Centralized Tumour Board and Secondary Intervention Rate in mCRC
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|ClinicalTrials.gov Identifier: NCT04852250|
Recruitment Status : Not yet recruiting
First Posted : April 21, 2021
Last Update Posted : April 21, 2021
This is a randomised, multicentre observational study in patients suffering from RAS mutant mCRC with primarily unresectable metastases, who are planned to be treated with FOLFOXIRI and bevacizumab or who have already received ≤ four cycles FOLFOXIRI and bevacizumab as first-line treatment of metastatic disease. The patients are randomised in a 1:1 ratio to compare the rate of patients in whom secondary interventions (e.g. resection, ablation) are performed in curative intent when secondary intervention options are assessed by a multidisciplinary centralized tumour board (Arm A) versus when secondary intervention options are not assessed by a multidisciplinary centralized tumour board (Arm B).
All patients evaluated in the study will receive chemotherapy with FOLFOXIRI plus bevacizumab. After this induction/conversion therapy, imaging (CT or MRI) will be performed to evaluate resectability. In Arm A, a multidisciplinary, centralized tumour board will assess options of secondary intervention to be performed in the context of a generally curative treatment approach.
If there are secondary intervention options according to the judgement of the centralized tumour board, they will be listed in their respective sequence and the assessment will be communicated to the participating physician or his/her deputy at the study center. The decision, whether or not any secondary intervention is performed as recommended by the centralized tumour board as well as the kind of interventional procedures is up to the discretion of the treating physicians and surgeons of each patient. Any secondary intervention is recorded.
Evaluating the primary endpoint, the first interventions performed in one organ (e.g. liver) are rated when performed in a generally curative context (e.g. even in the presence of lung metastases that need to be approached in a further intervention).
In Arm B, no centralized tumour board will be integrated in to clinical decision making and patients will be treated according to institutional guidelines.
The number of treatment cycles with FOLFOXIRI and bevacizumab will be according to local clinical routine and medical guidelines, recommended are 8 to 12 cycles FOLFOXIRI in combination with bevacizumab, followed by a maintenance therapy with fluoropyrimidine (FP) plus bevacizumab until progression.
|Condition or disease||Intervention/treatment|
|Metastatic Colorectal Cancer RAS Mutation Multidisciplinary Communication Secondary Intervention||Other: Virtual centralized multidisciplinary tumour board|
|Study Type :||Observational|
|Estimated Enrollment :||130 participants|
|Official Title:||Impact of a Centralized Tumour Board on Secondary Intervention Rate in Patients With RAS Mutant Metastatic Colorectal Cancer After First-line Treatment With FOLFOXIRI Plus Bevacizumab (FIRE-7)|
|Estimated Study Start Date :||June 1, 2021|
|Estimated Primary Completion Date :||March 31, 2023|
|Estimated Study Completion Date :||March 31, 2025|
|FOLFOXIRI plus bevacizumab and centralized tumour board||
Other: Virtual centralized multidisciplinary tumour board
Evaluation of radiologic imaging and general condition by a multidisciplinary expert gremium to recommend either secondary intervention or resection of metastases or continuation of systemic treatment
|FOLFOXIRI plus bevacizumab but no centralized tumour board|
- Secondary intervention rate [ Time Frame: 36 months ]Rate of patients in whom secondary interventions (e.g. resection, ablation treatment or combination of both) are performed in curative intent
- Objective response rate (ORR) according to RECIST 1.1 [ Time Frame: 36 months ]
- Progression-free survival (PFS) rate [ Time Frame: 6, 12 and 16 months ]
- Overall survival (OS) rate [ Time Frame: 6, 12 and 16 months ]
- Type, incidence, relatedness, and severity of adverse events with severity ≥ Grad 3 (severity according to NCI CTCAE version 5.0) [ Time Frame: 60 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04852250
|Contact: Arndt Stahler, MD||+49 30 450 firstname.lastname@example.org|
|Contact: Matthias Wolff||+49 89 4400 email@example.com|
|Principal Investigator:||Volker Heinemann, Prof.||Ludwig-Maximilians - University of Munich|