Treatment strategies in colorectal cancer patients with initially unresectable liver-only metastases. CAIRO5 a randomized phase 3 study of the Dutch Colorectal Cancer Group (DCCG)

Phase 3

Recruiting

• Conditions: Bowel Cancer; 10017991; Colorectal cancer

• Registration Number: NL-OMON54605
• Lead Sponsor: Dutch Colorectal Cancer Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 584

Inclusion Criteria

- Histologically proven colorectal cancer , - unresectable metastases confined
to the liver according to CT scan, obtained <= 2 weeks prior to registration.
Unresectability will be confirmed by the panel. Patients with small (<= 1 cm)
extrahepatic lesions that are not clearly suspicious of metastases are
eligible., - RAS/BRAF mutation status known, - WHO performance status 0-1
(Karnofsky performance status >= 70), - Age >= 18 years, - No contraindications
for liver surgery, - In case of primary tumor in situ: tumor should be
resectable
- In case of resected primary tumor: adequate recovery from surgery, - 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 or more, - Expected
adequacy of follow-up, - Written informed consent

Exclusion Criteria

- Extrahepatic metastases, with the exception of small (<= 1 cm) extrahepatic
lesions that are not clearly suspicious for metastases , - Unresectable 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 before registration, - 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 registration, - Previous surgery
for metastatic disease, - Previous intolerance of study drugs in the adjuvant
setting, - Pregnant or lactating women, - 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Progression free survival (PFS). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- R0/1 resection rate<br /><br>- Median overall survival<br /><br>- 3- and 5-year overall survival rates<br /><br>- Tumor response rate<br /><br>- Toxicity<br /><br>- Pathological complete response rate (pCR) of resected lesions<br /><br>- Postoperative morbidity. </p><br>