MedDRA version: 21.0 Level: PT Classification code 10010035 Term: Colorectal cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Irinotecan
Pharmaceutical Form: Infusion
INN or Proposed INN: IRINOTECAN
CAS Number: 97682-44-5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration nu
Sponsors
Aarhus University Hospital/Karen-Lise Garm Spindler
Eligibility
Sex/Gender
All
Inclusion 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: 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
Exclusion criteria
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- cis uteri • Pregnant (positive pregnancy test) or breast feeding women • Intolerance or allergy to 5FU, leucovorin, oxaliplatin, irinotecan or capecitabin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Rate of grade 3-5 toxicity 6 months post-treatment • Molecular biological response to therapy after 6 months • Molecular biological DFS at 1 year • Time to molecular biological recurrence • Time to radiological recurrence • Local and distant relapse • Overall survival • QoL (EORTC QLQ – C30 and – CR29) and questionnaires for patients preferences • Cost effective analysis Definition of endpoint • Molecular biological response is defined as lack of detectable tumour DNA in plasma samples • Time to molecular biological recurrence is calculated from first time of no detectable DNA until de-tectable DNA in a samples • DFS is defined as the time from inclusion to the first clinical event of local relapse, distant relapse or death • Overall survival is defined as the time from inclusion to death from any cause. ;Timepoint(s) of evaluation of this end point: August 2029 | — |
Countries
Denmark
Contacts
Public ContactExperimental Clinical Oncology, AUH
Karen-Lise Garm Spindler
Outcome results
None listed