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)

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) - CAIRO5

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54605

Enrollment

584

Registered

2014-02-04

Start date

2014-10-31

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Cancer Colorectal cancer

Interventions

*Schedule 1: 5-fluorouracil, oxaliplatin (FOLFOX) or 5-fluorouracil, irinotecan (FOLFIRI), both combined with bevacizumab *Schedule 2: 5-fluorouracil, oxaliplatin, irinotecan (FOLFOXIRI) and bevacizu

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Histologically proven colorectal cancer , - unresectable metastases confined to the liver according to CT scan, obtained = 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

Exclusion criteria

Exclusion criteria: - Extrahepatic metastases, with the exception of small (=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

Design outcomes

Primary

Measure	Time frame
Progression free survival (PFS).	—

Secondary

Measure	Time frame
- R0/1 resection rate - Median overall survival - 3- and 5-year overall survival rates - Tumor response rate - Toxicity - Pathological complete response rate (pCR) of resected lesions - Postoperative morbidity.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)