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| ID | Type | Description | Link |
|---|---|---|---|
| CALACASS-CYBERTAXCIS | |||
| INCA-RECF0941 | |||
| 2008-A01104-51 |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CyberKnife irradiation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CK | Device | Cyberknife Irradiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (phase I) | 5 years | |
| Overall response rate by RECIST (phase II) | 5 years |
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DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer
No metastatic disease
Unable to undergo surgery after concurrent chemoradiotherapy
Must have 1-3 tumor target masses < 5 cm in greatest diameter and separated by ≥ 2 cm after concurrent chemoradiotherapy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre-Yves Bondiau, MD, PhD | Centre Antoine Lacassagne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Antoine Lacassagne | Nice | 06189 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29650404 | Result | Doyen J, Poudenx M, Gal J, Otto J, Guerder C, Naghavi AO, Gerard A, Leysalle A, Cohen C, Padovani B, Ianessi A, Schiappa R, Chamorey E, Bondiau PY. Stereotactic ablative radiotherapy after concomitant chemoradiotherapy in non-small cell lung cancer: A TITE-CRM phase 1 trial. Radiother Oncol. 2018 May;127(2):239-245. doi: 10.1016/j.radonc.2018.03.024. Epub 2018 Apr 9. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |