A randomized phase 3 study of treatment strategies for patients with colon cancer with metastases only in the liver, which is (at this moment) not eligible for surgical treatment. A study of the Dutch Colorectal Cancer Group (DCCG).

Phase 1

• Conditions: Colorectal cancer with initially irresectable liver-only metastases; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-005435-24-NL
• Lead Sponsor: Dutch Colorectal Cancer Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-04
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 584

Inclusion Criteria

-Histologically proven colorectal cancer
-Irresectable metastases confined to the liver according to CT scan, obtained = 4 weeks prior to randomization. Irresectability should be confirmed by the panel. Patients with small (= 1 cm) extrahepatic lesions that are not clearly suspicious of metastases are eligible.
-Adequate tumor tissue available for central assessment of RAS/BRAF mutation status
-WHO performance status 0-2 (Karnofsky performance = 70)
-Age = 18 years
-No contraindications for liver surgery
-in case of synchronous metastatses: resectable primary tumor, or adequate clinical recovery in case of immediate surgery of primary tumor
-Adequate organ functions, as determined by normal bone marrow function (Hb ³ 6.0 mmol/L, absolute neutrophil count ³ 1.5 x 109/L, platelets ³ 100 x 109/L), renal function (serum creatinine = 1.5x ULN and creatinine clearance, Cockroft formula, ³ 30 ml/min), liver function (serum bilirubin = 2 x ULN, serum transaminases = 5x ULN)
-Life expectancy > 12 weeks
-Expected adequacy of follow-up
-Written 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 292
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 292

Exclusion Criteria

-Extrahepatic metastases, with the exception of small (= 1 cm) extrahepatic lesions that are not clearly suspicious of metastases
-Irresectable primary tumor, or resectable tumor requiring immediate surgery
-Serious comorbidity or any other condition preventing the safe administration of study treatment (including both systemic treatment and surgery)
-Major cardiovascular events (myocardial infarction, severe/unstable angina, congestive heart failure, CVA) within 12 months of randomization
-Uncontrolled hypertension, or unsatisfactory blood pressure control with =3 antihypertensive drugs
-Previous systemic treatment for metastatic disease; previous adjuvant treatment is allowed if completed = 6 months prior to randomization
-Previous intolerance of study drugs in the adjuvant setting
-Pregnant or lactating women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified