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

  • Italy
      • Alba, Italy
        • Ospedale San Lazzaro
      • Catanzara, Italy
        • Ospedale Mater Domini
      • Milano, Italy
        • Ospedale L. Sacco Polo Universitario
      • Napoli, Italy
        • Istituto Nazionale Dei Tumori
      • Napoli, Italy
        • Ospedale Cotugno
      • Piacenza, Italy
        • Ospedale Guglielmo da Saliceto
      • Trieste, Italy
        • Ospedale Maggiore
    • AV
      • Monteforte Irpino, AV, Italy
        • Azienda Sanitaria S. Giuseppe Moscati
    • BN
      • Benevento, BN, Italy
        • Azienda Ospedaliera G. Rummo
    • PA
      • Palermo, PA, Italy, 90146
        • Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico
    • PD
      • Padova, PD, Italy
        • Istituto Oncologico Veneto
    • SO
      • 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
Drug: cisplatin
80 mg/m2 on day 1 for 6 cycles
Drug: etoposide
100 mg/m2 on days 1,2,3 for 6 cycles
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
Experimental: B
toxicity adjusted dosing
Drug: cisplatin
80 mg/m2 on day 1 for 6 cycles
Drug: etoposide
100 mg/m2 on days 1,2,3 for 6 cycles
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

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.

Sponsor

National Cancer Institute, Naples

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.

General Publications

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

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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