Colorectal Cancer Clinical Trial
Official title:
Implementing Non-invasive Circulating Tumor DNA Analysis to Optimize the Operative and Postoperative Treatment for Patients With Colorectal Cancer - Intervention Trial 2
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.
Status | Recruiting |
Enrollment | 340 |
Est. completion date | June 30, 2028 |
Est. primary completion date | June 30, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Surgical Department, Randers Regional Hospital | Randers |
Lead Sponsor | Collaborator |
---|---|
Claus Lindbjerg Andersen | University of Aarhus |
Denmark,
Nors J, Henriksen TV, Gotschalck KA, Juul T, Sogaard J, Iversen LH, Andersen CL. IMPROVE-IT2: implementing noninvasive circulating tumor DNA analysis to optimize the operative and postoperative treatment for patients with colorectal cancer - intervention trial 2. Study protocol. Acta Oncol. 2020 Mar;59(3):336-341. doi: 10.1080/0284186X.2019.1711170. Epub 2020 Jan 10. No abstract available. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | FCI | Fraction of patients with relapse receiving intended curative resection or local treatment aiming at complete tumor destruction as defined at the relevant MDT conference. | 5 years | |
Secondary | 3yr-OS | Overall survival at 3 years | 3 years | |
Secondary | 5yr-OS | Overall survival at 5 years | 5 years | |
Secondary | TTCR | Time to clinical recurrence | 3 years | |
Secondary | TTMR | Time to molecular recurrence | 2 years | |
Secondary | QoL | 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. | 3 years | |
Secondary | FCRI | 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. | 3 years | |
Secondary | IES-C | 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. | 3 years | |
Secondary | CE | Cost-effectiveness. QoL/Utility weights for the quality-adjusted life years parameter will be QLU-C10D based on EORTC QLQ-C30. | 5 years |
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