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FFCD 1605- OPTIPRIME: A phase II study evaluating FOLFOX + panitumumab according to a ‘stop-and-go’ strategy with a reintroduction loop after progression on fluoropyrimidine as maintenance treatment, as the first line in patients with metastatic colorectal adenocarcinoma without a RAS mutation

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518740-20-00
Acronym
FFCD 1605 OPTIPRIME
Enrollment
118
Registered
2024-11-13
Start date
2018-04-26
Completion date
2025-05-19
Last updated
2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastatic colorectal adenocarcinoma

Brief summary

Disease control duration.

Detailed description

Progression-free survival 1 (PFS1 or PFS), Progression-free survival 2 (PFS 2), Successive progression-free survivals (PFS3), 4 (PFS4), etc, The best tumour response, The early response rate at 6 weeks, The depth of response, Overall survival, Quality of life (EORTC QLQ C-30), The dose intensity, The adverse events, The predictive value of early evolution, The predictive value of the appearance of resistance mutation(s)

Interventions

DRUGXeloda 150 mg film-coated tablets
DRUGFolinic acid (as calcium folinate) 10 mg/ml solution for injection/infusion
DRUGELOXATINE 5 mg/ml
DRUGsolution à diluer pour perfusion
DRUGVectibix 20 mg/ml concentrate for solution for infusion
DRUGFLUOROURACILE TEVA 1000 mg/20 ml

Sponsors

Fondation Franc.Cancerologie Digestive
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Disease control duration.—

Secondary

MeasureTime frame
Progression-free survival 1 (PFS1 or PFS), Progression-free survival 2 (PFS 2), Successive progression-free survivals (PFS3), 4 (PFS4), etc, The best tumour response, The early response rate at 6 weeks, The depth of response, Overall survival, Quality of life (EORTC QLQ C-30), The dose intensity, The adverse events, The predictive value of early evolution, The predictive value of the appearance of resistance mutation(s)—

Countries

Belgium, France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026