Safety Study of Capecitabine With Radiation in Elderly Rectal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jing Jin, M.D., Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01584544
First received: April 20, 2012
Last updated: April 17, 2015
Last verified: April 2015
Results First Received: April 7, 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
Interventions: Drug: capecitabine
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
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
1000mg

capecitabine 1000mg/m2/d d1-14, d22-25 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

1350mg

capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.

Capecitabine: oral pills, 1350mg/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

1650mg

capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.

Capecitabine: oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation


Participant Flow:   Overall Study
    1000mg     1200mg     1350mg     1500mg     1650mg  
STARTED     3     6     6     3     6  
COMPLETED     3     6     6     3     6  
NOT COMPLETED     0     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 1000mg/m2/d d1-14, d22-25 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

1350mg

capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.

Capecitabine: oral pills, 1350mg/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

1650mg

capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.

Capecitabine: oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation

Total Total of all reporting groups

Baseline Measures
    1000mg     1200mg     1350mg     1500mg     1650mg     Total  
Number of Participants  
[units: participants]
  3     6     6     3     6     24  
Age  
[units: participants]
           
<=18 years     0     0     0     0     0     0  
Between 18 and 65 years     0     0     0     0     0     0  
>=65 years     3     6     6     3     6     24  
Age  
[units: years]
Median (Full Range)
  77    (75 to 82)     77    (75 to 84)     78    (75 to 82)     76    (76 to 77)     78    (76 to 79)     78    (75 to 84)  
Gender  
[units: participants]
           
Female     1     3     2     1     4     11  
Male     2     3     4     2     2     13  
Region of Enrollment  
[units: participants]
           
China     3     6     6     3     6     24  



  Outcome Measures

1.  Primary:   Number of Participants Experienced Dose Limited Toxicity   [ Time Frame: up to 7 weeks from start of the treatment ]


  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: Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
phone: 8601087788122
e-mail: jingjin1025@163.com


Publications:


Responsible Party: Jing Jin, M.D., Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01584544     History of Changes
Other Study ID Numbers: CH-GI-024
Study First Received: April 20, 2012
Results First Received: April 7, 2015
Last Updated: April 17, 2015
Health Authority: China: Food and Drug Administration