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

• Status: Recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karen-Lise Garm Spindler
• Treatments: Oxaliplatin

Criteria

Inclusion Criteria:

• Surgically removed Adenocarcinoma of the colon or rectum

• Pathologically stage I or II disease, and radical resection

• Detectable ctDNA in two weeks postoperative plasma sample

• No indication for adjuvant chemotherapy according to DCCG guidelines (website)

• Age at least 18 years

• ECOG performance status 0-2

• Clinically eligible for adjuvant chemotherapy at investigators decision.

• Adequate bone marrow, liver and renal function allowing systemic chemotherapy (Absolute neutrophil count ≥1.5x109/l and thrombocytes ≥ 100x109/l. Bilirubin ≤ 1.5 x upper normal value and alanine aminotransferase ≤ 3 x upper normal value, and Calculated or measured renal glomerular filtration rate at least 30 mL/min)

• Anticonception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable •

• Written and verbally informed consent

Exclusion Criteria:

• Radiological evidence of distant metastasis, by CT- chest and abdomen

• Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with combination chemotherapy

• Previous treatment with 5FU or oxaliplatin

• Neuropathy NCI grade > 1

• Other malignant tumor within 5 years except non-melanoma skin cancer or carcinoma in situ cervicis uteri

• Pregnant (positive pregnancy test) or breast feeding women