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

Primary Purpose

Small Cell Lung Cancer

Status
Active
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
cisplatin
etoposide
cisplatin
etoposide
Sponsored by
National Cancer Institute, Naples
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring chemotherapy, toxicity adjusted dose

Eligibility Criteria

undefined - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Azienda Sanitaria S. Giuseppe Moscati
  • Azienda Ospedaliera G. Rummo
  • Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico
  • Istituto Oncologico Veneto
  • Ospedale E. Morelli
  • Ospedale San Lazzaro
  • Ospedale Mater Domini
  • Ospedale L. Sacco Polo Universitario
  • Istituto Nazionale dei Tumori
  • Ospedale Cotugno
  • Ospedale Guglielmo da Saliceto
  • Ospedale Maggiore

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A

B

Arm Description

standard fixed doses

toxicity adjusted dosing

Outcomes

Primary Outcome Measures

objective response

Secondary Outcome Measures

toxicity

Full Information

First Posted
September 6, 2007
Last Updated
March 23, 2023
Sponsor
National Cancer Institute, Naples
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1. Study Identification

Unique Protocol Identification Number
NCT00526396
Brief Title
STAD-1 Small Cell Lung Cancer Toxicity Adjusted Dosing Study
Acronym
STAD-1
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 Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute, Naples

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
chemotherapy, toxicity adjusted dose

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
standard fixed doses
Arm Title
B
Arm Type
Experimental
Arm Description
toxicity adjusted dosing
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
80 mg/m2 on day 1 for 6 cycles
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Description
100 mg/m2 on days 1,2,3 for 6 cycles
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
cisplatin on day 1 for 6 cycles, starting dose 80 mg/m2, toxicity adjusted after first cycle
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Description
etoposide on days 1,2,3 for 6 cycles, starting dose 100 mg/m2, toxicity adjusted dosing after first cycle
Primary Outcome Measure Information:
Title
objective response
Time Frame
after 3 and 6 cycles of chemotherapy
Secondary Outcome Measure Information:
Title
toxicity
Time Frame
during and after each treatment cycle

10. Eligibility

Sex
All
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cesare Gridelli, M.D.
Organizational Affiliation
S.G. Moscati Hopital, Avellino, Italy, Division of Medical Oncology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Massimo Di Maio, M.D.
Organizational Affiliation
Giannettasio Hospital, Department of Oncology and Hematology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francesco Perrone, M.D., Ph.D
Organizational Affiliation
National Cancer Institute Naples, Italy; Director Clinical Trials Unit
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ciro Gallo, M.D., Ph.D
Organizational Affiliation
Second University of Naples, Italy; Chair of Medical Statistics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Sanitaria S. Giuseppe Moscati
City
Monteforte Irpino
State/Province
AV
Country
Italy
Facility Name
Azienda Ospedaliera G. Rummo
City
Benevento
State/Province
BN
Country
Italy
Facility Name
Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico
City
Palermo
State/Province
PA
ZIP/Postal Code
90146
Country
Italy
Facility Name
Istituto Oncologico Veneto
City
Padova
State/Province
PD
Country
Italy
Facility Name
Ospedale E. Morelli
City
Sondalo
State/Province
SO
ZIP/Postal Code
23039
Country
Italy
Facility Name
Ospedale San Lazzaro
City
Alba
Country
Italy
Facility Name
Ospedale Mater Domini
City
Catanzara
Country
Italy
Facility Name
Ospedale L. Sacco Polo Universitario
City
Milano
Country
Italy
Facility Name
Istituto Nazionale dei Tumori
City
Napoli
Country
Italy
Facility Name
Ospedale Cotugno
City
Napoli
Country
Italy
Facility Name
Ospedale Guglielmo da Saliceto
City
Piacenza
Country
Italy
Facility Name
Ospedale Maggiore
City
Trieste
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
28625627
Citation
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.
Results Reference
derived

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STAD-1 Small Cell Lung Cancer Toxicity Adjusted Dosing Study

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