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 range
18 Years – 120 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.