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

N/AActive Not RecruitingNCT04084249

Claus Lindbjerg Andersen359 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

359

Conditions

Colorectal Cancer Colo-rectal Cancer ctDNA Gastro-Intestinal Disorder Colorectal Neoplasms Gastrointestinal Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (10)

Herlev Hospital

Herlev, Capital Region of Denmark, Denmark

Gødstrup Hospital

Herning, Central Jutland, Denmark

Regional Hospital Horsens

Horsens, Central Jutland, Denmark

Regional Hospital Randers

Randers, Central Jutland, Denmark

Aalborg University Hospital

Aalborg, North Denmark, Denmark

Odense University Hospital

Odense, The Region of Southern Denmark, Denmark

Aarhus University Hospital

Aarhus, Denmark

Bispebjerg Hospital

Copenhagen, Denmark

Zealand University Hospital

Køge, Denmark

Regional Hospital Viborg

Viborg, Denmark

Outcomes

Primary Outcomes

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.

Time frame: 5 years

Secondary Outcomes

TTCR

Time to clinical recurrence

Time frame: 3 years

3yr-OS

Overall survival at 3 years

Time frame: 3 years

5yr-OS

Overall survival at 5 years

Time frame: 5 years

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.

Time frame: 3 years

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

Time frame: 5 years

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

Time frame: 3 years

TTMR

Time to molecular recurrence

Time frame: 2 years

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.

Time frame: 3 years

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.

Time frame: 3 years

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

Overview

Conditions

Interventions

Eligibility

Locations (10)

Outcomes

Primary Outcomes

Secondary Outcomes