Status:
UNKNOWN
Adjuvant Treatment of Concurrent RT and CAPOX or Capecitabine Alone for Stage II and III Rectal Cancer
Lead Sponsor:
Chinese Academy of Medical Sciences
Collaborating Sponsors:
Zhejiang Cancer Hospital
Cancer Hospital of Guizhou Province
Conditions:
Rectal Neoplasms
Eligibility:
All Genders
18-75 years
Brief Summary
The purpose of this study is: * To compare the long-term of survival and local/regional control between the two postoperative concurrent chemoradiotherapy regimens: capecitabine vs. oxaliplatin and c...
Detailed Description
Adjuvant 5-FU based concurrent chemoradiotherapy and chemotherapy is the standard care for locally advanced stage II-III rectal cancer, based on several randomized Phase III clinical trials. With this...
Eligibility Criteria
Inclusion
- 18-75 years old,male or female
- R0 surgery
- Pathologically approved as stage II or stage III
- Enrolled within 6 months from the date of surgery
- Upper border of tumor before surgery was under L5
- KPS\>70% or ECOG 0-2
- No prior radiotherapy in the past 6 months
- Received chemotherapy no more than 4 cycles after surgery
- HGB\>100 g/L, WBC≥3.5x109 /L, PLT≥100x109 /L; CR\<1.5 x Upper normality，TB\<2.5 X Upper normality，AST or ALT\<2.5 x Upper normality，AKP\<2.5 X Upper normality
- Signed consent
Exclusion
- Other malignancies simultaneously except in situ cervix or nonmelanoma skin cancer
- Pregnancy or in lactation
- HGB\<100 g/L, WBC\<3.5x109 /L, PLT\<100x109 /L; CR≥1.5 x Upper normality，TB≥2.5 X Upper normality，AST or ALT≥2.5 x Upper normality，AKP≥2.5 X Upper normality
Key Trial Info
Start Date :
April 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2018
Estimated Enrollment :
570 Patients enrolled
Trial Details
Trial ID
NCT00714077
Start Date
April 1 2008
End Date
June 1 2018
Last Update
February 17 2016
Active Locations (2)
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1
Jing Jin
Beijing, Beijing Municipality, China, 100021
2
Jing Jin
Beijing, Beijing Municipality, China, 100021