Implementing Non-invasive Circulating Tumor DNA Analysis to Optimize the Operative and Postoperative Treatment for Patients With Colorectal Cancer - Intervention Trial 2
| Registry | NCT04084249 |
|---|---|
| Status | Active not recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, diagnostic |
| Enrollment | 359 (Actual) |
| Sponsor | Claus Lindbjerg Andersen (Other); collaborators: University of Aarhus |
| Conditions | Colorectal Cancer, Colo-rectal Cancer, ctDNA, Gastro-Intestinal Disorder, Colorectal Neoplasms, Gastrointestinal Cancer, Gastrointestinal Neoplasms, Digestive System Disease, Digestive System Neoplasm, Colonic Diseases, Colonic Neoplasms, Colonic Cancer, Rectal Diseases, Rectal Neoplasms, Rectal Cancer |
| Interventions | ctDNA-analysis, Intensified Follow-up Schedule (Diagnostic test, other) |
| Dates | start 2020-01-01, primary completion 2028-06-30 (estimated), completion 2028-06-30 (estimated), first posted 2019-09-10, last updated 2026-04-29 |
| Locations | 10 sites in Denmark |
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IMPROVE-IT2 is a randomized multicenter trial comparing the outcomes of ctDNA guided post-operative surveillance and standard-of-care CT-scan surveillance. The hypothesis of this study is that ctDNA guided post-operative surveillance combining ctDNA and radiological assessments could result in earlier detection of recurrent disease and identify more patients eligible for curative treatment.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| ctDNA guided surveillance | Experimental | Diagnostic Test: ctDNA-analysis; Other: Intensified Follow-up Schedule | 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. |
| Standard Danish follow-up program | No intervention | 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). |
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Herlev Hospital | Herlev, Capital Region of Denmark | Denmark | |
| Gødstrup Hospital | Herning, Central Jutland | Denmark | |
| Regional Hospital Horsens | Horsens, Central Jutland | Denmark | |
| Regional Hospital Randers | Randers, Central Jutland | Denmark | |
| Aalborg University Hospital | Aalborg, North Denmark | Denmark | |
| Odense University Hospital | Odense, The Region of Southern Denmark | Denmark | |
| Aarhus University Hospital | Aarhus | Denmark | |
| Bispebjerg Hospital | Copenhagen | Denmark | |
| Zealand University Hospital | Køge | Denmark | |
| Regional Hospital Viborg | Viborg | Denmark |