STAD-1 Small Cell Lung Cancer Toxicity Adjusted Dosing Study
This trial is active, not recruiting.
|Condition||small cell lung cancer|
|Sponsor||National Cancer Institute, Naples|
|Start date||September 2007|
|End date||January 2016|
|Trial size||160 participants|
|Trial identifier||NCT00526396, 2006-003995-36, STAD-1|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Monteforte Irpino, Italy||Azienda Sanitaria S. Giuseppe Moscati||no longer recruiting|
|Benevento, Italy||Azienda Ospedaliera G. Rummo||no longer recruiting|
|Palermo, Italy||Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico||no longer recruiting|
|Padova, Italy||Istituto Oncologico Veneto||no longer recruiting|
|Sondalo, Italy||Ospedale E. Morelli||no longer recruiting|
|Alba, Italy||Ospedale San Lazzaro||no longer recruiting|
|Catanzara, Italy||Ospedale Mater Domini||no longer recruiting|
|Milano, Italy||Ospedale L. Sacco Polo Universitario||no longer recruiting|
|Napoli, Italy||Istituto Nazionale dei Tumori||no longer recruiting|
|Napoli, Italy||Ospedale Cotugno||no longer recruiting|
|Piacenza, Italy||Ospedale Guglielmo da Saliceto||no longer recruiting|
|Trieste, Italy||Ospedale Maggiore||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
time frame: after 3 and 6 cycles of chemotherapy
time frame: during and after each treatment cycle
Male or female participants up to 70 years old.
- 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
- 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
|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.|
|Principal investigator||Cesare Gridelli, M.D.|
|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.|
Call for more information