E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061873 |
E.1.2 | Term | Non-small cell lung cancer |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
4.1 Inclusion Criteria Cytologic or hystologic diagnosis of Non Small Cell Lung Cancer (NSCLC) ECOG Performance Status &#8804; 1 (see Appendix B) Age > 18 and < 70 years Life expectancy of greater than 3 months Stage IIIA/IIIB proved by TBNA/TTNA or mediastinoscopy Presence of at least of one measurable lesion in agreement to RECIST criteria Patients must have normal organ and marrow function as defined below: - leukocytes >3,000/&#61549;L - absolute neutrophil count >1,500/&#61549;L - platelets >100,000/&#61549;L - total bilirubin within normal institutional limits - AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal - creatinine clearance >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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective is to determine the objective tumor response rate (CR+PR) according to RECIST criteria. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |