NSCLC patients MedDRA version: 9.1 Level: LLT Classification code 10061873 Term: Non-small cell lung cancer
Conditions
Interventions
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Cisplatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical Form: Solution for i
Sponsors
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 4.1 Inclusion Criteria Cytologic or hystologic diagnosis of Non Small Cell Lung Cancer (NSCLC) ECOG Performance Status ≤ 1 (see Appendix B) Age > 18 and 3,000/L - absolute neutrophil count >1,500/L - platelets >100,000/L - total bilirubin within normal institutional limits - AST(SGOT)/ALT(SGPT) 60 mg/dL If woman in child-bearing age use of contraceptive methods Ability to understand and the willingness to sign a written informed consent document. 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: 4.2 Exclusion Criteria Diagnosis of Small Cell Lung Cancer (SCLC) Prior neuropaty with neurotoxicity > 2 (NCI/CTC) Obstructive pneumonia Prior chemotherapy and/or radiotherapy Weight loss > 10% in the last 6 months Uncontrolled intercurrent illness including: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Presence of important comorbidities that are contra-indication for systemic cortico steroid therapy (ex. active gastric ulcer, non-counterbalanced diabetes mellitus) Previous diagnosis of tumor in the last 5 years, exclused non-melanoma skin cancer, carcinoma in situ of the cervix Stage IIIA for T3N1 or N2 (< 3 Lymph nodes without extracapsular involvement) or stage IIIB with sovraclavicular and scalenic lymph nodes Pleural and pericardial efflusion Documented implication of esophagus in its all thickness Implication of cardiac ventricals, vertebral foramen and/or spinal marrow Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary end-point of this study is to evaluate the activity of the Cisplatin/Docetaxel in association with short-course of radiotherapy in patients with locally advanced and inoperable NSCLC.;Primary end point(s): The primary objective is to determine the objective tumor response rate (CR+PR) according to RECIST criteria.;Secondary Objective: Secondary end-points are: tolerance to treatment, time to progression and overall survival. This study is planned to perform ancillary analysis as well as: correlation between the tumor biological features and clinical response, analysis of quality of life of the patients and the correlation between the pathological and clinical staging in locally advanced NSCLC | — |
Countries
Italy
Outcome results
None listed