CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 823 enrolled
Drug / intervention
oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab +1 moredrug
Likely dose
Not stated in record
Key inclusion· 6
  • Age 20-79 years at informed consent
  • Unresectable adenocarcinoma of the large intestine (excluding appendix and anal canal)
  • Measurable or evaluable lesion(s) per RECIST v1.1 (not essential)
  • No prior chemotherapy for colorectal cancer, except adjuvant fluoropyrimidine >24 weeks prior (no oxaliplatin)
Key exclusion· 8
  • Known or strongly suspected brain metastasis
  • Synchronous or metachronous cancers with disease-free period ≤5 years (excluding colorectal cancer and certain mucosal cancers)
  • Body cavity fluid requiring treatment (pleural effusion, ascites, pericardial effusion)
  • Radiotherapy within 4 weeks prior to enrollment (except pain relief for bone metastases)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02394795
NCT02394795Phase 3Completed

A Phase III, Randomized, Controlled Study of mFOLFOX6 + Bevacizumab Combination Therapy Versus mFOLFOX6 + Panitumumab Combination Therapy in Chemotherapy-naive Patients With KRAS/NRAS Wild-type, Incurable/Unresectable, Advanced/Recurrent Colorectal Cancer

Takeda·interventional·Posted Mar 20, 2015·Updated Nov 1, 2023

In Brief

A Phase 3 clinical trial evaluating oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab and oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, bevacizumab for Colorectal Cancer. Completed, enrolled 823 participants across 155 sites.

Detailed Summary

The purpose of this study is to verify the efficacy of mFOLFOX6 + panitumumab combination therapy and mFOLFOX6 + bevacizumab combination therapy in first-line treatment of chemotherapy-naive patients with KRAS/NRAS wild-type, incurable/unresectable, advanced/recurrent colorectal cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 20, 2015
Enrollment StartMay 29, 2015
Primary CompletionJan 14, 2022
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 11.3 years ago

Interventions

oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumabdrug

oxaliplatin (OXA), levofolinate calcium (l-LV), panitumumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion

oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, bevacizumabdrug

oxaliplatin (OXA), levofolinate calcium (l-LV), bevacizumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion