Prospective Randomized Phase III Study of Concurrent Capecitabine and Radiotherapy With or Without Oxaliplatin as Adjuvant Treatment for Stage II and III Rectal Cancer
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.
Observational
Observational Model: Cohort, Time Perspective: Prospective
3-year disease free survival rate
First day of treatment to the date of any recurrence
Yes
Yexiong Li, M.D.
Principal Investigator
CAMS
China: Food and Drug Administration
CAMS_rectal cancer_01
NCT00714077
April 2008
December 2013
Name | Location |
---|