Clinical trial · Interventional
S0004: Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Limited-stage Small Cell Lung Cancer
A Phase I Study Of Tirapazamine/Cisplatin/Etoposide And Concurrent Thoracic Radiotherapy For Limited Stage Small Cell Lung Cancer
- 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have limited-stage 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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
Design
Arms and outcomes
Arms (1)
- type
- ACTIVE_COMPARATOR
- label
- chemo/RT with tirapazamine
- description
- induction and consolidation: cisplatin, etoposide, tirapazamine, radiation therapy
- interventionNames
- Drug: cisplatin
- Drug: etoposide
- Drug: tirapazamine
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Feasibility and Toxicity
- timeFrame
- toxicity is assessed weekly
- description
- If ten or more patients experience either Grade 3 or greater esophagitis or pneumonitis at any dose level, the trial will be stopped. Nine or fewer patients experiencing either of these toxicities will be evidence that the dose can be escalated to the next level.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed limited stage small cell lung cancer (SCLC) * No malignant pericardial or pleural effusions, including any of the following: * Cytologically positive effusions * Exudative effusions not attributable to other etiologies * No brain metastases * Disease (measurable or non-measurable) must be present outside the area of prior surgical resection PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Zubrod 0-1 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT or SGPT no greater than 2 times ULN * Alkaline phosphatase no greater than 2 times ULN Renal: * Creatinine no greater than ULN OR * Creatinine clearance at least 60 mL/min Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No symptomatic sensory neuropathy grade 1 or greater * No other malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other stage I or II cancer in complete remission * No other medical illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior biologic therapy for SCLC Chemotherapy: * No prior systemic chemotherapy for SCLC Endocrine therapy: * Not specified Radiotherapy: * No prior thoracic radiotherapy for SCLC Surgery: * See Disease Characteristics * At least 2 weeks since prior thoracic or other major surgery and recovered
References
Publications (1)
- RESULTLe QT, McCoy J, Williamson S, Ryu J, Gaspar LE, Edelman MJ, Dakhil SR, Sides SD, Crowley JJ, Gandara DR; Southwest oncology group. Phase I study of tirapazamine plus cisplatin/etoposide and concurrent thoracic radiotherapy in limited-stage small cell lung cancer (S0004): a Southwest Oncology Group study. Clin Cancer Res. 2004 Aug 15;10(16):5418-24. doi: 10.1158/1078-0432.CCR-04-0436. PMID 15328179