Study of Postoperative Concurrent Chemo-radiation With Capecitabine in Elderly Rectal Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jing Jin, M.D., Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01268943
First received: December 28, 2010
Last updated: March 17, 2015
Last verified: March 2015
Results First Received: March 5, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Rectal Neoplasms
Intervention: Drug: Capecitabine

  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
Between October 2010 and November 2013, 18 patients were enrolled in a hospital.

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
1000mg

capecitabine 1000mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.

Capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.

1200mg

capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.

Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.

1400mg

capecitabine 1400mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.

Capecitabine: oral pills, 1400mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.

1500mg

capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.

Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.


Participant Flow:   Overall Study
    1000mg     1200mg     1400mg     1500mg  
STARTED     6     3     3     6  
COMPLETED     6     3     3     6  
NOT COMPLETED     0     0     0     0  



  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
1000mg capecitabine 500mg/m2 twice daily. 6 patients enrolled
1200mg capecitabine 600mg/m2 twice daily. 3 patients enrolled
1400mg capecitabine 700mg/m2 twice daily. 3 patients enrolled
1500mg capecitabine 750mg/m2 twice daily. 6 patients enrolled
Total Total of all reporting groups

Baseline Measures
    1000mg     1200mg     1400mg     1500mg     Total  
Number of Participants  
[units: participants]
  6     3     3     6     18  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     0     0     0     0     0  
>=65 years     6     3     3     6     18  
Age  
[units: years]
Mean (Full Range)
  75.5   (72 to 83)     73.7   (73 to 75)     75.7   (71 to 81)     73.5   (70 to 78)     74.5   (70 to 83)  
Gender  
[units: participants]
         
Female     1     0     0     4     5  
Male     5     3     3     2     13  



  Outcome Measures

1.  Primary:   Dose Related Toxicity   [ Time Frame: up to 9 weeks ]


  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: Dr. Jing Jin
Organization: Chinese Academic Medical Sciences
phone: 010-87788503
e-mail: tangyu.pumc@gmail.com


Publications:


Responsible Party: Jing Jin, M.D., Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01268943     History of Changes
Other Study ID Numbers: CH-GI-013
Study First Received: December 28, 2010
Results First Received: March 5, 2015
Last Updated: March 17, 2015
Health Authority: China: Food and Drug Administration