Kurzfassung

Primary study goal:
Prospective examination of the total survival from randomisation in third-line therapy (OS3) under a Cetuximab reexposure versus an anti-EGFR free therapy in patients who have responded to a first-line therapy with Cetuximab and FOLFIRI with CR, PR or SD 6 months.
Secondary study objectives:
Response rate ORR1, 2 and 3 (Evaluation of ORR1 andORR2 only if the study inclusion has already taken place in
Part 1 of the study)
Progression-free time PFS1, 2 and 3 (evaluation ofPFS1...Primary study goal:
Prospective examination of the total survival from randomisation in third-line therapy (OS3) under a Cetuximab reexposure versus an anti-EGFR free therapy in patients who have responded to a first-line therapy with Cetuximab and FOLFIRI with CR, PR or SD ≥ 6 months.
Secondary study objectives:
Response rate ORR1, 2 and 3 (Evaluation of ORR1 andORR2 only if the study inclusion has already taken place in
Part 1 of the study)
Progression-free time PFS1, 2 and 3 (evaluation ofPFS1 and PFS2 only if the study inclusion has already taken place in
Part 1 of the study)
Overall survival (OS1) starting from randomisation infirst-line therapy (evaluation only if the study inclusion has already taken place in
Part 1 of the study)
Investigation of early tumor reduction (early tumorShrinkage ") and the depth of remission in first and third line therapy
Investigation of molecular biomarkers for predictionOf sensitivity and secondary resistance of an anti-EGFR
therapy with Cetuximab (including tumor biopsies and
liquid biopsies from blood samples)
Prospective validation of a biomarker score» weiterlesen» einklappen