E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Locally advanced non small cell lung cancer |
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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 estimate the effect of CT-RT on pCR in resectable patients |
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E.2.2 | Secondary objectives of the trial |
- To estimate the effect of CT alone on pCR in marginally resectable patients - To evaluate the clinical OR rate of complete surgery (R0 rate), event free survival and overall survival - To assess tolerance |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients aged between 18 and 75 years - Histologically or cytologically (fine needle aspiration) proven non-small cell lung cancer (NSCLC) - Untreated locally advanced inoperable stage IIIA (only pN2 confirmed by mediastinoscopy) - Patients with a Karnofsky Performance Status ³ 80% - Adequate pulmonary function - Life expectancy > 12 weeks - Patients without weight loss > 10% within the previous 3 months - Adequate bone marrow, hepatic and renal functions (Neutrophils ³ 2.0 x 109/L-Platelets ³ 100 x 109/L, Haemoglobin ³ 12 g/dL, Total bilirubin £ 1.5 x ULN, Transaminases £ 2.5 x ULN, Alkaline phosphatase < 5 x ULN, Glomerular Filtration Rate ³ 65 mL/min per 1.73 m2· - Presence of at least one measurable lesion (RECIST) - Absence of any psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol - Absence of current or recent (within 2 weeks before registration) severe infection - Absence of renal or hearing impairment - Women of childbearing potential must be using a medically accepted method of contraception (i.e. oral contraceptives, intrauterine devices) to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment in such a manner that the risk of pregnancy is minimised. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study treatment - Fertile men must be using an effective method of birth control if their partners are women of childbearing potential - Patients who give written (personally signed and dated) inform consent before completing any study-related procedure.
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E.4 | Principal exclusion criteria |
- Patients with NSCLC stages I, II, bulky IIIA (except pN2 confirmed by mediastinoscopy), IIIB and IV - With tumour extent or location precluding radical radiotherapy as specified in the protocol -Symptomatic neuropathy (sensory) > grade 1 according to the NCI Common Toxicity Criteria - Hearing impairment ³ Grade 2 - Concomitant/uncontrolled medical disorder (cardiac failure or myocardial infarction within the previous 3 months; uncontrolled hypertension or arrhythmia; uncontrolled hypercalcaemia; active infection requiring I.V. antibiotics within 2 weeks before the beginning of treatment) - Weight loss > 10% within the previous 3 months - Pre-existing malignant pleural effusion - Ascites or pericardial effusion - Active secondary malignancy except appropriately treated carcinoma in situ of the cervix or skin basal cell cancer. Patients with a history of cancer and at least five years of uneventful follow up and no signs of recurrence may be eligible. - Previous or concomitant treatment with other anticancer drugs during the last 5 years - Known hypersensitivity to the study drugs or to drugs with similar chemical structures - Concomitant treatment with systemic corticosteroids except chronic treatment lasting more than 1 month at low doses (£ 20 mg/day of methyl prednisolone or equivalent) - Significant malabsorption syndrome or disease affecting the gastrointestinal tract function and the absorption of oral drugs - Women if pregnant or breast-feeding or with Positive pregnancy test at inclusion - Male or female of childbearing potential who is unwilling or unable to use a medically accepted method to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and at least 3 months following the last dose of study treatment - Participation to another clinical trial with any investigational drug study (whatever the use, curative, prophylactic or diagnostic intent) within 30 days prior to registration. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Pathological complete response rate (pCR) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
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) | Yes |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 9 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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The end of study is defined as the date of progression or relapse for the last evaluable patient, taking into account all randomised patients |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |