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multicenter phase II study to evaluate palonosetron +desametasone in the prevention of nausea and vomiting in patientes resected for colon cancer and treated with moderate emetogenus chemotherapy. - paol.+desam. in the prevention of nausea and vomiting

multicenter phase II study to evaluate palonosetron +desametasone in the prevention of nausea and vomiting in patientes resected for colon cancer and treated with moderate emetogenus chemotherapy. - paol.+desam. in the prevention of nausea and vomiting

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-002935-25-IT
Enrollment
Unknown
Registered
2007-07-02
Start date
2006-06-27
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

patientes resected for colon cancer and treated with moderate emetogenus MedDRA version: 9.1 Level: LLT Classification code 10009944 Term: Colon cancer

Interventions

Trade Name: LEDERFOLIN*EV 1FL LIOF 175MG Pharmaceutical Form: Solution for infusion INN or Proposed INN: Calcium levofolinate CAS Number: 80433-71-2 Concentration unit: mg milligram(s) Concentration t

Sponsors

GOIM GRUPPO ONCOLOGICO MERIDIONALE
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: radically resected colorectal cancer patients(stage III). adjuvant treatment with folfox-4 schedule age: > 18 years performance status =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: chemotherapy with schedule different from folfox-4 previous antiemetic treatments previous treatment with palonosetron lacting or pregnat women planned treatment with radiotherapy with 30 days before the strat of the stady clinical evidence of bowel obstruction, serious infections, serious mucosites.

Design outcomes

Primary

MeasureTime frame
Main Objective: to evaluate the efficacy of palonosetron + desametasone in the prevention of nausea and vomiting in patients treated with moderate emetogenous chemotherapy;Secondary Objective: to eveluate the safety of palonosetron;Primary end point(s): to evaluate the efficacy of palonosetron + desametasone in the prevention of nausea and vomiting in patients treated with moderate emetogenous chemotherapy—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026