A Study for Small Cell Lung Cancer (SCLC) in Extensive Disease Stage

Charite University, Berlin, Germany286 enrolled

Overview

Comparison of two combination chemotherapies in the treatment of patients with SLCL

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

286

Conditions

Small Cell Lung Cancer

Interventions

Carboplatin plus Irinotecan vs Carboplatin plus EtoposideDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Hematology & Oncology Charité CBF Berlin, Germany

Berlin, State of Berlin, Germany

RECRUITING

Outcomes

Primary Outcomes

Primary Endpoint:

Documentation of the remission rate ( Phase II)

Determination of progress free time (Phase III)

Secondary Outcomes

Secondary Endpoint:

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

Central Contacts

Ulrich Keilholz, MD

CONTACT

+49-30-8445-3596 ulrich.keilholz@charite.de

Alexander Schmittel, MD

CONTACT

+49-30-8445-3090 alexander.schmittel @charite.de

Data from ClinicalTrials.gov

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