STAD-1 Small Cell Lung Cancer Toxicity Adjusted Dosing Study

Small Cell Lung Cancer Clinical Trial

— STAD-1  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00526396
• Other study ID #: STAD-1
• Secondary ID: 2006-003995-36
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 2007
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 70 Years

Eligibility

Inclusion Criteria:

• Cytologic or histologic diagnosis of small cell lung cancer

• Extensive disease according to VALG classification

• One or more target lesions.

• Performance status (ECOG) 0 or 1

• Age <70 years.

• Patients with asymptomatic cerebral metastases are eligible

• Patients who have completed treatment with radiation therapy at least 4 weeks prior to enrollment are eligible

• Written informed consent

Exclusion Criteria:

• Previous chemotherapy

• Previous or concomitant malignant neoplasm (excluding adequately treated baso or spinocellular skin carcinoma or carcinoma in situ of the cervix)

• Neutrophil < 2000/mm3, platelets < 100,000/mm3, haemoglobin < 10 g/dl

• Creatinine > 1.5 x the upper normal limits

• GOT and/or GPT > 2.5 and/or Bilirubin > 1.5 times the upper normal limits in absence of hepatic metastases

• GOT and/or GPT > 5 and/or Bilirubin > 3 times the upper normal limits in presence of hepatic metastases

• Any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study

• Hypersensitivity to darbepoetin alpha, to r-HuEPO or their components

• Uncontrolled hypertension.

• Inability to provide informed consent.

• Inability to comply with follow-up

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• cisplatin
80 mg/m2 on day 1 for 6 cycles
• etoposide
100 mg/m2 on days 1,2,3 for 6 cycles
• cisplatin
cisplatin on day 1 for 6 cycles, starting dose 80 mg/m2, toxicity adjusted after first cycle
• etoposide
etoposide on days 1,2,3 for 6 cycles, starting dose 100 mg/m2, toxicity adjusted dosing after first cycle

Locations

Country	Name	City	State
Italy	Ospedale San Lazzaro	Alba
Italy	Azienda Ospedaliera G. Rummo	Benevento	BN
Italy	Ospedale Mater Domini	Catanzara
Italy	Ospedale L. Sacco Polo Universitario	Milano
Italy	Azienda Sanitaria S. Giuseppe Moscati	Monteforte Irpino	AV
Italy	Istituto Nazionale dei Tumori	Napoli
Italy	Ospedale Cotugno	Napoli
Italy	Istituto Oncologico Veneto	Padova	PD
Italy	Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico	Palermo	PA
Italy	Ospedale Guglielmo da Saliceto	Piacenza
Italy	Ospedale E. Morelli	Sondalo	SO
Italy	Ospedale Maggiore	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response		after 3 and 6 cycles of chemotherapy
Secondary	toxicity		during and after each treatment cycle