The role of surgery of the primary tumour with few or -absent symptoms in patients with synchronous unresectable metastases of colorectal cancer, a randomized phase III study

Phase 3

Completed

• Conditions: bowel cancer; colorectal cancer; rectum cancer; 10017990

• Registration Number: NL-OMON50614
• Lead Sponsor: Dutch Colorectal Cancer Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2024-03-29
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 176

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 <= 4 weeks prior to randomization: Adequate bone
marrow function (Hb * 6.0 mmol/L, absolute neutrophil count * 1.5 x 109/L,
platelets * 100 x 109/L), renal function (serum creatinine <= 1.5x ULN and
creatinine clearance, Cockroft formula, * 30 ml/min), liver function (serum
bilirubin <= 2 x ULN, serum transaminases <= 3 x ULN without presence of liver
metastases or <= 5x ULN with presence of liver metastases)
Expected adequacy of follow-up
Written informed consent
Unidimensionally measurable disease (* 1 cm on CT scan or * 2 cm on chest
X-ray; liver ultrasound is not allowed, according to RECIST 1.1)
CT abdomen performed <= 4 weeks prior to randomization

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 < 1 yr before randomization (symptomatic
congestive heart failure, myocardial infarction, unstable angina pectoris,
serious uncontrolled cardiac arrhythmia, cerebrovascular event)
Chronic active infection
Concurrent treatment with any other anti-cancer therapy as described per
protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of the study is overall survival in the intent-to-treat<br /><br>population.</p><br>