E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non-small cell lung cancer, stage III |
|
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 | 10029520 |
E.1.2 | Term | Non-small cell lung cancer stage IIIA |
|
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 | 10029521 |
E.1.2 | Term | Non-small cell lung cancer stage IIIB |
|
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 |
|
E.2.2 | Secondary objectives of the trial |
• Progression free survival • 2 year survival • Late and acute Toxicity (CTCAE version 3.0-appendix 2) • Compliance to treatment • Response rate to concurrent CTRT
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
a) Histologically or cytologically confirmed NSCLC (mixed small cell, non-small cell histology is not permitted) b) Inoperable Stage III disease (T4N0/1; T4N2; any TN3) confirmed by PET scanning, mediastinoscopy or thoracoscopy. c) Tumour judged inoperable by a thoracic surgeon d) Measurable or evaluable disease on CT scan e) Age >= 18, no upper age limit f) Performance status - ECOG 0 or 1 (appendix 1) g) No prior chemotherapy, radiotherapy or investigational agents h) Willing and able to give informed consent i) Patient considered able to tolerate platinum based chemotherapy and radical radiotherapy: • Creatinine clearance >= 50 ml/min. The Cockcroft and Gault formula (see appendix 5) may be used to estimate GFR, but if <60 ml/min then EDTA clearance should be performed. • Adequate bone marrow reserve (i.e. white cell count > 4 x 109/l, absolute neutrophil count > 1.5 x 109/l, haemoglobin > 10.0 g/dl and platelet count >100 x 109/l). • Tumour that can be encompassed within a radical radiotherapy treatment volume (V20 expected to be < 35% - see section 4.3.2) • FEV1 >= 1.0 L or DLCO (transfer factor) >= 50% of predicted
|
|
E.4 | Principal exclusion criteria |
a) Stage IIIb wet (cytologically proven malignant pleural effusion). Pleural effusion permitted if it developed after exploratory surgery or mediastinoscopy or if present only on CT scan and deemed too small to tap under ultrasound or CT guidance. b) Pericardial effusion c) Other previous or current malignant disease likely to interfere with protocol treatment or comparisons d) Abnormal LFTs with any of: alkaline phosphatase, gammaGT, transaminases or bilirubin >1.5 times upper limit of normal range e) Calcium above normal limits f) Superior vena cava symdrome, haemoptysis causing a decrease in Hb of >=1g/L g) V20 > 35% (see section 4.3.2) g)h) Medically unstable (e.g. unstable diabetes, uncontrolled arterial hypertension, infection, hypercalcaemia or ischaemic heart disease) h)i) Patients who are pregnant or lactating. j) Patients (of reproductive potential) who are unable to comply with effective contraception if sexually active during the study and for a period of at least 6 months after treatment. k) Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose = 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).”
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
|
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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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 | 0 |
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 |
E.8.9.2 | In all countries concerned by the trial days | 0 |