Neoadjuvant treatmento for early stage non small cell lung cancer MedDRA version: 9.1 Level: LLT Classification code 10061873 Term: Non-small cell lung cancer
Conditions
Interventions
Trade Name: GEMZAR INFUS 1FL 1G POLV
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Gemcitabine
CAS Number: 122111-03-9
Concentration unit: mg milligram(s)
Concentration type: equal
Co
Sponsors
ISTITUTI FISIOTERAPICI OSPITALIERI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients must have pathologic documentation either histologic or cytologic of non-small cell lung cancer. 5.2 All patients must have a. Clinical Stage IB T2N0 negative mediastinoscopy or no enlarged 1 cm mediastinal lymph nodes on CT scan, no evidence of N1 disease on imaging studies OR b. Clinical Stage II T1 - 2N1 negative mediastinoscopy or no enlarged 1 cm mediastinal or hilar only level 10 lymph nodes on CT scan , T3N0 negative mediastinoscopy or no enlarged 1 cm mediastinal lymph nodes on CT scan c. Pathological Stage IIIA T1-3 pN2 confirmed by FNAB/mediastinoscopy/mediastinotomy and suitable for radical surgery 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: Uncontrolled diabetes mellitus. Patients must not have psychological, familial, sociological or geographical conditions that do not permit weekly medical follow-up and compliance with the study protocol. Patients must not have Grade 1 neuropathy - motor/sensory as judged by the investigator. Patients must not have dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent. Patient must not have significant history of cardiac disease, i.e., uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the past year, or cardiac ventricular arrhythmias requiring medication. Patients must not have any immediate life-threatening complications of their malignancies. Patients must not have pleural effusion and/or N3 disease. Patients should not receive any other investigational drugs post-surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether preoperative chemotherapy with gemcitabine and cisplatin for 3 cycles improves survival compared to postoperative chemotherapy with the very same regimen in previously untreated patients with clinical Stage IB, II and IIIA non-small cell lung cancer NSCLC .;Secondary Objective: To compare the progression-free survival PFS and sites of relapse in the two study arms. To compare quality of life of patients and patient preference in the two study arms. To compare the rate of actual delivered chemotherapy in the two arms. To compare operative mortality and other toxicities in the two study arms. To evaluate the response rates and the toxicities associated with the combination of gemcitabine and cisplatin. To evaluate the outcome of patients obtaining pathological complete response after preoperative chemotherapy. To obtain samples for correlation of radiologic, pathologic, molecular and biologic factors with outcome.;Primary end point(s): Overall survival | — |
Countries
Italy
Outcome results
None listed