Status:
COMPLETED
Stereotactic Radiosurgery in Treating Patients Undergoing Chemotherapy and Radiation Therapy For Stage III Non-Small Cell Lung Cancer
Lead Sponsor:
Centre Antoine Lacassagne
Conditions:
Lung Cancer
Eligibility:
All Genders
18-120 years
Phase:
NA
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. Stereot...
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)...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 24 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2016
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00945451
Start Date
April 24 2009
End Date
November 17 2016
Last Update
September 16 2019
Active Locations (1)
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1
Centre Antoine Lacassagne
Nice, France, 06189