OPTIMISE: A study investigating if analysis of cancer DNA in blood can be used to guide adjuvant treatment in patients with advanced colorectal cancer
- Conditions
- MedDRA version: 21.0Level: PTClassification code 10010035Term: Colorectal cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-004524-41-DK
- Lead Sponsor
- Aarhus University Hospital/Karen-Lise Garm Spindler
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 350
•Radical intended treatment for metastatic spread from CRC, by resection, RFA, SBRT (or other experimental local treatment options)
•No evidence of further disease based on pre-treatment work-up according to SOC
•Age at least 18 years
•ECOG performance status 0-2
•Clinically eligible for adjuvant triple CT at investigators decision.
•Adequate bone marrow, liver and renal function allowing systemic CT (Absolute neutrophil count =1.5x109/l and thrombocytes = 100x109/l. Bilirubin = 1.5 x upper normal value and alanine aminotransferase = 3 x upper normal value, and calculated or measured renal glomerular filtration rate at least 30 mL/min)
•Anticonception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject’s male partner or hormonal contraceptive are acceptable
•Written and verbally informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 175
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 175
•Neuropathy National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade > 1
•Other malignant tumour within 5 years except non-melanoma skin cancer or carcinoma in situ cer-vi-
cis uteri
•Pregnant (positive pregnancy test) or breast feeding women
•Intolerance or allergy to 5FU, leucovorin, oxaliplatin, irinotecan or capecitabin
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: Secondary aims include investigating molecular biological response to chemotherapy, cost effectiveness, quality of life in patients tested for circulating tumour-marker positivity. ;Primary end point(s): Rate of patients free from recurrent CRC at 2 years post local treatment;Timepoint(s) of evaluation of this end point: August 2026;Main Objective: The primary aim of the present study is thus to investigate – in a randomized trial – the clinical utility of circulating tumor DNA analysis to guide treatment decisions in oligometastatic colorectal cancer.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •Rate of grade 3-5 toxicity 6 months post-treatment <br>•Molecular biological response to therapy after 6 months <br>•Molecular biological DFS at 1 year <br>•Time to molecular biological recurrence <br>•Time to radiological recurrence <br>•Local and distant relapse <br>•Overall survival <br>•QoL (EORTC QLQ – C30 and – CR29) and questionnaires for patients preferences <br>•Cost effective analysis <br><br>Definition of endpoint <br>•Molecular biological response is defined as lack of detectable tumour DNA in plasma samples <br>•Time to molecular biological recurrence is calculated from first time of no detectable DNA until de-tectable DNA in a samples <br>•DFS is defined as the time from inclusion to the first clinical event of local relapse, distant relapse or death <br>•Overall survival is defined as the time from inclusion to death from any cause. ;Timepoint(s) of evaluation of this end point: August 2029