Stereotactic Radiosurgery in Treating Patients Undergoing Chemotherapy and Radiation Therapy For … (NCT00945451) | Clinical Trial Compass
CompletedNot Applicable
Stereotactic Radiosurgery in Treating Patients Undergoing Chemotherapy and Radiation Therapy For Stage III Non-Small Cell Lung Cancer
France35 participantsStarted 2009-04-24
Plain-language 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.
Who can participate
Age range18 Years – 120 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed non-small cell lung cancer
* Locally advanced disease
* 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:
* WHO performance status 0-2
* Platelet count \> 100,000/mm³
* Hemoglobin \> 9 g/dL
* Neutrophil \> 1.0 x 10\^9/L
* FEV\_1 \> 30% of vital capacity
* Vital capacity \> 25% of predicted value
* DLCO \> 25% of predicted value
* LVEF ≥ 35%
* PT \> 80
* aPTT \> 35 sec
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after completion of study treatment
* Not under guardianship
* No dyspnea related to NYHA class III-IV heart failure
* No indirect signs of pulmonary arterial hypertension (pulmonary arterial systolic BP \> 45 mm Hg)
* No pulmonary acceleration time \< 100 ms
* No contraindication to fiducial insertion
* No geographical, social, or psychological conditions that would interfere with medical follow-up
PRIOR CONCURRENT THERAPY:
* Docetaxel and platinum-based drugs with concurrent irradiation allowed
* No prior surgery or surgery after the first phase of treatment with concurrent chemoradiotherapy
* No prior irradiation to lung
* No concurrent participation in another study trial