NCT00526396

STAD-1 Small Cell Lung Cancer Toxicity Adjusted Dosing Study

Multicenter Randomized Phase III Study Comparing Fixed Doses Versus Toxicity Adjusted Dosing of Cisplatin and Etoposide for Patients With Small Cell Lung Cancer.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The standard treatment for advanced small cell lung cancer (SCLC) is combination chemotherapy of cisplatin or carboplatin with etoposide. Standard fixed doses of this combination have been based on calculating a patient's body surface area. This method of dose calculation has been shown to be poorly correlated with the activity of many chemotherapy drugs, and some patients do not obtain adequate levels of the drug in their circulation. Recent reports suggest that patients who have a very high tolerability to chemotherapy (without significant toxicity), are at risk for having less effectiveness of the therapy. This study will compare fixed doses of standard chemotherapy with a new strategy of the same chemotherapy with doses that will be adjusted according to the toxicity observed.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-09-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2007-09-10
• Last updated: 2023-03-24

Locations

12 sites across 1 country: Italy