IMPROVE-IT2: ctDNA-guided Surveillance for Stage III CRC, a Randomized Intervention Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04084249
• Other study ID #: IMPROVE-IT2
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: June 30, 2028

Study information

• Verified date: December 2023
• Source: University of Aarhus
• Contact: Claus L Andersen, PhD
• Phone: +45 78455319
• Email: cla[@]clin.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Colo-rectal Cancer
• Colonic Cancer
• Colonic Diseases
• Colonic Neoplasms
• Colorectal Cancer
• Colorectal Neoplasms
• ctDNA
• Digestive System Disease
• Digestive System Diseases
• Digestive System Neoplasm
• Digestive System Neoplasms
• Gastro-Intestinal Disorder
• Gastrointestinal Cancer
• Gastrointestinal Diseases
• Gastrointestinal Neoplasms
• Intestinal Diseases
• Neoplasms
• Rectal Cancer
• Rectal Diseases
• Rectal Neoplasms

Intervention

Diagnostic Test:
• ctDNA-analysis
Minimally-invasive blood-based analysis of circulating tumor DNA (ctDNA).

Other:
• Intensified Follow-up Schedule
PET/CT-scans every 3. month

Locations

Country	Name	City	State
Denmark	Surgical Department, Randers Regional Hospital	Randers

Sponsors (2)

Lead Sponsor	Collaborator
Claus Lindbjerg Andersen	University of Aarhus

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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

Outcome

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