Status:
COMPLETED
Concurrent Radiotherapy With Weekly Topotecan for Primary Treatment of Inoperable Localized Non-small Cell Lung Cancer
Lead Sponsor:
University of New Mexico
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 administer...
Detailed Description
This is a study of chemoradiation for patient with inoperable non small cell lung cancer with poor pulmonary function. These patients have usually very limited treatment options because of the comprom...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00322751
Start Date
April 1 2006
End Date
November 1 2009
Last Update
January 7 2010
Active Locations (1)
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1
University of New Mexico
Albuquerque, New Mexico, United States, 87131