Small Cell Lung Cancer
Conditions
Keywords
SCLC
Brief summary
Comparison of two combination chemotherapies in the treatment of patients with SLCL
Detailed description
Comparison of two combination chemotherapies in the treatment of patients with SLCL The combination chemotherapies for this study are Carboplatin plus Irinotecan versus Carboplatin plus Etoposide.
Interventions
DRUGCarboplatin plus Irinotecan vs Carboplatin plus Etoposide
Sponsors
Pfizer
Aventis Pharmaceuticals
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* cytological or histological proven SCLC Stage I or II at 1st diagnosis * no prior chemotherapy * measurable tumor disease * karnofsky performance 70
Exclusion criteria
* second malignancy ( except basal cell carcinoma, CA in situ Cervix uteri) * NYHA III * chronic diarrhea, obstructive bowel syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Documentation of the remission rate ( Phase II) | — |
| Determination of progress free time (Phase III) | — |
| Primary Endpoint: | — |
Secondary
| Measure | Time frame |
|---|---|
| Documentation of progress free time (Phase II) | — |
| Documentation of objective remission rate ( Phase III) | — |
| Documentation of 1-year survival rate | — |
| Documentation of safety of the drug combination | — |
| Secondary Endpoint: | — |
Countries
Germany
Contacts
Primary ContactUlrich Keilholz, MD
Backup ContactAlexander Schmittel, MD
Outcome results
None listed