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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) ]

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

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


  Serious Adverse Events
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Time Frame No text entered.
Additional Description Per the protocol, toxicity data was collected via CTCAE (Common Terminology Criteria for Adverse Events) 3.0 then mapped to CTCAE 4.0 to report on this website. Subjects experiencing more than one of a given SAE (serious adverse event) are counted only once for that SAE. The same methodology was applied for non-SAE adverse events (AE).

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)

Serious Adverse Events
    IMRT + Chemotherapy , Resection, Postoperative Chemotherapy  
Total, serious adverse events    
# participants affected / at risk     21/68 (30.88%)  
Blood and lymphatic system disorders    
Anemia * 1  
# participants affected / at risk     4/68 (5.88%)  
Cardiac disorders    
Atrial fibrillation * 1  
# participants affected / at risk     1/68 (1.47%)  
Myocardial infarction * 1  
# participants affected / at risk     1/68 (1.47%)  
Paroxysmal atrial tachycardia * 1  
# participants affected / at risk     1/68 (1.47%)  
Sinus tachycardia * 1  
# participants affected / at risk     1/68 (1.47%)  
Gastrointestinal disorders    
Abdominal pain * 1  
# participants affected / at risk     1/68 (1.47%)  
Diarrhea * 1  
# participants affected / at risk     8/68 (11.76%)  
Dyspepsia * 1  
# participants affected / at risk     1/68 (1.47%)  
Dysphagia * 1  
# participants affected / at risk     1/68 (1.47%)  
Enterocolitis * 1  
# participants affected / at risk     1/68 (1.47%)  
Esophageal hemorrhage * 1  
# participants affected / at risk     1/68 (1.47%)  
Esophagitis * 1  
# participants affected / at risk     1/68 (1.47%)  
Gastrointestinal disorders - Other * 1  
# participants affected / at risk     2/68 (2.94%)  
Mucositis oral * 1  
# participants affected / at risk     1/68 (1.47%)  
Nausea * 1  
# participants affected / at risk     3/68 (4.41%)  
Small intestinal obstruction * 1  
# participants affected / at risk     1/68 (1.47%)  
Vomiting * 1  
# participants affected / at risk     3/68 (4.41%)  
General disorders    
Fatigue * 1  
# participants affected / at risk     2/68 (2.94%)  
Fever * 1  
# participants affected / at risk     2/68 (2.94%)  
Infections and infestations    
Infections and infestations - Other * 1  
# participants affected / at risk     3/68 (4.41%)  
Lung infection * 1  
# participants affected / at risk     1/68 (1.47%)  
Injury, poisoning and procedural complications    
Rectal anastomotic leak * 1  
# participants affected / at risk     1/68 (1.47%)  
Wound dehiscence * 1  
# participants affected / at risk     1/68 (1.47%)  
Investigations    
Alkaline phosphatase increased * 1  
# participants affected / at risk     1/68 (1.47%)  
Aspartate aminotransferase increased * 1  
# participants affected / at risk     1/68 (1.47%)  
Creatinine increased * 1  
# participants affected / at risk     1/68 (1.47%)  
Lymphocyte count decreased * 1  
# participants affected / at risk     1/68 (1.47%)  
Neutrophil count decreased * 1  
# participants affected / at risk     2/68 (2.94%)  
Platelet count decreased * 1  
# participants affected / at risk     1/68 (1.47%)  
White blood cell decreased * 1  
# participants affected / at risk     3/68 (4.41%)  
Metabolism and nutrition disorders    
Anorexia * 1  
# participants affected / at risk     1/68 (1.47%)  
Dehydration * 1  
# participants affected / at risk     5/68 (7.35%)  
Hyperglycemia * 1  
# participants affected / at risk     2/68 (2.94%)  
Hypoalbuminemia * 1  
# participants affected / at risk     2/68 (2.94%)  
Hypocalcemia * 1  
# participants affected / at risk     1/68 (1.47%)  
Hypokalemia * 1  
# participants affected / at risk     4/68 (5.88%)  
Hyponatremia * 1  
# participants affected / at risk     4/68 (5.88%)  
Nervous system disorders    
Dizziness * 1  
# participants affected / at risk     1/68 (1.47%)  
Ischemia cerebrovascular * 1  
# participants affected / at risk     1/68 (1.47%)  
Peripheral sensory neuropathy * 1  
# participants affected / at risk     1/68 (1.47%)  
Psychiatric disorders    
Insomnia * 1  
# participants affected / at risk     1/68 (1.47%)  
Renal and urinary disorders    
Acute kidney injury * 1  
# participants affected / at risk     1/68 (1.47%)  
Urinary incontinence * 1  
# participants affected / at risk     1/68 (1.47%)  
Urinary tract obstruction * 1  
# participants affected / at risk     1/68 (1.47%)  
Respiratory, thoracic and mediastinal disorders    
Dyspnea * 1  
# participants affected / at risk     1/68 (1.47%)  
Hypoxia * 1  
# participants affected / at risk     1/68 (1.47%)  
Pneumonitis * 1  
# participants affected / at risk     1/68 (1.47%)  
Skin and subcutaneous tissue disorders    
Hyperhidrosis * 1  
# participants affected / at risk     1/68 (1.47%)  
Pruritus * 1  
# participants affected / at risk     1/68 (1.47%)  
Rash maculo-papular * 1  
# participants affected / at risk     1/68 (1.47%)  
Urticaria * 1  
# participants affected / at risk     1/68 (1.47%)  
Vascular disorders    
Hypertension * 1  
# participants affected / at risk     1/68 (1.47%)  
Thromboembolic event * 1  
# participants affected / at risk     4/68 (5.88%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, CTCAE (4.0)




  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