oncological patients MedDRA version: 12.1 Level: LLT Classification code 10026532 Term: Malignant neoplasm of thorax
Conditions
Interventions
Product Name: 177Lu-DOTA-Tyr3-Octreotate
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: 177LuDOTATATE
Concentration unit: mCi millicurie(s)
Concentration type: equal
Concentration num
Sponsors
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Cytologic or hystologic diagnosis of Small Cell Lung Cancer (SCLC) 2 Performance Score 18 and 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 1.25 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
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: evaluate the percentage of patients without progression (PFS) at one year from the CT start.;Secondary Objective: - 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;Primary end point(s): evaluate the percentage of patients without progression (PFS) at one year from the CT start. | — |
Countries
Italy
Outcome results
None listed