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

Claus Lindbjerg Andersen

Status: Active, not recruiting

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

Treatments: Diagnostic Test: ctDNA-analysis; Other: Intensified Follow-up Schedule

Study type: Interventional

Funder types: Other

Identifiers

NCT04084249

IMPROVE-IT2

Details and patient eligibility

About

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.

Enrollment: 359 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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359 participants in 2 patient groups

ctDNA guided surveillance

Experimental group

Description:

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 baseline and months 12, 18, 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 questionnaire.

Treatment:

Other: Intensified Follow-up Schedule

Diagnostic Test: ctDNA-analysis

Standard Danish follow-up program

No Intervention group

Description:

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 baseline and months 12, 18, 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).