STAD-1 Small Cell Lung Cancer Toxicity Adjusted Dosing Study

Phase 3

Active, not recruiting

• Conditions: Small Cell Lung Cancer
• Interventions: Drug: cisplatin; Drug: etoposide

• Registration Number: NCT00526396
• Lead Sponsor: National Cancer Institute, Naples

Brief 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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-06
• Study First Submitted QC: 2007-09-06
• Study First Posted: 2007-09-10
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-24
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 160

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	cisplatin	standard fixed doses
A	etoposide	standard fixed doses
B	cisplatin	toxicity adjusted dosing
B	etoposide	toxicity adjusted dosing

Primary Outcome Measures

Name	Time	Method
objective response	after 3 and 6 cycles of chemotherapy

Secondary Outcome Measures

Name	Time	Method
toxicity	during and after each treatment cycle

Trial Locations

Locations (12)

Ospedale E. Morelli; 🇮🇹 Sondalo, SO, Italy

Istituto Nazionale dei Tumori; 🇮🇹 Napoli, Italy

Ospedale L. Sacco Polo Universitario; 🇮🇹 Milano, Italy

Azienda Sanitaria S. Giuseppe Moscati; 🇮🇹 Monteforte Irpino, AV, Italy

Istituto Oncologico Veneto; 🇮🇹 Padova, PD, Italy

Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico; 🇮🇹 Palermo, PA, Italy

Azienda Ospedaliera G. Rummo; 🇮🇹 Benevento, BN, Italy

Ospedale Mater Domini; 🇮🇹 Catanzara, Italy

Ospedale San Lazzaro; 🇮🇹 Alba, Italy

Ospedale Guglielmo da Saliceto; 🇮🇹 Piacenza, Italy

Ospedale Maggiore; 🇮🇹 Trieste, Italy

Ospedale Cotugno; 🇮🇹 Napoli, Italy