Study of Doses Escalation on Efficacy on Cyberknife After Docetaxel-Cisplatin Concomitant Radiotherapy for Non Small Cells Lung Cancer Stage III
18 Years
N/A
Both
Lung Cancer
Trial Information
Study of Doses Escalation on Efficacy on Cyberknife After Docetaxel-Cisplatin Concomitant Radiotherapy for Non Small Cells Lung Cancer Stage III
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)
- Assess the response rate (complete and partial response) in these patients by RECIST
criteria. (Phase II)
Secondary
- 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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose (phase I)
Safety Issue:
Yes
Principal Investigator
Pierre-Yves Bondiau, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Centre Antoine Lacassagne
Authority:
Unspecified
Study ID:
CDR0000639362
NCT ID:
NCT00945451
Start Date:
January 2009
Completion Date:
Related Keywords:
- Lung Cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- stage II non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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