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Report for Clinical Trial NCT04317599

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Retrospective Non Interventional Study on First Line Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer (mCRC)

The presence of a BRAFV600E mutation is considered a marker of poor prognosis in patients with mCRC, and findings from clinical trials have largely remained inconclusive regarding the efficacy of first line treatments for BRAF-mutant mCRC patients. In the absence of targeted/specific treatment for BRAF-mutant mCRC, treatment practices can vary based on local practices and guidelines. There is, therefore, an unmet need to document the current practices for first-line treatment of BRAF-mutant mCRC, and their effectiveness and safety in a real-world setting. This real-world, multicenter non-interventional study (NIS) will describe the treatment patterns, effectiveness and safety of current treatment regimens in BRAFV600E mutant mCRC patients in Europe, with the aim to put the clinical study findings of the ongoing Phase 2, single-arm, open label trial (ANCHOR) into context of the current treatment landscape excluding investigational therapies. Additionally, the NIS output may be used to support future health technology assessment submissions and publications.

NCT04317599 BRAF V600E Mutation Positive Metastatic Colorectal Cancer
MeSH:Colorectal Neoplasms
HPO:Neoplasm of the large intestine

1 Interventions

Name: Non Interventional study

Description: Non Interventional study
Type: Other
Group Labels: 1

Non interventional


Primary Outcomes

Description: Agent or combination of agents received, Duration of treatment, Maintenance therapy (if any)

Measure: First-line Systemic anticancer therapy (SACT) treatment patterns in BRAFV600E mutant mCRC patients

Time: time of treatment initiation (for mCRC) until the time of first documented disease progression, treatment discontinuation or switch, whichever is earlier or end of study observation period up to 31 December 2020

Secondary Outcomes

Description: Description of the demographic and clinical profile of patients at the time of treatment initiation (for mCRC)

Measure: Demographic and clinical characteristics

Time: from the date of the start of first-line treatment for mCRC until the end of the observation period (date of death or last day of study observation period for patients alive at the time of data abstraction) up to 31 December 2020

Description: the length of time between initiation of first-line treatment for mCRC and the first documented disease progression

Measure: Progression-free Survival (PFS)

Time: from the date of the start of first-line treatment for mCRC until the end of the observation period (date of death or last day of study observation period for patients alive at the time of data abstraction) up to 31 December 2020

Description: length of time between first-line treatment initiation (for mCRC) and death (due to any cause)

Measure: Overall Survival (OS)

Time: from the date of the start of first-line treatment for mCRC until the end of the observation period (date of death or last day of study observation period for patients alive at the time of data abstraction) up to 31 December 2020

Description: number of complete response (CR) or partial response (PR)

Measure: Overall Response rate (ORR)

Time: from the date of the start of first-line treatment for mCRC until the end of first-line treatment up to 31 December 2020

Description: the length of time between initiation of first-line treatment for mCRC and documented disease progression (or start of subsequent Line Of Treatment (LOT), if disease progression is not well documented in patient medical record), treatment discontinuation or switch to another treatment (defined as change from one treatment regimen to another treatment regimen, e.g., change from FOLFOX-based regimen to FOLFIRI or irinotecan-based regimen)

Measure: Time to treatment cessation

Time: from the date of the start of first-line treatment for mCRC until the documented disease progression up to 31 December 2020

Time Perspective: Retrospective

Cohort


There is one SNP

SNPs


1 V600E

BRAF V600E Mutation Positive Metastatic Colorectal Cancer Colorectal Neoplasms This retrospective, multi-center longitudinal study on BRAFV600E mutant mCRC patients will be conducted in Europe to characterize the first-line treatment patterns. --- V600E ---



HPO Nodes


HPO: