Colorectal cancer patients MedDRA version: 21.0 Level: LLT Classification code 10010029 Term: Colorectal cancer NOS System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Capacitabine
Pharmaceutical Form:
Other descriptive name: CAPECITABINE
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 150-500
Trade Name: Oxaliplatin
Sponsors
Aarhus University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria • Surgically removed Adenocarcinoma of the colon or rectum • Pathologically stage I or II disease, and radical resection • Detectable ctDNA in two weeks postoperative plasma sample • No indication for adjuvant chemotherapy according to DCCG guidelines (website) • Age at least 18 years • ECOG performance status 0-2 • Clinically eligible for adjuvant chemotherapy at investigators decision. • Adequate bone marrow, liver and renal function allowing systemic chemotherapy (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 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: Exclusion criteria • Radiological evidence of distant metastasis, by CT- chest and abdomen • Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with combination chemotherapy • Previous treatment with 5FU or oxaliplatin • Neuropathy NCI grade > 1 • Other malignant tumor within 5 years except non-melanoma skin cancer or carcinoma in situ cervicis uteri • Pregnant (positive pregnancy test) or breast feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main clinical hypothesis is that patients having undergone radical resection from CRC do not present with detectable tumor DNA in the plasma, whereas patients with detectable tumor DNA two weeks’ post-surgery have residual microscopic disease, and consequently a high risk of diseases recurrence which can be prevented with adjuvant chemotherapy. The primary aim of the present study is to investigate – in a randomized trial - if use of standard adjuvant chemotherapy therapy improves the disease free survival in patients with molecular biological residual disease where adjuvant chemotherapy is not standard treatment ;Secondary Objective: Secondary aims include investigating molecular biological response to adjuvant chemotherapy in patients with post-operative ctDNA. ;Primary end point(s): •Disease free survival at 3 year ;Timepoint(s) of evaluation of this end point: 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Molecular biological response to therapy after 6 months. • Molecular biological disease free survival at 1 year • Time to molecular biological recurrence • Time to radiological recurrence • Local and distant relapse • Overall survival • Translational research ;Timepoint(s) of evaluation of this end point: 6 months, 1 year and 3 years | — |
Countries
Denmark
Contacts
Public ContactClinical trial Unit, Dept Oncol.
Aarhus University Hospital
Outcome results
None listed