Perioperative systemic therapy and cytoreductive surgery with HIPEC versus upfront cytoreductive surgery with HIPEC alone: a multicentre, open-label, parallel-group, phase II-III, randomised superiority study (CAIRO6).

Perioperative systemic therapy and cytoreductive surgery with HIPEC versus upfront cytoreductive surgery with HIPEC alone: a multicentre, open-label, parallel-group, phase II-III, randomised superiority study (CAIRO6). - CAIRO6

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55637

Enrollment

298

Registered

2016-09-14

Start date

2017-06-15

Completion date

Unknown

Last updated

2025-09-01

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

Conditions

Peritoneal metastases of colorectal cancer

Interventions

At the discretion of the treating medical oncologist, perioperative systemic therapy consists of either four 3-weekly neoadjuvant and adjuvant cycles of capecitabine with oxaliplatin (CAPOX), six 2-

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Eligible patients are adults who have: * a World Health Organisation (WHO) performance status of

Exclusion criteria

Exclusion criteria: Patients are excluded in case of any comorbidity or condition that prevents safe administration of the planned perioperative systemic therapy, determined by the treating medical oncologist, e.g.: * Inadequate bone marrow, renal, or liver functions (e.g. haemoglobin 1.5 x ULN, creatinine clearance 2 x ULN, serum liver transaminases >5 x ULN); * Previous intolerance of fluoropyrimidines or both oxaliplatin and irinotecan; * Dehydropyrimidine dehydrogenase deficiency; * Serious active infections; * Severe diarrhoea; * Stomatitis or ulceration in the mouth or gastrointestinal tract; * Recent major cardiovascular events; * Unstable or uncompensated respiratory or cardiac disease; * Bleeding diathesis or coagulopathy; * Pregnancy or lactation.

Design outcomes

Primary

Measure	Time frame
Endpoints of the phase II study are to explore the feasibility of accrual, the feasibility, safety, and tolerance of perioperative systemic therapy, and the radiological/histological response of colorectal PM to neoadjuvant systemic therapy. The primary endpoint of the phase III study is 3-year overall survival, which is hypothesised to be 50% in the control arm and 65% in the experimental arm, thereby requiring 358 patients (179 in each arm).	—

Measure

Time frame

Endpoints of the phase II study are to explore the feasibility of accrual, the feasibility, safety, and tolerance of perioperative systemic therapy, and the radiological/histological response of colorectal PM to neoadjuvant systemic therapy. The primary endpoint of the phase III study is 3-year overall survival, which is hypothesised to be 50% in the control arm and 65% in the experimental arm, thereby requiring 358 patients (179 in each arm).

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Secondary

Measure	Time frame
Secondary endpoints are surgical characteristics, grade >=3 postoperative morbidity, progression-free survival, disease-free survival, health-related quality of life, costs, major systemic therapy related toxicity, and objective radiological and histological response rates of colorectal PM to neoadjuvant systemic therapy.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)