Clinical Trials Logo

Clinical Trial Summary

The FIRE-4 study aims to define a treatment concept for patients with RAS wild-type tumours, optimised with regard to overall survival. The first-line treatment will be conducted with FOLFIRI plus cetuximab, which resulted in a significantly prolonged overall survival versus bevacizumab in the FIRE-3 study. Following initial progression (PD1) it is recommended that the treatment be continued with FOLFOX plus bevacizumab, as this concept led to significantly prolonged survival in the E3200 study. Owing to the encouraging results of the Santini study , a cetuximab rechallenge in combination with irinotecan-based chemotherapy is to be performed as part of the third-line treatment in patients who showed a response defined according to RECIST 1.1 during the first-line treatment (tumour diameter < -30%) or presented with stable tumour disease for at least 6 months (tumour diameter +20 to -30%). The concept of the ideal sequence has not yet been studied to date in a clinical trial.


Clinical Trial Description

The study will begin with FPFV: (first study visit of the first patient, signing the declaration of consent to participate in the study): scheduled for the 4th quarter of 2014 Patient recruitment: 36 months Treatment duration per patient: Until the time of progression under the third-line treatment at the latest. Anticipated individual duration of treatment: 24 months (for patients who undergo all three treatment lines -included in part 1), or 6 months in patients who only receive third line treatment (included directly in part 2) Duration of follow-up after the end of treatment: For all patients, until death or for at least 1 year following final termination of any study treatment regardless of the treatment line. In so doing, the follow-up period for patients included in part 1 of the study will be conducted for a maximum of 5 years from the time of randomisation 1; and for patients included in only part 2 of the study (third-line treatment), for a maximum of 3 years from the date of randomisation 2. End of the study: last follow-up visit of the last study patient scheduled for the 4th quarter of 2020 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02934529
Study type Interventional
Source Ludwig-Maximilians - University of Munich
Contact
Status Active, not recruiting
Phase Phase 3
Start date March 2015
Completion date December 2024

See also
  Status Clinical Trial Phase
Completed NCT01228734 - A Trial to Compare Oxaliplatin, Folinic Acid (FA) and 5-Fluorouracil (5FU) Combination Chemotherapy (FOLFOX-4) With or Without Cetuximab in the 1st Line Treatment of Metastatic Colorectal Cancer (mCRC) in Chinese Rat Sarcoma Viral Oncogene Homolog (RAS) Wild-type Patients Phase 3
Completed NCT05178745 - A Prospective Observational Cohort Study Evaluating Resection Rate in Patients With Metastatic Colorectal Cancer Treated With Aflibercept in Combination With FOLFIRI - Observatoire résection
Completed NCT01591421 - P13Kinase Inhibitor BKM120 in Combination With Panitumumab in Metastatic/Advanced RAS-Wild Type Colorectal Cancer. Phase 1/Phase 2
Withdrawn NCT05412706 - Niraparib Maintenance Treatment in mCRC With a Partial o Complete Response After Oxaliplatin-based Induction Therapy Phase 2
Withdrawn NCT04430985 - FOLFOX + Immunotherapy With Intrahepatic Oxaliplatin for Patients With Metastatic Colorectal Cancer Phase 2
Withdrawn NCT03182894 - Epacadostat in Combination With Pembrolizumab and Azacitidine in Subjects With Metastatic Colorectal Cancer Phase 1/Phase 2
Recruiting NCT05725200 - Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer Phase 2
Terminated NCT03176264 - PDR001 in Combination With Bevacizumab and mFOLFOX6 as First Line Therapy in Patients With Metastatic MSS Colorectal Cancer Phase 1
Completed NCT04866290 - HepaSphereâ„¢ Microspheres Prospective Registry
Not yet recruiting NCT06425133 - Regorafenib in Combination With Multimodal Metronomic Chemotherapy for Chemo-resistant Metastatic Colorectal Cancers Phase 2
Not yet recruiting NCT05531045 - 18FFDG PET/CT for Early Evaluation of Chemotherapy Efficacy in Metastatic Colic Adenocarcinoma
Withdrawn NCT03982173 - Basket Trial for Combination Therapy With Durvalumab (Anti-PDL1) (MEDI4736) and Tremelimumab (Anti-CTLA4) in Patients With Metastatic Solid Tumors Phase 2
Completed NCT02906059 - Study of Irinotecan and AZD1775, a Selective Wee 1 Inhibitor, in RAS or BRAF Mutated, Second-line Metastatic Colorectal Cancer Phase 1
Active, not recruiting NCT02575378 - Maintenance Treatment With Capecitabine Metronomic Chemotherapy and Chinese Traditional Medicine in Metastatic Colorectal Cancer Phase 4
Withdrawn NCT02535988 - Abscopal Effect for Metastatic Colorectal Cancer Phase 2
Recruiting NCT02848807 - Chemotherapy-related Toxicity, Nutritional Status and Quality of Life N/A
Active, not recruiting NCT02077868 - Evaluation of MGN1703 Maintenance Treatment in Patients With mCRC With Tumor Reduction During Induction Treatment Phase 3
Completed NCT02414009 - Study to Compare CAPTEM vs FOLFIRI as Second Line Treatment in Advanced, Colorectal Cancer Patients Phase 2
Active, not recruiting NCT01949194 - Study to Determine the Efficacy of Regorafenib in Metastatic Colorectal Cancer Patients and to Discover Biomarkers Phase 2
Withdrawn NCT01915472 - A Phase II Study of IMMU 130 in Patients With Metastatic Colorectal Cancer Phase 2