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

Rectal Neoplasms Clinical Trial

Official title:
Prospective Randomized Phase III Study of Concurrent Capecitabine and Radiotherapy With or Without Oxaliplatin as Adjuvant Treatment for Stage II and III Rectal Cancer

Clinical Trial 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.

Clinical Trial 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00714077
Study type Observational
Source Chinese Academy of Medical Sciences
Contact Jing Jin, M.D.
Phone 861087788280
Email jingjin1025@163.com
Status Recruiting
Phase Phase 3
Start date April 2008
Completion date June 2018
View Details
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