MedTrace Logo

STAD-1 Small Cell Lung Cancer Toxicity Adjusted Dosing Study

NCT00526396 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2023-03-24

No results posted yet for this study

Summary

The purpose of this study is to compare the activity of fixed doses of cisplatin and etoposide with toxicity adjusted dosing of the same drugs in the first-line treatment of small cell lung cancer.

Conditions

Interventions

DRUG

cisplatin

80 mg/m2 on day 1 for 6 cycles

DRUG

etoposide

100 mg/m2 on days 1,2,3 for 6 cycles

DRUG

cisplatin

cisplatin on day 1 for 6 cycles, starting dose 80 mg/m2, toxicity adjusted after first cycle

DRUG

etoposide

etoposide on days 1,2,3 for 6 cycles, starting dose 100 mg/m2, toxicity adjusted dosing after first cycle

Sponsors & Collaborators

  • National Cancer Institute, Naples

    lead OTHER

Principal Investigators

  • Cesare Gridelli, M.D. · S.G. Moscati Hopital, Avellino, Italy, Division of Medical Oncology

  • Massimo Di Maio, M.D. · Giannettasio Hospital, Department of Oncology and Hematology

  • Francesco Perrone, M.D., Ph.D · National Cancer Institute Naples, Italy; Director Clinical Trials Unit

  • Ciro Gallo, M.D., Ph.D · Second University of Naples, Italy; Chair of Medical Statistics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00526396 on ClinicalTrials.gov