STAD-1 Small Cell Lung Cancer Toxicity Adjusted Dosing Study

NCT00526396 | Unknown Phase 3

• 2 other identifiers: STAD-12006-003995-36
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 12

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.

Conditions

Small Cell Lung Cancer

Keywords

chemotherapy; toxicity adjusted dose

Outcome Measures

Primary Outcomes (1)

• objective response

  after 3 and 6 cycles of chemotherapy

Secondary Outcomes (1)

• toxicity

  during and after each treatment cycle

Study Arms (2)

A

ACTIVE COMPARATOR

standard fixed doses

Drug: cisplatin; Drug: etoposide

B

EXPERIMENTAL

toxicity adjusted dosing

Drug: cisplatin; Drug: etoposide

Interventions

cisplatin DRUG

80 mg/m2 on day 1 for 6 cycles

A

etoposide DRUG

100 mg/m2 on days 1,2,3 for 6 cycles

A

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (12)

Azienda Sanitaria S. Giuseppe Moscati

Monteforte Irpino, AV, Italy

Location

Azienda Ospedaliera G. Rummo

Benevento, BN, Italy

Location

Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico

Palermo, PA, 90146, Italy

Location

Istituto Oncologico Veneto

Padua, PD, Italy

Location

Ospedale E. Morelli

Sondalo, SO, 23039, Italy

Location

Ospedale San Lazzaro

Alba, Italy

Location

Ospedale Mater Domini

Catanzaro, Italy

Location

Ospedale L. Sacco Polo Universitario

Milan, Italy

Location

Istituto Nazionale dei Tumori

Napoli, Italy

Location

Ospedale Cotugno

Napoli, Italy

Location

Ospedale Guglielmo da Saliceto

Piacenza, Italy

Location

Ospedale Maggiore

Trieste, Italy

Location

Related Publications (1)

• Morabito A, Daniele G, Costanzo R, Favaretto AG, Filipazzi V, Rossi A, Gebbia V, Castiglione F, Cavanna L, Maiello E, Sandomenico C, Bonanno L, Piazza E, Maione P, Piccirillo MC, Di Maio M, Rocco G, Gallo C, Perrone F, Gridelli C. A multicenter, randomized, phase 3 trial comparing fixed dose versus toxicity-adjusted dose of cisplatin + etoposide in extensive small-cell lung cancer (SCLC) patients: The Small-cell-lung cancer Toxicity Adjusted Dosing (STAD-1) trial. Lung Cancer. 2017 Jun;108:15-21. doi: 10.1016/j.lungcan.2017.02.016. Epub 2017 Feb 27.

  PMID: 28625627 DERIVED

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Cisplatin; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2007
• First Posted: September 10, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

IT (12)