Adjuvant Treatment of Concurrent RT and CAPOX or Capecitabine Alone for Stage II and III Rectal Cancer

• Conditions: Rectal Neoplasms

• Registration Number: NCT00714077
• Lead Sponsor: Chinese Academy of Medical Sciences

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 capecitabine,for stage II and III rectal cancer

* To compare the toxicity profile between the two different concurrent chemoradiotherapy regimens.

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 standard treatment, 5-year local failure rate and distant metastasis rate is 10% and around 35%, respectively. Capecitabine, an analog of 5-fluoruracil (5FU), was demonstrated to have similar treatment results compared to 5-FU, but have much lower toxicities. Oxaliplatin based chemotherapy, also showed a better disease-free survival rate compared with 5-FU based-regimen. So far, some Phase I/II studies have shown the safety and preliminary results of either concurrent chemotherapy of capecitabine or oxaliplatin and capecitabine. The long-term results in comparison of capecitabine concurrent chemoradiotherapy with oxaliplatin/capecitabine concurrent chemoradiotherapy need to be further analyzed.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-07-09
• Study First Submitted QC: 2008-07-10
• Study First Posted: 2008-07-14
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-15
• Last Update Posted: 2016-02-17
• Primary Completion: 2018-01
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 570

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3-year disease free survival rate	the day of surgery to the date of the event

Secondary Outcome Measures

Name	Time	Method
overall survival rate	the day of surgery to the date of death or last follow-up
cumulative incidence of local recurrence	the day of surgery to the date of local recurrence
cumulative incidence of distant metastasis	the day of surgery to the date of distant metastasis
compliance	during adjuvant radiotherapy and chemotherapy
safety	the day of randomization to the date of death or last follow-up

Trial Locations

Locations (1)

Jing Jin; 🇨🇳 Beijing, Beijing, China