Phase 2
Completed N=49
Multicenter Phase 2 Trial Evaluating Cisplatin-Gemcitabine With Concomitant Thoracic Radiotherapy for Treatment of Inoperable Stage III Non Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT00192036 ↗Enrolled (actual)
49
Serious AEs
26.5%
Results posted
Mar 2009
Primary outcomePrimary: Tumor Response at End of Treatment — 1; 18; 3; 1 participants
Summary
The purpose of the study is to evaluate the response rate of patients with non small lung cancer to gemcitabine in combination with radiotherapy. The tolerability and safety of this combination will also be evaluated.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tumor Response at End of Treatment |
1; 18; 3; 1; 22; 4 | — |
| SECONDARY Time to Progressive Disease |
10.9; 11.4 | — |
| SECONDARY Overall Survival |
27.9; 21.8 | — |
| SECONDARY Safety of Induction Chemotherapy |
9; 8; 4; 1 | — |
| SECONDARY Safety of Chemo-radiotherapy |
6; 2; 7; 1; 4; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Inoperable non small cell lung cancer Stage III
- Adequate hematological parameters
- Adequate Lung function reserve
Exclusion Criteria
- Previous chemotherapy and thoracic radiation for non small cell lung cancer
- Presence of distant metastases
Data sourced from ClinicalTrials.gov (NCT00192036). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.