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

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Trial Identification

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

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

Study ID: NCT00714077

Conditions

Rectal Neoplasms

Interventions

Study Description

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.