Study of Doses Escalation on Efficacy on Cyberknife After Docetaxel-Cisplatin Concomitant Radiotherapy for Non Small Cells Lung Cancer Stage III
- Evaluate the maximum tolerated dose of stereotactic radiosurgery in patients with
locally advanced non-small cell lung cancer undergoing concurrent chemoradiotherapy.
- Assess the response rate (complete and partial response) in these patients by RECIST
criteria. (Phase II)
- 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.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (phase I)
Pierre-Yves Bondiau, MD, PhD
Centre Antoine Lacassagne