STAD-1 Small Cell Lung Cancer Toxicity Adjusted Dosing Study

NCT ID: NCT00526396

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2023-12-31

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.

Conditions

Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

standard fixed doses

Group Type: ACTIVE_COMPARATOR

cisplatin

Intervention Type: DRUG

80 mg/m2 on day 1 for 6 cycles

etoposide

Intervention Type: DRUG

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

B

toxicity adjusted dosing

Group Type: EXPERIMENTAL

cisplatin

Intervention Type: DRUG

cisplatin on day 1 for 6 cycles, starting dose 80 mg/m2, toxicity adjusted after first cycle

etoposide

Intervention Type: DRUG

etoposide on days 1,2,3 for 6 cycles, starting dose 100 mg/m2, toxicity adjusted dosing after first cycle

Interventions

cisplatin

80 mg/m2 on day 1 for 6 cycles

Intervention Type: DRUG

etoposide

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

Intervention Type: DRUG

cisplatin

cisplatin on day 1 for 6 cycles, starting dose 80 mg/m2, toxicity adjusted after first cycle

Intervention Type: DRUG

etoposide

etoposide on days 1,2,3 for 6 cycles, starting dose 100 mg/m2, toxicity adjusted dosing after first cycle

Intervention Type: DRUG

Eligibility Criteria

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

• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Naples

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cesare Gridelli, M.D.

Role: PRINCIPAL_INVESTIGATOR

S.G. Moscati Hopital, Avellino, Italy, Division of Medical Oncology

Massimo Di Maio, M.D.

Role: PRINCIPAL_INVESTIGATOR

Giannettasio Hospital, Department of Oncology and Hematology

Francesco Perrone, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute Naples, Italy; Director Clinical Trials Unit

Ciro Gallo, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Second University of Naples, Italy; Chair of Medical Statistics

Locations

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

Istituto Oncologico Veneto

Padua, PD, Italy

Ospedale E. Morelli

Sondalo, SO, Italy

Ospedale San Lazzaro

Alba, , Italy

Ospedale Mater Domini

Catanzaro, , Italy

Ospedale L. Sacco Polo Universitario

Milan, , Italy

Istituto Nazionale dei Tumori

Napoli, , Italy

Ospedale Cotugno

Napoli, , Italy

Ospedale Guglielmo da Saliceto

Piacenza, , Italy

Ospedale Maggiore

Trieste, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 28625627 (View on PubMed)

Other Identifiers

2006-003995-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

STAD-1

Identifier Type: -

Identifier Source: org_study_id