Clinical trial NCT04084249: ctDNA-guided Surveillance for Stage III CRC, a Randomized Intervention 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: University of Aarhus
First posted: 2019-09-10
Enrollment: 359
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility 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.

Primary outcomes:
measure: FCI
timeFrame: 5 years
Secondary outcomes:
measure: TTCR
timeFrame: 3 years
measure: 3yr-OS
timeFrame: 3 years
measure: 5yr-OS
timeFrame: 5 years
measure: QoL
timeFrame: 3 years
measure: CE
timeFrame: 5 years
measure: AR
timeFrame: 3 years
measure: TTMR
timeFrame: 2 years
measure: FCRI
timeFrame: 3 years
measure: IES-C
timeFrame: 3 years
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
state: Capital Region Of Denmark
city: Herning
country: Denmark
facility: Gødstrup Hospital
state: Central Denmark Region
city: Horsens
country: Denmark
facility: Regional Hospital Horsens
state: Central Denmark Region
city: Randers
country: Denmark
facility: Regional Hospital Randers
state: Central Denmark Region
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
state: North Denmark Region
city: Odense
country: Denmark
facility: Odense University Hospital
state: The Region Of Southern Denmark
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Køge
country: Denmark
facility: Zealand University Hospital
city: Viborg
country: Denmark
facility: Regional Hospital Viborg
Study officials:
affiliation: Department of Molecular Medicin, Aarhus University Hospital
name: Claus L Andersen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.