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Circulating Tumor DNA Analysis to Optimize the Operative and Postoperative Treatment for Patients With Colorectal Cancer - Intervention Trial 2 (IMPROVE-IT2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04084249
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : June 22, 2022
Sponsor:
Collaborator:
University of Aarhus
Information provided by (Responsible Party):
Claus Lindbjerg Andersen, Aarhus University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Diagnostic Test: ctDNA-analysis Other: Intensified Follow-up Schedule Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Implementing Non-invasive Circulating Tumor DNA Analysis to Optimize the Operative and Postoperative Treatment for Patients With Colorectal Cancer - Intervention Trial 2
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2028
Arms and Interventions
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Arm Intervention/treatment
Experimental: ctDNA guided surveillance
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 months 4, 12, 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 FCRI questionnaire.
 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
No Intervention: Standard Danish follow-up program
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 months 4, 12, 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).


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. 3yr-OS [ Time Frame: 3 years ]
    Overall survival at 3 years

  2. 5yr-OS [ Time Frame: 5 years ]
    Overall survival at 5 years

  3. TTCR [ Time Frame: 3 years ]
    Time to clinical recurrence

  4. TTMR [ Time Frame: 2 years ]
    Time to molecular recurrence

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04084249


Contacts
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Contact: Claus L Andersen, PhD +45 78455319 cla@clin.au.dk
Contact: Kaare A Gotschalck, PhD +45 78423786 kaarsune@rm.dk

Locations
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Denmark
Surgical Department, Randers Regional Hospital Recruiting
Randers, Denmark, 8930
Contact: Kaare Andersson Gotschalck, MD, PhD       kaarsune@rm.dk   
Contact: Jesper Nors, MD    c ext +45    jenors@rm.dk   
Sponsors and Collaborators
Claus Lindbjerg Andersen
University of Aarhus
Investigators
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Principal Investigator: Claus L Andersen, PhD Department of Molecular Medicin, Aarhus University Hospital
More Information
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Responsible Party: Claus Lindbjerg Andersen, Prof., Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT04084249    
Other Study ID Numbers: IMPROVE-IT2
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: June 22, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Colorectal Neoplasms
Rectal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Colonic Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Colonic Diseases
Rectal Diseases
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site