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Evaluation of initially unresectable metastatic colorectal cancer patients treated with 5-fluorouracil/leucovorin, oxaliplatin and irinotecan (FOLFOXIRI) followed by radical surgery of metastases.

Evaluation of overall survival of initially unresectable metastatic colorectal cancer patients treated with 5-fluorouracil/leucovorin, oxaliplatin and irinotecan (FOLFOXIRI) followed by radical surgery of metastases

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12608000615381
Enrollment
37
Registered
2008-12-08
Start date
1999-05-01
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

The primary purpose of the study is to verify if patients with metastatic colorectal cancer, who have been treated with first-line triple drug combination FOLFOXIRI and who have underwnt to radical surgical resection of metastases, may reach a prolonged overall survival and so a chance of cure for their metastatic diseases

Interventions

Observation: metastatic colorectal cancer patients who have been treated in first-line with FOLFOXIRI (a triple drug combination of irinotecan 165 mg/square meter ("sqm") endovenous ("ev") in 1 hour, oxaliplatin 85 mg/sqm ev in 2 hours and 5-fluorouracil 3200 mg/sqm as a 48-hour continous infusion ev plus leucovorin 200 mg/sqm ev in 2 hours, every 14 days for 12 cycles) and who underwent radical surgical resection of metastases will be followed up yearly for 5 years after the diagnosis of diseas

Observation: metastatic colorectal cancer patients who have been treated in first-line with FOLFOXIRI (a triple drug combination of irinotecan 165 mg/square meter ("sqm") endovenous ("ev") in 1 hour, oxaliplatin 85 mg/sqm ev in 2 hours and 5-fluorouracil 3200 mg/sqm as a 48-hour continous infusion ev plus leucovorin 200 mg/sqm ev in 2 hours, every 14 days for 12 cycles) and who underwent radical surgical resection of metastases will be followed up yearly for 5 years after the diagnosis of disease to collect their survival status.

Sponsors

Gruppo Oncologico del Nord-Ovest "GONO"
Lead SponsorOther Collaborative groups

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Metastatic colorectal cancer; Unresectable disease at diagnosis; First-line treatment with FOLFOXIRI

Exclusion criteria

Treatment with chemotherapy different from FOLFOXIRI; Eastern Cooperative Oncology Group (ECOG) Performance status (PS) >2

Outcome results

None listed

Source: ANZCTR · Data processed: Apr 3, 2026