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

• Conditions: patientes resected for colon cancer and treated with moderate emetogenus; MedDRA version: 9.1Level: LLTClassification code 10009944Term: Colon cancer

• Registration Number: EUCTR2006-002935-25-IT
• Lead Sponsor: GOIM GRUPPO ONCOLOGICO MERIDIONALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-02
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

radically resected colorectal cancer patients(stage III).

adjuvant treatment with folfox-4 schedule

age: > 18 years

performance status <1

written informated consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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