- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00526396
STAD-1 Small Cell Lung Cancer Toxicity Adjusted Dosing Study (STAD-1)
March 23, 2023 updated by: National Cancer Institute, Naples
Multicenter Randomized Phase III Study Comparing Fixed Doses Versus Toxicity Adjusted Dosing of Cisplatin and Etoposide for Patients With Small Cell Lung Cancer.
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
160
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Alba, Italy
- Ospedale San Lazzaro
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Catanzara, Italy
- Ospedale Mater Domini
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Milano, Italy
- Ospedale L. Sacco Polo Universitario
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Napoli, Italy
- Istituto Nazionale dei Tumori
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Napoli, Italy
- Ospedale Cotugno
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Piacenza, Italy
- Ospedale Guglielmo da Saliceto
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Trieste, Italy
- Ospedale Maggiore
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AV
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Monteforte Irpino, AV, Italy
- Azienda Sanitaria S. Giuseppe Moscati
-
-
BN
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Benevento, BN, Italy
- Azienda Ospedaliera G. Rummo
-
-
PA
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Palermo, PA, Italy, 90146
- Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico
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PD
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Padova, PD, Italy
- Istituto Oncologico Veneto
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SO
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Sondalo, SO, Italy, 23039
- Ospedale E. Morelli
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A
standard fixed doses
|
80 mg/m2 on day 1 for 6 cycles
100 mg/m2 on days 1,2,3 for 6 cycles
cisplatin on day 1 for 6 cycles, starting dose 80 mg/m2, toxicity adjusted after first cycle
etoposide on days 1,2,3 for 6 cycles, starting dose 100 mg/m2, toxicity adjusted dosing after first cycle
|
Experimental: B
toxicity adjusted dosing
|
80 mg/m2 on day 1 for 6 cycles
100 mg/m2 on days 1,2,3 for 6 cycles
cisplatin on day 1 for 6 cycles, starting dose 80 mg/m2, toxicity adjusted after first cycle
etoposide on days 1,2,3 for 6 cycles, starting dose 100 mg/m2, toxicity adjusted dosing after first cycle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
objective response
Time Frame: after 3 and 6 cycles of chemotherapy
|
after 3 and 6 cycles of chemotherapy
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
toxicity
Time Frame: during and after each treatment cycle
|
during and after each treatment cycle
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Massimo Di Maio, M.D., Giannettasio Hospital, Department of Oncology and Hematology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
September 6, 2007
First Submitted That Met QC Criteria
September 6, 2007
First Posted (Estimate)
September 10, 2007
Study Record Updates
Last Update Posted (Actual)
March 24, 2023
Last Update Submitted That Met QC Criteria
March 23, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Etoposide
- Etoposide phosphate
- Cisplatin
Other Study ID Numbers
- STAD-1
- 2006-003995-36 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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