiation therapy
Drug: FOLFOX

  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
No text entered.

Reporting Groups
  Description
IMRT + Chemotherapy , Resection, Postoperative Chemotherapy Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)

Participant Flow:   Overall Study
    IMRT + Chemotherapy , Resection, Postoperative Chemotherapy  
STARTED     79  
COMPLETED     68 [1]
NOT COMPLETED     11  
Ineligible / no protocol treatment                 11  
[1] Subjects contributing data to the primary analysis are considered to have completed the study.



  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.
All eligible patients.

Reporting Groups
  Description
IMRT + Chemotherapy , Resection, Postoperative Chemotherapy Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)

Baseline Measures
    IMRT + Chemotherapy , Resection, Postoperative Chemotherapy  
Number of Participants  
[units: participants]
  68  
Age  
[units: years]
Median ( Full Range )
  51  
  ( 29 to 77 )  
Gender  
[units: participants]
 
Female     30  
Male     38  



  Outcome Measures

1.  Primary:   The Percentage of Patients Experiencing Treatment-related Gastrointestinal Adverse Events ≥ Grade 2 Per National Cancer Institute (NCI) Common Terminology Critereia for Adverse Events (CTCAE) v. 3.0, Occurring Preoperatively   [ Time Frame: From start of treatment to surgery or ≤ 90 days from the Start of Concurrent Treatment (for patients not undergoing surgery) ]
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Measure Type Primary
Measure Title The Percentage of Patients Experiencing Treatment-related Gastrointestinal Adverse Events ≥ Grade 2 Per National Cancer Institute (NCI) Common Terminology Critereia for Adverse Events (CTCAE) v. 3.0, Occurring Preoperatively
Measure Description The percentage of patients experiencing preoperative treatment-related gastrointestinal adverse events ≥ grade 2. If patient did not receive surgery, then such adverse events <= 90 days from the start of concurrent treatment are included.
Time Frame From start of treatment to surgery or ≤ 90 days from the Start of Concurrent Treatment (for patients not undergoing surgery)  
Safety Issue Yes  

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 subjects who started study treatment.

Reporting Groups
  Description
IMRT + Chemotherapy , Resection, Postoperative Chemotherapy Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)

Measured Values
    IMRT + Chemotherapy , Resection, Postoperative Chemotherapy  
Number of Participants Analyzed  
[units: participants]
  68  
The Percentage of Patients Experiencing Treatment-related Gastrointestinal Adverse Events ≥ Grade 2 Per National Cancer Institute (NCI) Common Terminology Critereia for Adverse Events (CTCAE) v. 3.0, Occurring Preoperatively  
[units: percentage¬†of¬†patients]
Number ( 90% Confidence Interval )
  51  
  ( NA to 59 ) [1]
[1] This is a one-sided confidence interval.


Statistical Analysis 1 for The Percentage of Patients Experiencing Treatment-related Gastrointestinal Adverse Events ≥ Grade 2 Per National Cancer Institute (NCI) Common Terminology Critereia for Adverse Events (CTCAE) v. 3.0, Occurring Preoperatively
Groups [1] IMRT + Chemotherapy , Resection, Postoperative Chemotherapy
Method [2] Chi-squared
P Value [3] 0.93
Proportion (reported as percentage) [4] 51
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This study was designed for a one-sided chi-square test to detect at least 12% reduction in the 40% rate of ≥ grade 2 treatment-related preoperative GI AEs from the conventional radiotherapy / capecitabine /oxaliplatin arm of study RTOG 0247 with 80% power and a one-sided type I error rate of 0.10.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



2.  Secondary:   Intensity-modulated Radiotherapy (IMRT) Feasibility   [ Time Frame: IMRT planning and dosing data is centrally reviewed for quality assurance ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Pathologic Complete Response Rate   [ Time Frame: After protocol surgery ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   All Treatment-related Adverse Events Per NCI CTCAE v3.0 Preoperative, Postoperative, and Overall   [ Time Frame: Three timeframes: Start of treatment to surgery, Surgery to 3 months after the completion of postoperative chemotherapy and Combined ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Patterns of Failure (i.e., Local, Regional, and Distant), Including Overall Survival (Death Due to Any Cause)   [ Time Frame: From registration to date of local failure, regional failure, distant failure, death or last follow-up ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Rate of Anterior Posterior Resections   [ Time Frame: From registration to end of follow-up ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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.  


Results Point of Contact:  
Name/Title: Wendy Seiferheld
Organization: Radiation Therapy Oncology Group (RTOG)
e-mail: wseiferheld@acr.com


No publications provided


Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00613080     History of Changes
Other Study ID Numbers: RTOG-0822, CDR0000586277
Study First Received: February 9, 2008
Results First Received: April 12, 2013
Last Updated: June 11, 2013
Health Authority: United States: Federal Government