Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Disease Progression

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Capecitabine

Leucovorin

Fluorouracil

Oxaliplatin

Adjuvant chemotherapy + intensified follow-up schedule

Six months of adjuvant combination chemotherapy with Capox (or FOLFOX) Patients will receive adjuvant chemotherapy with eight cycles of CAPOX (oxaliplatin 130 mg/m2 day 1 and capecitabine 1000 mg/m2 b.i.d. days 1-14, repeated every 3 weeks.

(Patients with an ileostomy are only eligible for FOLFOX and will be treated with 12 cycles of FOLFOX (oxaliplatin 85 mg/m2 day 1, leucovorin 400 mg/m2 day 1, 5FU 400 mg/m2 bolus day 1 and 5FU 2400 mg/ m2 over 46-48 hours day 1-3, repeated every second weeks)

Capox (or FOLFOX) including flouropyrimidine and oxaliplatin combination chemotherapy

Close monitoring with Imaging during follow-up Patients included in this trial will undergo intensified follow-up with CT-chest and abdomen every four months after surgery for the first 2 years, then every 6 months for 1 years and finally once yearly for the last 2 years up to 5 years follow-up is completed.

Intensified Follow-up Schedule

Karen-Lise G Spindler, Professor

Karen-Lise G Spindler, Prof.

Line M Sparvath, CRN

Søren Lauerberg, Prof.

Claus L Andersen, Prof.

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.

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.

A open label 1:1 randomized phase II exploratory study

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

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

Molecular biological response at 6 months

Molecular biological disease free survival at 1 year

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
IMPROVE Intervention Trial Implementing Non-invasive Circulating Tumor DNA Analysis to Optimize the Operative and Postoperative Treatment for Patients With Colorectal Cancer	NCT03748680	Colorectal Canc... Circulating Tum... Adjuvant Chemot... Progression Fre...	Capox (or FOLFO... Intensified Fol...	18 Years -	Aarhus University Hospital
IMPROVE Intervention Trial Implementing Non-invasive Circulating Tumor DNA Analysis to Optimize the Operative and Postoperative Treatment for Patients With Colorectal Cancer	NCT03748680	Colorectal Canc... Circulating Tum... Adjuvant Chemot... Progression Fre...	Capox (or FOLFO... Intensified Fol...	18 Years -	Aarhus University Hospital

Spots Global Cancer Trial Database for capox (or folfox) including flouropyrimidine and oxaliplatin combination chemotherapy