STAD-1 Small Cell Lung Cancer Toxicity Adjusted Dosing Study (STAD-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00526396
Recruitment Status : Unknown
Verified April 2015 by National Cancer Institute, Naples.
Recruitment status was:  Active, not recruiting
First Posted : September 10, 2007
Last Update Posted : April 9, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: cisplatin Drug: etoposide Phase 3

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  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : September 2007
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A
standard fixed doses
Drug: cisplatin
80 mg/m2 on day 1 for 6 cycles
Drug: etoposide
100 mg/m2 on days 1,2,3 for 6 cycles
Experimental: B
toxicity adjusted dosing
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

Primary Outcome Measures :
  1. objective response [ Time Frame: after 3 and 6 cycles of chemotherapy ]

Secondary Outcome Measures :
  1. toxicity [ Time Frame: during and after each treatment cycle ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   up to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00526396

Azienda Sanitaria S. Giuseppe Moscati
Monteforte Irpino, AV, Italy
Azienda Ospedaliera G. Rummo
Benevento, BN, Italy
Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico
Palermo, PA, Italy, 90146
Istituto Oncologico Veneto
Padova, PD, Italy
Ospedale E. Morelli
Sondalo, SO, Italy, 23039
Ospedale San Lazzaro
Alba, Italy
Ospedale Mater Domini
Catanzara, Italy
Ospedale L. Sacco Polo Universitario
Milano, Italy
Istituto Nazionale dei Tumori
Napoli, Italy
Ospedale Cotugno
Napoli, Italy
Ospedale Guglielmo da Saliceto
Piacenza, Italy
Ospedale Maggiore
Trieste, Italy
Sponsors and Collaborators
National Cancer Institute, Naples
Principal Investigator: Cesare Gridelli, M.D. S.G. Moscati Hopital, Avellino, Italy, Division of Medical Oncology
Principal Investigator: Massimo Di Maio, M.D. Giannettasio Hospital, Department of Oncology and Hematology
Principal Investigator: Francesco Perrone, M.D., Ph.D National Cancer Institute Naples, Italy; Director Clinical Trials Unit
Principal Investigator: Ciro Gallo, M.D., Ph.D Second University of Naples, Italy; Chair of Medical Statistics

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: National Cancer Institute, Naples Identifier: NCT00526396     History of Changes
Other Study ID Numbers: STAD-1
2006-003995-36 ( EudraCT Number )
First Posted: September 10, 2007    Key Record Dates
Last Update Posted: April 9, 2015
Last Verified: April 2015

Keywords provided by National Cancer Institute, Naples:
toxicity adjusted dose

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide phosphate
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action