Colonic Cancer, Colonic Diseases, Colonic Neoplasms, Colo-rectal Cancer, Colorectal Cancer, Colorectal Neoplasms, ctDNA, Digestive System Disease, Digestive System Neoplasm, Gastrointestinal Cancer, Gastro-Intestinal Disorder, Gastrointestinal Neoplasms, Rectal Cancer, Rectal Diseases, Rectal Neoplasms
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTctDNA-analysis
Minimally-invasive blood-based analysis of circulating tumor DNA (ctDNA).
PET/CT-scans every 3. month
Sponsors
Claus Lindbjerg Andersen
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FCI | 5 years | Fraction of patients with relapse receiving intended curative resection or local treatment aiming at complete tumor destruction as defined at the relevant MDT conference. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TTCR | 3 years | Time to clinical recurrence |
| 3yr-OS | 3 years | Overall survival at 3 years |
| 5yr-OS | 5 years | Overall survival at 5 years |
| QoL | 3 years | Quality of Life by use of EORTC QLQ-C30, version 3.0. The QoL outcome measure is differences in QLQ-C30 score at 12, 24 and 36 months between the experimental and control arm. |
| CE | 5 years | Cost-effectiveness. QoL/Utility weights for the quality-adjusted life years parameter will be QLU-C10D based on EORTC QLQ-C30. |
| AR | 3 years | Adherence rate for patients following ctDNA-guided and standard of care surveillance |
| TTMR | 2 years | Time to molecular recurrence |
| FCRI | 3 years | Fear of Cancer Recurrence Inventory. The FCRI outcome measure is differences in FCRI at 12, 24 and 36 months between the experimental and control arm. |
| IES-C | 3 years | Impact of Events Scale Cancer. The IES-C outcome measure is differences in IES-C at 12, 24 and 36 months between the experimental and control arm. |
Countries
Denmark
Contacts
PRINCIPAL_INVESTIGATORClaus L Andersen, PhD
Department of Molecular Medicin, Aarhus University Hospital
Outcome results
None listed