Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT00945451
Brief Summary:
RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiosurgery after docetaxel and cisplatin may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and the best dose of stereotactic radiosurgery when given after docetaxel, cisplatin, and radiation therapy and to see how well it works in treating patients with stage III non-small cell lung cancer.
Detailed Description:
OBJECTIVES:
Primary
* Evaluate the maximum tolerated dose of stereotactic radiosurgery in patients with locally advanced non-small cell lung cancer undergoing concurrent chemoradiotherapy. (Phase I)
* Assess the response rate (complete and partial response) in these patients by RECIST criteria. (Phase II)
Secondary
* Determine the tolerability. (Phase I)
* Assess the quality of life of these patients by QLQ-C30 v3. (Phase I)
* Assess the overall and disease-free survival of these patients. (Phase II)
* Assess progression-free survival of these patients. (Phase II)
OUTLINE: This is a multicenter, phase I dose escalation study of stereotactic radiosurgery followed by a phase II study.
Patients receive docetaxel IV and cisplatin IV on days 1, 22, 43, 50, 57, and 64 in the absence of disease progression or unacceptable toxicity. Beginning on day 43, patients undergo concurrent radiotherapy to the mediastinum 5 days a week. Beginning 2-3 weeks after chemoradiotherapy, patients undergo stereotactic radiosurgery on days 1, 3, and 5.
Quality of life is assessed by the QLQ-C30 v3 questionnaire at baseline, after radiosurgery, and at 6 and 12 months after completion of study treatment.
After completion of study treatment, patients are followed up monthly for 6 months, every 3 months for 1 year, and then every 6 months for 3 years.
Study:
NCT00945451
Study Brief:
Protocol Section:
NCT00945451