- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00471835
Stereotactic Body Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
A Phase I/II Study of Hypofractionated Stereotactic Body Radiotherapy for Stage I/II Non-small Cell Lung Cancer Within the Central Lung Region and the Prognostic Impact of FDG Positron Emission Tomography
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic body radiation therapy and to see how well it works in treating patients with stage I or stage II non-small cell lung cancer.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of hypofractionated stereotactic body radiotherapy (SBRT) to the central lung region (peri-mediastinum) in patients with stage I or II non-small cell lung cancer. (Phase I)
- Determine local control and time to local progression in patients treated with this regimen. (Phase II)
- Evaluate the ability of peak standardized uptake values (SUV) for fludeoxyglucose F 18 (FDG)-PET scan, obtained shortly after SBRT (post-treatment), to predict local control and time to progression in these patients.
Secondary
- Evaluate the ability of maximum SUV for FDG-PET scan, obtained shortly after SBRT, to predict long-term local control and time to progression in these patients.
- Evaluate the ability of peak SUV and max SUV for FDG-PET scan, obtained prior to SBRT, to predict local control and time to progression in these patients.
- Determine the utility of PET/CT scan data in guiding treatment planning.
- Determine if treatment with radiotherapy involving high biological doses with limited treatment volume using these SBRT techniques achieves acceptable treatment-related toxicity.
OUTLINE: This is a phase I dose-escalation study followed by a phase II open-label study.
- Phase I: Patients undergo hypofractionated stereotactic body radiotherapy (SBRT) 3 times within a 2-week time frame.
Cohorts of 3-6 patients receive escalating doses of hypofractionated SBRT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Phase II: Patients undergo hypofractionated SBRT at the MTD as in phase I. In both phases, patients undergo fludeoxyglucose F 18-PET/CT scans at baseline and at 12-16 weeks after completion of SBRT.
After completion of study treatment, patients are followed periodically for 4 years.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.
Studietyp
Fas
- Fas 2
- Fas 1
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed stage I or II non-small cell lung cancer meeting the following criteria:
- No bronchoalveolar cell carcinoma
Maximum T2 or T3 tumor size ≤ 5 cm
- T3 primary tumor must be limited to chest wall
Primary tumor of any T stage must be within or touching the zone of the trachea or proximal bronchial tree, defined as a volume of 2 cm in all directions around the trachea and proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchi, right middle lobe bronchus, right and left lower lobe bronchi)
- For lesions inferior to the proximal bronchial tree, the primary tumor must be within 2 cm of the esophagus
- Patients with N1 (hilar) lymph nodes positive for malignancy based on size, fludeoxyglucose F 18 (FDG)-PET scan uptake, or biopsy are eligible if the N1 lymph nodes are located such that they are contiguously within the same stereotactic radiation treatment field as the primary tumor
Mediastinal lymph nodes must be ≤ 1 cm and no abnormal uptake on FDG-PET scan in those areas
- Patients with > 1 cm lymph nodes or abnormal FDG-PET scan (including suspicious but non-diagnostic uptake) are eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer
No evidence of distant metastases
Suspected M1 disease based on pre-treatment PET imaging must be biopsied
- If the biopsy is positive, the patient is ineligible
- If the biopsy is negative and representative of the lesion in question, the patient is eligible
If the biopsy is non-diagnostic, consideration should be given to repeat biopsy
- If the repeat biopsy remains non-diagnostic or a biopsy is not feasible, then the patient is ineligible
Technically resectable disease
- Surgery refused or patient deemed medically inoperable due to co-morbid conditions
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-2
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No synchronous primary or invasive malignancy within the past 2 years other than non-melanomatous skin cancer
- No active systemic, pulmonary, or pericardial infection
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chest radiotherapy (lung or mediastinum)
- No other concurrent anticancer therapy, including other radiotherapy, radiofrequency ablation (or other antineoplastic interventional radiology techniques), chemotherapy, biological therapy, vaccine therapy, or surgery
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Maskning: Ingen (Open Label)
Vad mäter studien?
Primära resultatmått
Resultatmått |
---|
Maximal tolererad dos (fas I)
|
Time to progression and local control at 1 and 2 years (Phase II)
|
Sekundära resultatmått
Resultatmått |
---|
Giftighet
|
Rate of acute and late treatment-related toxicity related to specific symptoms, including gastrointestinal, cardiac, neurologic, hemorrhagic, and pulmonary symptoms
|
Patterns of failure and overall survival at 2 years
|
Measurement of pre-treatment and post-treatment PET scan standardized uptake values and correlation of this data with local control at 1 and 2 years
|
Samarbetspartners och utredare
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CCCWFU-62206
- CDR0000543743 (Registeridentifierare: PDQ (Physician Data Query))
- CCCWFU-IRB00000578
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