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Centralized Tumour Board and Secondary Intervention Rate in mCRC

NCT04852250 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2021-04-21

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Charité Universitätsmedizin, Department of Hematology, Oncology and Tumor Immunology

    collaborator UNKNOWN

  • Ludwig-Maximilians - University of Munich

    lead OTHER

Principal Investigators

  • Volker Heinemann, Prof. · Ludwig-Maximilians - University of Munich

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2023-03-31
Completion
2025-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04852250 on ClinicalTrials.gov