bowel cancer colorectal cancer rectum cancer
Conditions
Interventions
resection of the primary tumour
Sponsors
Dutch Colorectal Cancer Group
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Histological proof of colorectal cancer Resectable primary tumour in situ with unresectable distant metastases No indication for neo-adjuvant (chemo)radiation. No severe signs or symptoms related to the primary tumour (i.e. severe bleeding, obstruction, severe abdominal pain) that require immediate surgery or other symptomatic treatment (e.g. stenting) (see 6.4 for exceptions) No prior systemic treatment for advanced disease Age >= 18 years WHO performance status 0-2 Laboratory values obtained
Exclusion criteria
Exclusion criteria: Pregnancy, lactation Unresectable primary tumour (i.e. neurovascular encasement, substantial ingrowth in pancreatic head), or any condition preventing the safety or feasibility of resection of the primary tumour, i.e. massive ascites or extensive peritoneal disease Second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin Any medical condition that prevents the safe administration of systemic treatment Previous intolerance of fluoropyrimidines, known complete dihydropyrimidine dehydrogenase (DPD) deficiency (Planned) radical resection of all metastatic disease Uncontrolled hypertension, i.e. values consistently > 150/100 mmHg Use of * 3 antihypertensive drugs Significant cardiovascular disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is overall survival in the intent-to-treat population. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are progression-free survival, response to chemotherapy of the primary tumour compared to the response of metastases, systemic therapy related toxicity, surgery related morbidity and mortality (30 and 90 days), quality of life (QoL), interval between randomization and initiation of systemic treatment, cost-benefit analysis, patients requiring resection of the primary tumour in the non-resection arm, and overall survival in patients in whom treatment according to protocol was initiated (i.e. having received at least one cycle of systemic treatment in arm A, and surgery in arm B). Patients without recurrence and alive at the time of the analysis will be included as censored data. PFS curves will be constructed by means of the Kaplan Meier method. Comparisons of PFS curves will performed by mean of the Logrank test. Similar methods will be used to analyse the duration of survival. Analyses will be done in eligible patients according to the intention-to-treat principle. | — |
Countries
Netherlands
Outcome results
None listed