Clinical trial · Interventional
STAD-1 Small Cell Lung Cancer Toxicity Adjusted Dosing Study
Multicenter Randomized Phase III Study Comparing Fixed Doses Versus Toxicity Adjusted Dosing of Cisplatin and Etoposide for Patients With Small Cell Lung Cancer.
NCT00526396CI-TRIAL-00065013STAD-1unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- standard fixed doses
- interventionNames
- Drug: cisplatin
- Drug: etoposide
- type
- EXPERIMENTAL
- label
- B
- description
- toxicity adjusted dosing
- interventionNames
- Drug: cisplatin
- Drug: etoposide
Primary outcomes (1)
- measure
- objective response
- timeFrame
- after 3 and 6 cycles of chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMorabito 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