Small Cell Lung CancerPhase 3STAD-1NCT00526396
STAD-1 Small Cell Lung Cancer Toxicity Adjusted Dosing Study
A Phase 3 study testing cisplatin and etoposide in people with Small Cell Lung Cancer, run by National Cancer Institute, Naples at 12 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- cisplatin and etoposide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 12 sitesItaly
- Study dates
- Sep 2007to Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Italy12 sites
Ospedale San Lazzaro
Alba
Azienda Ospedaliera G. Rummo
Benevento, BN
Ospedale Mater Domini
Catanzaro
Ospedale L. Sacco Polo Universitario
Milan
Azienda Sanitaria S. Giuseppe Moscati
Monteforte Irpino, AV
Istituto Nazionale dei Tumori
Naples
Ospedale Cotugno
Naples
Istituto Oncologico Veneto
Padova, PD
Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico
Palermo, PA, 90146
Ospedale Guglielmo da Saliceto
Piacenza
Ospedale E. Morelli
Sondalo, SO, 23039
Ospedale Maggiore
Trieste
About this study
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.
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.
Read the 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
- Keywords
- chemotherapy, toxicity adjusted dose
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
80 mg/m2 on day 1 for 6 cycles
etoposideDrug
100 mg/m2 on days 1,2,3 for 6 cycles
cisplatinDrug
cisplatin on day 1 for 6 cycles, starting dose 80 mg/m2, toxicity adjusted after first cycle
etoposideDrug
etoposide on days 1,2,3 for 6 cycles, starting dose 100 mg/m2, toxicity adjusted dosing after first cycle
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | standard fixed doses Receives: Drug: cisplatin; Drug: etoposide |
| B | Experimental | toxicity adjusted dosing Receives: Drug: cisplatin; Drug: etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response
Measured: after 3 and 6 cycles of chemotherapy
Secondary outcomes (1)
toxicity
Measured: during and after each treatment cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cesare Gridelli, M.D., Principal investigator, S.G. Moscati Hopital, Avellino, Italy, Division of Medical OncologyMassimo Di Maio, M.D., Principal investigator, Giannettasio Hospital, Department of Oncology and HematologyFrancesco Perrone, M.D., Ph.D, Principal investigator, National Cancer Institute Naples, Italy; Director Clinical Trials UnitCiro Gallo, M.D., Ph.D, Principal investigator, Second University of Naples, Italy; Chair of Medical Statistics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526396
- Sponsor's protocol ID
- STAD-1
- Other IDs
- 2006-003995-36
- Acronym
- STAD-1
- Status last verified
- Mar 2023
- First submitted
- 6 Sep 2007
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28625627
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00526396
- Acronym / sponsor ID
- STAD-1 / STAD-1
- Conditions
- Small Cell Lung Cancer
- Keywords
- chemotherapy, toxicity adjusted dose
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 10 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: cisplatin, Drug: etoposidestandard fixed doses |
| B | Experimental | Drug: cisplatin, Drug: etoposidetoxicity adjusted dosing |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cisplatin80 mg/m2 on day 1 for 6 cycles | Drug | A |
| etoposide100 mg/m2 on days 1,2,3 for 6 cycles | Drug | A |
| cisplatincisplatin on day 1 for 6 cycles, starting dose 80 mg/m2, toxicity adjusted after first cycle | Drug | B |
| etoposideetoposide on days 1,2,3 for 6 cycles, starting dose 100 mg/m2, toxicity adjusted dosing after first cycle | Drug | B |
Primary outcome
objective response
Time frame: after 3 and 6 cycles of chemotherapy
1 secondary outcome
toxicity
Time frame: during and after each treatment cycle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Derived from this study: PubMed 28625627Morabito 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cesare Gridelli, M.D. principal investigator
S.G. Moscati Hopital, Avellino, Italy, Division of Medical Oncology
Massimo Di Maio, M.D. principal investigator
Giannettasio Hospital, Department of Oncology and Hematology
Francesco Perrone, M.D., Ph.D principal investigator
National Cancer Institute Naples, Italy; Director Clinical Trials Unit
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cisplatin and etoposide in people with Small Cell Lung Cancer, run by National Cancer Institute, Naples at 12 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response (time frame: after 3 and 6 cycles of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00526396, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.