Status:
COMPLETED
Pulsed Paclitaxel And Daily Thoracic Radiotherapy For Inoperable (Stage I/II) Or Unresectable Lung Cancer
Lead Sponsor:
University of Rochester
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
A treatment study is being conducted by the University of Rochester Cancer Center (URCC) in which patients with non-small cell lung cancer will be treated with radiation therapy and a drug called pacl...
Eligibility Criteria
Inclusion
- Histologically confirmed lung cancer, excluding small cell carcinoma
- Inoperable stage I (T1-2N0) and II (T1-2N1, T3N0) disease, or stage IIIA (T3N1 andT1-3N2M0) and IIIB (TxN3M0, T4NxM0) diseases according to the American Joint Committee of Cancer criteria 1998
- The primary tumor must be radiographically measurable.
- Age \> 18.
- Karnofsky performance status \> 70.
- FEV1 sufficient for patients to tolerate radiation therapy which is at the discretion of the radiation oncologist, usually \> 800 ml
- Labs: WBC \> 3000; platelet count \> 100,000; serum creatinine \< 1.5 mg/dl or creatinine clearance \>60 ml/min.
- Laboratory values must be obtained \< 3 weeks prior to registration.
- A signed informed consent.
- Patients who failed prior chemotherapy are eligible. Patients with prior radiotherapy to the chest region are eligible as long as the normal tissue tolerance is not violated by repeat radiotherapy.
Exclusion
- Patients with medical contraindication to chemotherapy or radiotherapy.
- Patients with myocardial infarction within the preceding six months or symptomatic heart disease, including uncontrolled or unstable angina, uncontrolled congestive heart failure, and uncontrolled arrhythmia.
- Women who are pregnant.
- Patients with small cell carcinoma or mesothelioma
Key Trial Info
Start Date :
June 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00178256
Start Date
June 1 1998
End Date
December 1 2012
Last Update
August 21 2015
Active Locations (1)
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1
University of Rochester, Dept. Radiation Oncology
Rochester, New York, United States, 14642