Trials / Terminated
TerminatedNCT01411098
Radiation Therapy, Cisplatin, and Etoposide in Treating Patients With Non-small Cell Lung Cancer That Cannot Be Removed by Surgery
A Phase I Dose-Intensification Study Using Radiation Therapy and Concurrent Cisplatin and Etoposide for Patients With Inoperable Non-small Cell Lung Cancer
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- University of Washington · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This phase I trial studies the side effects and best dose of radiation therapy when given together with cisplatin and etoposide in treating patients with non-small cell lung cancer that cannot be removed by surgery. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Drugs, such as cisplatin, may make tumor cells more sensitive to radiation therapy. Giving radiation therapy together with cisplatin and etoposide may kill more tumor cells.
Detailed description
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of escalating doses of radiotherapy (RT) administered concomitantly with a fixed dose of cisplatin and etoposide within the same overall treatment time. OUTLINE: This is a dose-escalation study of radiation therapy. Patients undergo 3-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) 5 days a week for 8 weeks. Patients also receive cisplatin intravenously (IV) over 60 minutes on days 1, 8, 28, and 36 and etoposide IV over 60 minutes on days 1-5 and 28-32. After completion of study treatment, patients are followed up at 8 weeks and 6 months.
Conditions
- Recurrent Non-small Cell Lung Cancer
- Stage IIB Non-small Cell Lung Cancer
- Stage IIIA Non-small Cell Lung Cancer
- Stage IIIB Non-small Cell Lung Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | 3-dimensional conformal radiation therapy | Undergo 3D-CRT |
| RADIATION | intensity-modulated radiation therapy | Undergo IMRT |
| DRUG | cisplatin | Given IV |
| DRUG | etoposide | Given IV |
Timeline
- Start date
- 2011-10-01
- Primary completion
- 2015-03-01
- First posted
- 2011-08-08
- Last updated
- 2015-11-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01411098. Inclusion in this directory is not an endorsement.