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Active, Not Recruiting

NCT Number: NCT04084249

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Colorectal Cancer Colo-rectal Cancer Colonic Cancer Colonic Diseases Colonic Neoplasms 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 Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Cancer Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herlev Hospital, Herlev, Capital Region of Denmark, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ctDNA-analysis

Diagnostic Test

Minimally-invasive blood-based analysis of circulating tumor DNA (ctDNA).

Intensified Follow-up Schedule

Other

PET/CT-scans every 3. month

Primary outcomes

  1. FCI

    Time frame: 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 outcomes

  1. TTCR

    Time frame: 3 years

    Time to clinical recurrence

  2. 3yr-OS

    Time frame: 3 years

    Overall survival at 3 years

  3. 5yr-OS

    Time frame: 5 years

    Overall survival at 5 years

  4. QoL

    Time frame: 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.

  5. CE

    Time frame: 5 years

    Cost-effectiveness. QoL/Utility weights for the quality-adjusted life years parameter will be QLU-C10D based on EORTC QLQ-C30.

  6. AR

    Time frame: 3 years

    Adherence rate for patients following ctDNA-guided and standard of care surveillance

  7. TTMR

    Time frame: 2 years

    Time to molecular recurrence

  8. FCRI

    Time frame: 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.

  9. IES-C

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Claus Lindbjerg Andersen

Other

Collaborators

  • University of Aarhus

Registry information

Official study title

Implementing Non-invasive Circulating Tumor DNA Analysis to Optimize the Operative and Postoperative Treatment for Patients With Colorectal Cancer - Intervention Trial 2

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Sep 10, 2019
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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