EUCTR2020-004524-41-DK
Active, not recruiting
Phase 1
OPTIMISE: OPTIMIzation of treatment SElection and follow up in oligometastatic colorectal cancer - a ctDNA guided phase II randomized approach - OPTIMISE
Aarhus University Hospital/Karen-Lise Garm Spindler0 sites350 target enrollmentOctober 7, 2020
ConditionsMedDRA 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]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- MedDRA version: 21.0Level: PTClassification code 10010035Term: Colorectal cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Sponsor
- Aarhus University Hospital/Karen-Lise Garm Spindler
- Enrollment
- 350
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
Exclusion Criteria
- •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\-
- •Pregnant (positive pregnancy test) or breast feeding women
- •Intolerance or allergy to 5FU, leucovorin, oxaliplatin, irinotecan or capecitabin
Outcomes
Primary Outcomes
Not specified
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