Clinical trial · Interventional
Concurrent Radiotherapy With Weekly Topotecan for Primary Treatment of Inoperable Localized Non-small Cell Lung Cancer
Phase I Study of Concurrent Radiotherapy With Weekly Topotecan for Primary Treatment of Inoperable Localized Non-small Cell Lung Cancer (NSCLC) (Stage I to IIIA)
NCT00322751CI-TRIAL-00002974completedPhase 1ClinicalTrials.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)
Given the activity of single-agent Topotecan in NSCLC, there is both scientific rationale and a medical interest in studying this agent in combination with radiation. In addition, Topotecan administered on a weekly basis offers advantages over the daily x 5 regimen, i.e., the convenience of administration and fewer visits to the clinic.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The primary endpoint is the establishment of the maximum tolerated dose (MTD) of topotecan given weekly with RT
- timeFrame
- Treatment with topotecan will last until RT is completed. Treatment will stop if there is disease progression or unacceptable toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically proven non-small cell lung cancer Stage I to IIIA. * Inoperable lung cancer because of poor respiratory lung function, or other medical reasons, as determined by the thoracic surgeon. * PS \< 2 * Age \> 18 years * Life expectancy of \> 12 weeks * Normal hematologic, liver, and renal function * No metastatic disease as determined by CT-PET scanning and bone scan. * No brain metastasis by MRI * No contraindication to radiotherapy Exclusion Criteria: * Patients with uncontrolled CNS metastases. * Active systemic infection. * Serious, uncontrolled intercurrent medical or psychiatric illness. * Secondary active primary malignancy. * Inability to comply with requirements of the study. * Any metastases outside of the mediastinum * Histologically positive pleural or pericardial effusion * Any chemotherapy within five years prior to enrollment on this protocol * Prior radiotherapy administered to the chest * Women who are pregnant or lactating * FEV1 \< 1 liter/minute
References
Publications (0)
Data not yet available
No reference posted for this study.