Phase III Multicenter Randomized Trial Comparing Adjuvant Pharmacogenomic-Driven Chemotherapy versus Standard Adjuvant Chemotherapy in Completely Resected Stage II-IIIA Non-Small Cell Lung Cancer. - International TAilored Chemotherapy Adjuvant

• Conditions: patients with completely resected Stage II-IIIA non-small cell lung cancer; MedDRA version: 9.1Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disorders

• Registration Number: EUCTR2008-001764-36-IT
• Lead Sponsor: Azienda Ospedaliero Universitaria ''San Luigi Gonzaga''

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

All patients must have histological evidence of pathological stage II-IIIA non-small cell lung cancer after radical surgery. All surgical margins of resection must be negative for tumor (R0). Patients must be ≥ 18 years of age and provide written voluntary informed consent. Patients must have an ECOG PS of 0 ? 1, not have received any systemic chemotherapy or radiation therapy prior to resection of lung cancer and an interval of 45 to 60 days must have been elapsed between surgery and the start of adjuvant therapy.
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

Patients must not have any prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient has been disease-free for at least 5 years prior to enrollment, peripheral neuropathy ³ common toxicity criteria Grade 1. In addition, patients must not have had recent (within 30 days of study treatment) or concurrent yellow fever vaccination, a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV. Patients must be able to interrupt concurrent treatment with aspirin or other non-steroidal anti-inflammatory agents, other than an aspirin dose ≤ 1.3 grams per day, for a 5-day period (8-day period for longacting agents, such as piroxicam) and must be willing and able to take folic acid, vitamin B12 supplementation or corticosteroids. Patients must have no history of severe hypersensitivity reactions to products containing cremophor.

Study & Design

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