Active — Not RecruitingNot Applicable

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

Denmark359 participantsStarted 2020-01-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

FCI

Timeframe: 5 years

Trial details

NCT IDNCT04084249

SponsorClaus Lindbjerg Andersen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06-30

View on ClinicalTrials.gov More Colorectal Cancer trials