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Randomized three arm phase III trial on induction treatment with a fluoropyrimidine-, oxaliplatin- and bevacizumab-based chemotherapy for 24 weeks followed by maintenance treatment with a fluoropyrimi...

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-007974-39

Randomized three arm phase III trial on induction treatment with a fluoropyrimidine-, oxaliplatin- and bevacizumab-based chemotherapy for 24 weeks followed by maintenance treatment with a fluoropyrimidine and bevacizumab vs. bevacizumab alone vs. no maintenance treatment and reinduction in case of progression for first-line treatment of patients with metastatic colorectal cancer

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Extrait

Investigating the efficacy of maintenance and reinduction treatment or no treatment and watchful waiting in subjects with inoperable or irresectable and non-progressive metastatic colorectal cancer after first line induction treatment for 24 weeks with a fluoropyrimidine-, oxaliplatin- and bevacizumab-based chemotherapy. The maintenance treatment with capecitabine or 5-FU/folinic acid and bevacizumab will be compared with a maintenance treatment with bevacizumab alone or no maintenance treatment. Reinduction treatment will be done in case of progression. Primary end-point: Time to failure of maintenance and reinduction treatment strategy measured from randomization.

Critère d'inclusion

  • Histologically confirmed and inoperable or irresectable metastatic colorectal cancer (stage IV)

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