Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Centralized Tumour Board and Secondary Intervention Rate in mCRC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04852250
Recruitment Status : Not yet recruiting
First Posted : April 21, 2021
Last Update Posted : April 21, 2021
Sponsor:
Collaborator:
Charité Universitätsmedizin, Department of Hematology, Oncology and Tumor Immunology
Information provided by (Responsible Party):
PD Dr. med. Volker Heinemann, Ludwig-Maximilians - University of Munich

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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. 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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Other
Time Perspective: Prospective
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
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Objective response rate (ORR) according to RECIST 1.1 [ Time Frame: 36 months ]
  2. Progression-free survival (PFS) rate [ Time Frame: 6, 12 and 16 months ]
  3. Overall survival (OS) rate [ Time Frame: 6, 12 and 16 months ]
  4. Type, incidence, relatedness, and severity of adverse events with severity ≥ Grad 3 (severity according to NCI CTCAE version 5.0) [ Time Frame: 60 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  1. Written informed consent to participate in the study
  2. Patients ≥ 18 years at the time of signing the informed consent
  3. Histologically confirmed (in primary tumour or metastasis) UICC stage IV metastatic adenocarcinoma of the colon or rectum (mCRC) with primarily unresectable metastases
  4. RAS mutant CRC (as determined by local pathology in tissue of primary tumour or metastasis)
  5. 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)
  6. ECOG performance status 0-1

  7. 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.

  8. Completion of adjuvant therapy for colorectal cancer > 3 months prior to start of systemic treatment (first cycle of induction treatment).
  9. Patient's ability for treatment with FOLFOXIRI and bevacizumab according to participating physician's judgement.

Exclusion Criteria:

  1. 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.
  2. Contraindication to intensive chemotherapy with FOLFOXIRI plus bevacizumab
  3. Contraindications to treatment with 5-FU, oxaliplatin, folinic acid, irinotecan (FOLFOXIRI) and/or bevacizumab according to SmPCs of the administered medicinal products.
  4. 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.
  5. Documentation of > 5 lung metastases (however, no limitation for the number of metastases in the liver)
  6. Isolated distant nodal metastasis, isolated peritoneal metastasis or isolated bone metastasis
  7. Limited legal capacity
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Arndt Stahler, MD +49 30 450 613478 arndt.stahler@charite.de
Contact: Matthias Wolff +49 89 4400 72208 matthias.wolff@med.uni-muenchen.de

Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Charité Universitätsmedizin, Department of Hematology, Oncology and Tumor Immunology
Investigators
Layout table for investigator information
Principal Investigator: Volker Heinemann, Prof. Ludwig-Maximilians - University of Munich
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: PD Dr. med. Volker Heinemann, Principal Investigator, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT04852250    
Other Study ID Numbers: FIRE-7
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: April 21, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PD Dr. med. Volker Heinemann, Ludwig-Maximilians - University of Munich:
metastatic colorectal cancer
RAS mutation
Multidisciplinary Communication
Secondary Intervention
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes