E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Stage II-III Non small lung cancer |
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E.1.1.1 | Medical condition in easily understood language |
Stage II-III Non small lung cancer |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
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 |
• To assess the impact of individualized and escalated dose prescription based on FDG-PET on the tumor local control, the local progression-free survival and overall survival. • To secondarily assess early and late radio-induced toxicities
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E.2.2 | Secondary objectives of the trial |
To appraise the impact of potential tumor modifications during the treatment course for both volumetric and dosimetric changes by using repeated PET imaging with conventional tracer (FDG) and tracer of hypoxia (FAZA) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Histologically proven NSCLC • Non resectable stage III or medically inoperable stage II disease when a stereotactic treatment cannot be proposed • No contraindication for induction or concomitant chemotherapy • No prior thoracic radiation • Moderate-to-good lung function with : o FEV1/DLCO ≥ 30% of the predicted value o FEV1 ≥ 1L
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E.4 | Principal exclusion criteria |
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E.5 End points |
E.5.1 | Primary end point(s) |
a) Assess the metabolic response b) Acute toxicity and assessment of quality of life c) Follow up: history, physical examination, evaluation of quality of life and toxicities |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Post-treatment FDG-PET will be obtained to assess the metabolic response after 4-8 weeks, 1 and 2 years. FDG-PET will allow to evaluate the local control, the regional control, the distant metastasis, and thus to estimate the progression-free survival rate. Acute toxicity and assessment of quality of life will be scored before the start of radiotherapy (baseline) and weekly during radiation treatment. After the last fraction, patients will be followed up regularly, after 2 weeks, 1 month, 3 months, 6 months, and afterwards at 6-month intervals until 2 years consisting of history, physical examination, evaluation of quality of life and toxicities. |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | No |
E.8.1.1 | Randomised | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
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
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Until 2 years consisting of history, physical examination, evaluation of quality of life and toxicities. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |