OPTIMISE
- Conditions
- Colorectal cancer with metastasisTherapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-509814-12-00
- Lead Sponsor
- Region Midtjylland
- 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 colorectal cancer, by resection, RFA, SBRT (or other experimental local treatment options) not including cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC), No evidence of further disease based on pre-treatment work-up according to standard of care, 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 chemotherapy (absolute neutrophil count =1.5x10^9/l and thrombocytes = 100x10^9/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
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 cervicis 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 Main Objective: The primary aim of the present study is to investigate - in a randomized trial - the clinical utility of circulating tumor DNA analysis to guide treatment decisions in oligometastatic colorectal cancer;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 colorectal cancer at 2 years after inclusion
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Rate of CTCAE grade 3-5 toxicity 6 months post-treatment;Secondary end point(s):Molecular biological response to therapy after 6 months;Secondary end point(s):Molecular biological disease-free survival at 1 year;Secondary end point(s):Time to molecular biological recurrence;Secondary end point(s):Time to radiological recurrence;Secondary end point(s):Local and distant relapse;Secondary end point(s):Overall survival;Secondary end point(s):QoL (EQ-5D-5L, EORTC QLQ–C30 and –CR29, explorative ctDNA utility questionnaire);Secondary end point(s):Cost-effective analysis