E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Local-regionally advanced non-small cell lung cancer. |
|
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 |
|
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 objective of this trial is to test a convenient chemotherapy schedule with an oral formulation of radio-sensitizing Navelbine in concurrent chemo-radiotherapy in radical treatment of inoperable locally advanced non small cell lung cancer (stage IIB-IIIB) with radiotherapy. The trial is a randomized phase II study with two doses of radiotherapy. The primary objective of the study is examine the combination of Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks concomitant with curatively intended irradiation to 60 Gy (2 Gy x 30, 5 F á weeks) or 66 Gy (2 Gy x 33, 5 F á week) starting 3 weeks after two cycles of inductions chemotherapy with Navelbine oral and Carboplatin.
Primary endpoint: - Local failure free survival at 9 months after start of radiotherapy
|
|
E.2.2 | Secondary objectives of the trial |
Secondary endpoints - Toxicity - Local tumour control - Overall response rate (CR + PR) - Local tumour control at 9 months evaluated by PET-CT - Overall survival - Disease free survival - Late toxicity
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age ≥18 years - Patients with histologically or cytologically documented diagnosis of locally advanced NSCLC stage IIB to IIIB without pleural effusion. - Performance status 0-1 on the ECOG scale. - Weight loss ≤10% during the last 6 months - Adequate lung function measured as FEV1 ≥1.0. - Neutrophile count ≥1.5 x 109/L and platelet count ≥100 x 109/L. - Serum bilirubin ≤1.5 upper limit of normal (ULN). - ALAT ≤2 x ULN - Able to comply with study and follow-up procedures - Patients with reproductive potential must use effective contraception. - Written (signed) informed consent to participate in the study.
|
|
E.4 | Principal exclusion criteria |
Exclusion criteria Patients who meet any of the following exclusion criteria are not to be enrolled in this study: - Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, severe hepatic, renal, or metabolic disease). - Any other active malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer). - Prior chemotherapy for lung cancer, including neo- and adjuvant chemotherapy. - Inability to take oral medication, or requirement of intravenous alimentation - Active peptic ulcer disease. - Nursing mothers.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
- Local failure free survival at 9 months after start of radiotherapy |
|
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
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 | No |
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 | 8 |
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
|
The study is expected to recruit patients during a 2-year period starting q2 2009 and ending q2 2011. Analyses of results will be performed 9 months after last patient has been included, and results will be reported. Further analyses may be performed 5 years after last patient has been included. Each site is expected to include between 5-25 patients. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 7 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 7 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |