Spots Global Cancer Trial Database for IMPROVE Intervention Trial Implementing Non-invasive Circulating Tumor DNA Analysis to Optimize the Operative and Postoperative Treatment for Patients With Colorectal Cancer

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Trial Identification

Brief Title: IMPROVE Intervention Trial Implementing Non-invasive Circulating Tumor DNA Analysis to Optimize the Operative and Postoperative Treatment for Patients With Colorectal Cancer

Official Title: Implementing Non-invasive Circulating Tumor DNA Analysis to Optimize the Operative and Postoperative Treatment for Patients With Colorectal Cancer

Study ID: NCT03748680

Conditions

Colorectal Cancer

Circulating Tumor DNA

Adjuvant Chemotherapy

Progression Free Survival

Interventions

Capox (or FOLFOX) including flouropyrimidine and oxaliplatin combination chemotherapy

Intensified Follow-up Schedule

Study Description

Brief Summary: A open label 1:1 randomized phase II exploratory study investigating adjuvant therapy in patients with molecular biologically detectable residual disease after primary resection for localized colorectal tumors.

Detailed Description: The main clinical hypothesis is that patients having undergone radical resection from CRC do not present with detectable tumor DNA in the plasma, whereas patients with detectable tumor DNA two weeks' post surgery have residual microscopic disease, and consequently a high risk of diseases recurrence which can be prevented with adjuvant chemotherapy. The primary aim of the present study is to investigate - in a randomized trial - if use of standard adjuvant chemotherapy therapy improves the disease free survival in patients with molecular biological residual disease where adjuvant chemotherapy is not standard treatment . Secondary aims include investigating molecular biological response to adjuvant chemotherapy in patients with post-operative ctDNA.