patients with completely resected Stage II-IIIA non-small cell lung cancer MedDRA version: 9.1 Level: SOC Classification code 10038738 Term: Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: ANZATAX
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Paclitaxel
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number: 200-
Sponsors
Azienda Ospedaliero Universitaria ''San Luigi Gonzaga''
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate overall survival in patients with completely resected Stage II-IIIA non-small cell lung cancer (NSCLC) treated with tailored adjuvant chemotherapy driven by the assessment of the pharmacogenomic profile of the resected primary tumor as investigated by quantitative real time polymerase chain reaction (qRT-PCR) of paraffin embedded specimens or with standard cisplatin-based adjuvant chemotherapy selected by the investigator (cisplatin/vinorelbine, cisplatin/docetaxel or cisplatin/gemcitabine).;Secondary Objective: To evaluate recurrence-free survival with tailored adjuvant chemotherapy driven by the assessment of the pharmacogenomic profile of the resected primary tumor as investigated by qRT-PCR of paraffin embedded specimens or with standard adjuvant chemotherapy selected by the investigator (cisplatin/vinorelbine, cisplatin/docetaxel or cisplatin/gemcitabine);Primary end point(s): Overall survival | — |
Countries
Germany, Italy
Outcome results
None listed