Clinical trial · Interventional
Chemotherapy and Radiotherapy to Treat Patients With Limited Stage of Small Cell Lung Cancer (SCLC)
Phase II Study of Concurrent Carboplatin, Pemetrexed, and Radiotherapy for Limited Stage of Small Cell Lung Cancer
NCT00494026CI-TRIAL-00002805terminatedPhase 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): Study stopped early based on interim results of another trial, showing inferior activity of pemetrexed/carboplatin compared to etoposide/carboplatin in SCLC.
Summary
Brief summary (as posted)
This is a multicenter, phase II, open-label trial to evaluate the efficacy of pemetrexed + carboplatin combined with thoracic radiotherapy in patients with Limited Stage 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| pemetrexed | Drug | Pemetrexed | ALIAS |
| radiotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pemetrexed + Carboplatin
- interventionNames
- Drug: pemetrexed
- Drug: carboplatin
- Procedure: radiotherapy
Primary outcomes (1)
- measure
- Proportion of Patients With a Complete or Partial Response (Overall Response Rate [ORR])
- timeFrame
- baseline to measured response after chemotherapy and radiation
- 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 (4)
- measure
- Progression-free Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic and/or cytologic diagnosis of Limited Stage of small cell lung cancer * Measurable disease * Good performance status * Adequate bone marrow reserve, hepatic, pulmonary and renal functions Exclusion Criteria: * Serious concomitant systemic disorder * Prior chemotherapy for this cancer and/or prior thoracic radiotherapy * Pregnancy/breast-feeding * Significant weight loss over the previous 6 weeks before study entry * Inability or unwillingness to take vitamin supplementation and corticosteroids
References
Publications (0)
Data not yet available
No reference posted for this study.