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Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage I Rectal Cancer

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ClinicalTrials.gov Identifier: NCT00114231
Recruitment Status : Completed
First Posted : June 14, 2005
Results First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Colorectal Cancer
Interventions: Drug: capecitabine
Drug: oxaliplatin
Procedure: neoadjuvant therapy
Radiation: radiation therapy

  Participant Flow

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
Original Dose Group External beam radiotherapy with megavoltage linear accelerators (≥ 6 MV) was delivered to a 3–4 field pelvis arrangement after CT-based simulation and computer-assisted treatment planning. Intensity-modulated radiotherapy was allowed. The original dose of radiotherapy was 1·8 Gy per day, 5 days a week for 5 weeks to a dose of 45 Gy to planning target volume 1, then a boost of 9 Gy to planning target volume 2 (defi ned as the gross tumour volume plus 2 cm) for a total dose of 54 Gy. This was accompanied by capecitabine (825 mg/m², twice daily, on days 1–14 and 22–35) and oxaliplatin (50 mg/m² on weeks 1, 2, 4, and 5). Surgery was done 4–8 weeks after completion of neoadjuvant chemoradiotherapy. Local excision was done using conventional transanal excision or transanal endoscopic microsurgery. Full-thickness excision of the tumour with a 1 cm surrounding margin of normal rectal wall was needed.
Revised Dose Group The radiotherapy was reduced to a total of 50·4 Gy by reducing the 9 Gy boost to 5·4 Gy, and capecitabine was reduced to 725 mg/m², twice daily, 5 days a week for 5 weeks. The dose of oxaliplatin was not changed. Surgery was done 4–8 weeks after completion of neoadjuvant chemoradiotherapy. Local excision was done using conventional transanal excision or transanal endoscopic microsurgery. Full-thickness excision of the tumour with a 1 cm surrounding margin of normal rectal wall was needed.

Participant Flow:   Overall Study
    Original Dose Group   Revised Dose Group
STARTED   62   28 
COMPLETED   53   26 
NOT COMPLETED   9   2 
No consent                2                0 
QARC requirement not met                1                0 
Suspected metastatic disease                1                0 
No adenocarcinoma                1                0 
Low creatinine clearance                0                1 
Tumor size > 4cm                1                0 
Tumor fixed on digital exam                0                1 
No Absolute Neutrophil Count                2                0 
Biopsy done after registration                1                0 



  Baseline Characteristics

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
Original Dose Group External beam radiotherapy with megavoltage linear accelerators (≥ 6 MV) was delivered to a 3–4 field pelvis arrangement after CT-based simulation and computer-assisted treatment planning. Intensity-modulated radiotherapy was allowed. The original dose of radiotherapy was 1·8 Gy per day, 5 days a week for 5 weeks to a dose of 45 Gy to planning target volume 1, then a boost of 9 Gy to planning target volume 2 (defi ned as the gross tumour volume plus 2 cm) for a total dose of 54 Gy. This was accompanied by capecitabine (825 mg/m², twice daily, on days 1–14 and 22–35) and oxaliplatin (50 mg/m² on weeks 1, 2, 4, and 5). Surgery was done 4–8 weeks after completion of neoadjuvant chemoradiotherapy. Local excision was done using conventional transanal excision or transanal endoscopic microsurgery. Full-thickness excision of the tumour with a 1 cm surrounding margin of normal rectal wall was needed.
Revised Dose Group The radiotherapy was reduced to a total of 50·4 Gy by reducing the 9 Gy boost to 5·4 Gy, and capecitabine was reduced to 725 mg/m², twice daily, 5 days a week for 5 weeks. The dose of oxaliplatin was not changed. Surgery was done 4–8 weeks after completion of neoadjuvant chemoradiotherapy. Local excision was done using conventional transanal excision or transanal endoscopic microsurgery. Full-thickness excision of the tumour with a 1 cm surrounding margin of normal rectal wall was needed.
Total Total of all reporting groups

Baseline Measures
   Original Dose Group   Revised Dose Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 53   26   79 
Age 
[Units: Years]
Median (Full Range)
 62 
 (30 to 80) 
 63 
 (45 to 83) 
 62 
 (30 to 83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      20  37.7%      6  23.1%      26  32.9% 
Male      33  62.3%      20  76.9%      53  67.1% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   53   26   79 


  Outcome Measures

1.  Primary:   3-Year Disease-free Survival   [ Time Frame: Up to 3 years ]

2.  Secondary:   R0 Resection Rate (Negative Margin Rate)   [ Time Frame: At time of surgery ]

3.  Secondary:   Morbidity and Mortality Rate   [ Time Frame: Up to 30 days ]

4.  Secondary:   Rate of Pathologic Complete Response of the Primary Tumor   [ Time Frame: Up to 5 years ]

5.  Secondary:   Local Recurrence Rate   [ Time Frame: Up to 5 years ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Julio Garcia-Aguilar, MD
Organization: Memorial Sloan Kettering Cancer Center
phone: 212-639-5506
e-mail: garciaaj@mskcc.org


Publications of Results:
Other Publications:

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00114231     History of Changes
Other Study ID Numbers: ACOSOG-Z6041
ACOSOG-Z6041
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA076001 ( U.S. NIH Grant/Contract )
CDR0000433145 ( Registry Identifier: NCI Physician Data Query )
First Submitted: June 13, 2005
First Posted: June 14, 2005
Results First Submitted: February 21, 2018
Results First Posted: March 29, 2018
Last Update Posted: March 29, 2018