Receptorial radiotherapy with 177Lu-DOTA-Tyr3-Octreotate as Maintaining Therapy in Extended Small Cell Lung Cancer (SCLC) after a first standard chemotherapy line - IRST162.02

• Conditions: oncological patients; MedDRA version: 12.1Level: LLTClassification code 10026532Term: Malignant neoplasm of thorax

• Registration Number: EUCTR2010-018333-21-IT
• Lead Sponsor: ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified