Metastatic Colorectal CancerNCT04852250
Centralized Tumour Board and Secondary Intervention Rate in mCRC
An observational study of Metastatic Colorectal Cancer and RAS Mutation, run by Ludwig-Maximilians - University of Munich.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer, RAS Mutation, Multidisciplinary Communication
- What is being tested?
- Virtual centralized multidisciplinary tumour board
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Treatment naive patients with RAS mutated metastatic colorectal cancer who are planned to receive FOLFOXIRI plus bevacizumab or patients who already received up to 4 cycles of FOLFOXIRI plus bevacizumab.
Who may be able to join
- Written informed consent to participate in the study
- Patients ≥ 18 years at the time of signing the informed consent
- Histologically confirmed (in primary tumour or metastasis) UICC stage IV metastatic adenocarcinoma of the colon or rectum (mCRC) with primarily unresectable metastases
- RAS mutant CRC (as determined by local pathology in tissue of primary tumour or metastasis)
- At least one measurable lesion according to RECIST version 1.1 in a CT/MRI scan performed within 28 days prior to start of systemic treatment (first cycle of induction treatment)
- ECOG performance status 0-1
Show all 10Show fewer
- Patients planned to receive chemotherapy with FOLFOXIRI plus bevacizumab as first-line treatment of metastatic disease. De-escalation of FOLFOXIRI to FOLFIRI or FOLFOX is allowed in case of toxicity.
- Patients can also be included if they had already received ≤ 4 cycles of induction/conversion therapy with FOLFOXIRI plus bevacizumab (including those patients in whom FOLFOXIRI has been de-escalated to FOLFIRI or FOLFOX due to toxicity) and the first restaging has not been conducted prior to randomization.
- Completion of adjuvant therapy for colorectal cancer > 3 months prior to start of systemic treatment (first cycle of induction treatment).
- Patient's ability for treatment with FOLFOXIRI and bevacizumab according to participating physician's judgement.
Who cannot join
- Pregnant or breast-feeding women. Females of childbearing potential (FCBPs) who do not practice adequate contraceptive measures as required according to SmPCs of the administered medicinal products.
- Contraindication to intensive chemotherapy with FOLFOXIRI plus bevacizumab
- Contraindications to treatment with 5-FU, oxaliplatin, folinic acid, irinotecan (FOLFOXIRI) and/or bevacizumab according to SmPCs of the administered medicinal products.
- Patients with confirmed cerebral metastasis. In case of clinical suspicion of brain metastasis, a cranial CT or MRI must be performed to rule out brain metastasis before study inclusion.
- Documentation of > 5 lung metastases (however, no limitation for the number of metastases in the liver)
- Isolated distant nodal metastasis, isolated peritoneal metastasis or isolated bone metastasis
- Limited legal capacity
Trial locations and contacts
No sites are listed yet.
About this study
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)
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.
Read more
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.
- Conditions
- Metastatic Colorectal Cancer, RAS Mutation, Multidisciplinary Communication, Secondary Intervention
- Being tested
- Virtual centralized multidisciplinary tumour board
- Keywords
- metastatic colorectal cancer, RAS mutation, Multidisciplinary Communication, Secondary Intervention
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual centralized multidisciplinary tumour boardOther
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
| Study group | Role | What they receive |
|---|---|---|
| FOLFOXIRI plus bevacizumab and centralized tumour board | Not described Receives: Other: Virtual centralized multidisciplinary tumour board | |
| FOLFOXIRI plus bevacizumab but no centralized tumour board | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Secondary intervention rate
Rate of patients in whom secondary interventions (e.g. resection, ablation treatment or combination of both) are performed in curative intent
Measured: 36 months
Secondary outcomes (4)
Objective response rate (ORR) according to RECIST 1.1
Measured: 36 months
Progression-free survival (PFS) rate
Measured: 6, 12 and 16 months
Overall survival (OS) rate
Measured: 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)
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start1 Jun 2021 (estimated)
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Responsible party
- Principal investigator, PD Dr. med. Volker Heinemann, Ludwig-Maximilians - University of Munich
- Investigators
- Volker Heinemann, Prof., Principal investigator, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852250
- Sponsor's protocol ID
- FIRE-7
- Status last verified
- Apr 2021
- First submitted
- 15 Apr 2021
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04852250
- Acronym / sponsor ID
- FIRE-7
- Conditions
- Metastatic Colorectal Cancer, RAS Mutation, Multidisciplinary Communication, Secondary Intervention
- Keywords
- metastatic colorectal cancer, RAS mutation, Multidisciplinary Communication, Secondary Intervention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOLFOXIRI plus bevacizumab and centralized tumour board | – | Other: Virtual centralized multidisciplinary tumour board |
| FOLFOXIRI plus bevacizumab but no centralized tumour board | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Treatment naive patients with RAS mutated metastatic colorectal cancer who are planned to receive FOLFOXIRI plus bevacizumab or patients who already received up to 4 cycles of FOLFOXIRI plus bevacizumab.
Key inclusion criteria (10 listed)
- Written informed consent to participate in the study
- Patients ≥ 18 years at the time of signing the informed consent
- Histologically confirmed (in primary tumour or metastasis) UICC stage IV metastatic adenocarcinoma of the colon or rectum (mCRC) with primarily unresectable metastases
- RAS mutant CRC (as determined by local pathology in tissue of primary tumour or metastasis)
- At least one measurable lesion according to RECIST version 1.1 in a CT/MRI scan performed within 28 days prior to start of systemic treatment (first cycle of induction treatment)
Key exclusion criteria (7 listed)
- Pregnant or breast-feeding women. Females of childbearing potential (FCBPs) who do not practice adequate contraceptive measures as required according to SmPCs of the administered medicinal products.
- Contraindication to intensive chemotherapy with FOLFOXIRI plus bevacizumab
- Contraindications to treatment with 5-FU, oxaliplatin, folinic acid, irinotecan (FOLFOXIRI) and/or bevacizumab according to SmPCs of the administered medicinal products.
- Patients with confirmed cerebral metastasis. In case of clinical suspicion of brain metastasis, a cranial CT or MRI must be performed to rule out brain metastasis before study inclusion.
- Documentation of > 5 lung metastases (however, no limitation for the number of metastases in the liver)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual centralized multidisciplinary tumour boardEvaluation 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 | Other | FOLFOXIRI plus bevacizumab and centralized tumour board |
Primary outcome
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
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Individual participant dataSharing planned: No
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CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Volker Heinemann, Prof. principal investigator
Ludwig-Maximilians - University of Munich
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer and RAS Mutation, run by Ludwig-Maximilians - University of Munich.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arndt Stahler, MD (+49 30 450 613478, arndt.stahler@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Secondary intervention rate (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2021; AzTrials last refreshed its copy on 6 Nov 2026.