Clinical trial · Interventional
A Study to Treat Small Cell Lung Cancer With a Combination of Cisplatin, Pemetrexed, and Radiotherapy
Phase I/II Study of Concurrent Cisplatin, Pemetrexed, and Radiotherapy for Limited Stage Small Cell Lung Cancer
NCT00447421CI-TRIAL-00002740terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Interim results of another trial showed inferior activity of treatment
Summary
Brief summary (as posted)
The purpose of this study is to determine the recommended dose of pemetrexed, cisplatin and radiotherapy in the treatment of patients with Small Cell Lung Cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Small Cell | Small Cell Neuroendocrine Carcinoma | ALIAS | 0.90 |
| SCLC | Lung Small Cell Carcinoma | ALIAS | 0.90 |
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| pemetrexed | Drug | Pemetrexed | ALIAS |
| radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: pemetrexed
- Drug: cisplatin
- Radiation: radiation
Primary outcomes (2)
- measure
- Phase 1: Maximum Tolerated Dose
- timeFrame
- every cycle
- measure
- Phase 2: Overall Response Rate
- timeFrame
- baseline to measured progressive disease
- description
- Overall Response Rate (ORR) was defined as the proportion of participants having either a Complete or Partial response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Measurable disease with diagnosis of Small Cell Lung Cancer. * Performance status of 0 to 1 on the Eastern Cooperative Oncology Group performance status schedule. * Patients must be at least 18 years of age and have at least a 12-week life expectancy. * No prior chemotherapy and/or prior thoracic radiotherapy. * Adequate pulmonary function and organ function. Exclusion Criteria: * Patients with myocardial infarction within the preceding six months. * Diagnosis of a serious concomitant systemic disorder. * Prior radiotherapy to the lower neck or abdominal region. * Significant weight loss. * Concurrent administration of any other antitumor therapy.
References
Publications (0)
Data not yet available
No reference posted for this study.