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Report for Clinical Trial NCT04117945

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Randomized Phase II Study of Regorafenib Followed by Anti-EGFR Monoclonal Antibody Therapy Versus the Reverse Sequencing for Metastatic Colorectal Cancer Patients Previously Treated With Fluoropyrimidine, Oxaliplatin and Irinotecan (REVERCE II)

This phase II trial how well regorafenib and anti-EGFR therapy (cetuximab or panitumumab) works for the treatment of patients with colorectal cancer that cannot be removed by surgery (unresectable), has spread to nearby tissue or lymph nodes (locally advanced), or has spread to other places in the body (metastatic). Regorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab or panitumumab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The purpose of this research study is to compare the effects, good and/or bad, of taking regorafenib follow by cetuximab or panitumumab, to those that receive cetuximab or panitumumab before regorafenib.

NCT04117945 BRAF V600E Negative KRAS Gene Mutation Negative Locally Advanced Unresectable Colorectal Adenocarcinoma Metastatic Colorectal Adenocarcinoma NRAS Gene Mutation Negative Stage III Colorectal Cancer AJCC v8 Stage IIIA Colorectal Cancer AJCC v8 Stage IIIB Colorectal Cancer AJCC v8 Stage IIIC Colorectal Cancer AJCC v8 Stage IV Colorectal Cancer AJCC v8 Stage IVA Colorectal Cancer AJCC v8 Stage IVB Colorectal Cancer AJCC v8 Stage IVC Colorectal Cancer AJCC v8
MeSH:Colorectal Neoplasms Adenocarcinoma
HPO:Neoplasm of the large intestine

4 Interventions

Name: Cetuximab

Description: Given IV
Type: Biological
Group Labels: 1

Arm B (cetuximab, panitumumab, irinotecan)

Name: Irinotecan

Description: Given IV
Type: Drug
Group Labels: 1

Arm B (cetuximab, panitumumab, irinotecan)

Name: Panitumumab

Description: Given IV
Type: Biological
Group Labels: 1

Arm B (cetuximab, panitumumab, irinotecan)

Name: Regorafenib

Description: Given PO
Type: Drug
Group Labels: 1

Arm A (regorafenib)


Primary Outcomes

Description: The median OS and 95% confidence intervals in each arm will be reported.

Measure: Overall survival (OS)

Time: Up to 3 years

Secondary Outcomes

Description: The median first PFS and 95% confidence intervals in each arm will be reported.

Measure: First progression-free survival (PFS)

Time: Up to 3 years

Description: The median second PFS and 95% confidence intervals in each arm will be reported.

Measure: Second PFS

Time: Up to 3 years

Description: The median PFS while on sequential treatment and 95% confidence intervals in each arm will be reported.

Measure: Sequential treatment PFS

Time: Up to 3 years

Description: Point estimates and the corresponding 95% confidence intervals for the true success proportions in each arm will be reported.

Measure: Objective response rate

Time: Up to 3 years

Description: Point estimates and the corresponding 95% confidence intervals for the true success proportions will be reported.

Measure: Sequential treatment objective response rate

Time: Up to 3 years

Description: The number of patients who experience a grade 3 or higher adverse event (Common Terminology Criteria for Adverse Events [CTCAE] version [v.] 5.0), regardless of attribution, will be reported by arm.

Measure: Incidence of adverse events

Time: Up to 3 years

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 V600E

opinion, makes the subject unsuitable for trial participation BRAF V600E Negative KRAS Gene Mutation Negative Locally Advanced Unresectable Colorectal Adenocarcinoma Metastatic Colorectal Adenocarcinoma NRAS Gene Mutation Negative Stage III Colorectal Cancer AJCC v8 Stage IIIA Colorectal Cancer AJCC v8 Stage IIIB Colorectal Cancer AJCC v8 Stage IIIC Colorectal Cancer AJCC v8 Stage IV Colorectal Cancer AJCC v8 Stage IVA Colorectal Cancer AJCC v8 Stage IVB Colorectal Cancer AJCC v8 Stage IVC Colorectal Cancer AJCC v8 Colorectal Neoplasms Adenocarcinoma PRIMARY OBJECTIVE: I. To compare the overall survival between evaluable patients who were randomized to receive regorafenib followed by anti-EGFR monoclonal antibody therapy compared to those that receive anti-EGFR monoclonal antibody followed by regorafenib. --- V600E ---



HPO Nodes


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