Circulating Tumor DNA Analysis to Optimize the Operative and Postoperative Treatment for Patients With Colorectal Cancer - Intervention Trial 2 (IMPROVE-IT2)
Colorectal Cancer, Colo-rectal Cancer, ctDNA
About this trial
This is an interventional diagnostic trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Colon or rectal cancer, tumor stage III (pT1-4N1-2,cM0) or stage II high-risk (pT4N0,cM0 and pT3N0, cM0 with risk factors)
- Have received curative intend resection and be candidates for adjuvant chemotherapy
Exclusion Criteria:
- Not treated with adjuvant chemotherapy
- Synchronous colorectal and non-colorectal cancer diagnosed per-operative (except skin cancer other than melanoma)
- Other cancers (excluding colorectal cancer or skin cancer other than melanoma) within 3 years from screening
- Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study.
Sites / Locations
- Surgical Department, Randers Regional HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
ctDNA guided surveillance
Standard Danish follow-up program
ctDNA analysis will be performed every 4 months postoperatively (4, 8, 12, 16, 20 and 24). At time of first positive ctDNA, patients undergo a whole-body FDG-PET/CT-scan for radiological assessment and a colonoscopy. If the initial assessment is without evidence of recurrence, patients will be offered high-intensive radiological surveillance with FDG-PET/CT-scans every 3 months, until recurrence detection or 21 months has passed. At baseline and months 12, 18, 24 and 36 patients complete the QoL questionnaires including EORTC QLQ-C30, fear of cancer recurrence inventory (FCRI), and impact of events scale for cancer (IES-C). At every FDG-PET/CT-scans the patients also complete the questionnaire.
Patients will undergo surveillance according to current Danish Guidelines with CT-scans at months 12 and 36 postoperative and colonoscopy every 5 year until age 75. Longitudinal blood samples will be collected at same time-points as in the experimental group but not analyzed until end of trial. At baseline and months 12, 18, 24 and 36 patients complete the QoL questionnaires including EORTC QLQ-C30, fear of cancer recurrence inventory (FCRI), and impact of events scale for cancer (IES-C).