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 | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10026532 |
E.1.2 | Term | Malignant neoplasm of thorax |
|
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 |
evaluate the percentage of patients without progression (PFS) at one year from the CT start. |
|
E.2.2 | Secondary objectives of the trial |
- 1 year PFS rate from the maintaining treatment start - Objective response rate according to RECIST criteria (see appendix A) - Safety (toxicity) - 2 years overall survival |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1 Cytologic or hystologic diagnosis of Small Cell Lung Cancer (SCLC) 2 Performance Score < 2 (see Appendix A) 3 Age > 18 and < 75 years 4 Life expectancy of greater than 6 months 5 Extended stage of SCLC 6 Patient pre-treated with standard 1 st line chemotherapy: CDDP 75 mg/mq Day 1 or Carboplatin 300 mg/mq Day 1 or Carboplatin AUC 5 Day 1 and VP-16 100 mg/mq Days 1-3 every 21 days. 7 Patient with SD, PR or CR after a first line CT 8 Positive Octreoscan or PET/CT 68Ga-DOTANOC (cut/off > 1:1 from tumor and liver) or Positive stain of Somatostatin Receptor type 2 at the paraffin inclusions (histological revision will be centralized. Patients will be enrolled based on the local histological diagnosis) 9 Presence of at least of one measurable lesion in agreement to RECIST criteria 10 Patients must have normal organ and marrow function as defined below: - leukocytes >3,000/L - absolute neutrophil count >1,500/L - platelets >100,000/L - total bilirubin < 1.5 X institutional upper normal limits - AST(SGOT)/ALT(SGPT) <2.5 X institutional upper normal limits - Serum creatinine < 1.25 xULN (except in case of creatinine > 1.25 x ULN and ≤ 1.5 x ULN if creatinine clearance is > 60 ml/min) 11 Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 12 Ability to understand and the willingness to sign a written informed consent document. 13 Geographic accessibility |
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E.4 | Principal exclusion criteria |
1 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 2 Concomitant chemo-radiotherapic treatment 3 Previous diagnosis of tumor in the last 5 years, excluded non-melanoma skin cancer, carcinoma in situ of the cervix 4 Participation in another clinical trial with any investigational agents within 30 days prior to study screening 5 Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; women in lactation period must be escluded; |
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E.5 End points |
E.5.1 | Primary end point(s) |
evaluate the percentage of patients without progression (PFS) at one year from the CT start. |
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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 | No |
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) | 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
| 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 | 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 |