Stereotactic Radiosurgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
Feasibility and Outcome of Cyberknife® Precision Hypofractionated Radiosurgery for the Curative Management of Non-Small Cell Lung Cancer
RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with stage I or stage II non-small cell lung cancer.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
OBJECTIVES:
- To establish the maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery in patients with medically inoperable, stage I or II non-small cell lung cancer.
- To establish the relationship between positron emission tomography (PET) response and local control and survival using fludeoxyglucose F 18 PET/CT imaging before treatment and at 1, 3, 6, and 12 months after treatment.
OUTLINE: Patients undergo placement of 3 gold fiducial markers by CT-guidance or bronchoscopy. Patients then undergo CyberKnife® hypofractionated stereotactic radiosurgery over 45-120 minutes twice weekly for 2 weeks.
Patients undergo fludeoxyglucose F 18 PET/CT scan at baseline and at 1, 3, 6, and 12 months after completion of treatment.
After completion of study treatment, patients are followed periodically for up to 4 years.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Massachusetts
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Boston, Massachusetts, Stati Uniti, 02118
- Boston University Cancer Research Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer
Stage I or II disease (T1-3, N0, M0)
- T2 or T3 tumor ≤ 5 cm
- No T3 tumors involving the central chest or mediastinum (only chest wall involvement allowed)
Tumor deemed technically resectable, in the opinion of an experienced thoracic surgeon, AND patient deemed "medically inoperable"
- Patients with fluorodeoxyglucose (FDG)-avidity in mediastinal lymph nodes are eligible provided they are able to undergo mediastinoscopy to confirm N0 status
PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
Exclusion Criteria:
- No history of contrast allergy
- No psychological issues that would preclude the completion of study treatment
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy or chemotherapy
- No suspected nodal metastasis that cannot be falsified by mediastinoscopy (i.e., hilar or mediastinal nodes that are either fludeoxyglucose F 18 [FDG]-avid or measure > 1 cm in short axis diameter on CT scan)
- No tumor within or touching the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (carina, right and left main stem bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 56 Gray (LESS than 3 centimeter cohort)
Intervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery |
Standard CT scans
standard doses with CT scans
4 doses over 2 weeks
CyberKnife radiosurgery
|
|
Sperimentale: 62 Gray (LESS than 3 centimeter cohort)
Intervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery |
Standard CT scans
standard doses with CT scans
4 doses over 2 weeks
CyberKnife radiosurgery
|
|
Sperimentale: 68 Gray (LESS than 3 centimeter cohort)
Intervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery |
Standard CT scans
standard doses with CT scans
4 doses over 2 weeks
CyberKnife radiosurgery
|
|
Sperimentale: 56 Gray (MORE than 3 centimeter cohort)
Intervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery |
Standard CT scans
standard doses with CT scans
4 doses over 2 weeks
CyberKnife radiosurgery
|
|
Sperimentale: 62 Gray (MORE than 3 centimeter cohort)
Intervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery |
Standard CT scans
standard doses with CT scans
4 doses over 2 weeks
CyberKnife radiosurgery
|
|
Sperimentale: 68 Gray (MORE than 3 centimeter cohort)
Intervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery |
Standard CT scans
standard doses with CT scans
4 doses over 2 weeks
CyberKnife radiosurgery
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Participants Who Did Not Experience a Dose Limiting Toxicity in the Less Than 3 Centimeter Cohort
Lasso di tempo: 6 weeks
|
Number of Participants Who Did Not Experience a Dose Limiting Toxicity in the less than 3 centimeter cohort
|
6 weeks
|
|
Maximum Tolerated Dose in the Less Than 3 Centimeter Cohort
Lasso di tempo: 6 weeks
|
The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.
|
6 weeks
|
|
Participants Who Did Not Experience a Dose Limiting Toxicity in the More Than 3 Centimeter Cohort
Lasso di tempo: 6 weeks
|
The number of participants that did not experience a dose-limiting toxicity in the greater than 3 centimeter cohort
|
6 weeks
|
|
Maximum Tolerated Dose - More Than 3 Centimeter Cohort.
Lasso di tempo: 6 weeks
|
The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.
|
6 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Relationship Between Positron Emission Tomography (PET) Response and Local Control and Survival
Lasso di tempo: before treatment and at 1, 3, 6, and 12 months after treatment
|
Relationship between positron emission tomography (PET) response and local control and survival as measured by fludeoxyglucose F 18 PET/CT imaging
|
before treatment and at 1, 3, 6, and 12 months after treatment
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Minh Tam Truong, MD, Boston Medical Center
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie delle vie respiratorie
- Neoplasie
- Malattie polmonari
- Neoplasie per sede
- Neoplasie delle vie respiratorie
- Neoplasie toraciche
- Carcinoma, broncogeno
- Neoplasie bronchiali
- Neoplasie polmonari
- Carcinoma, polmone non a piccole cellule
- Meccanismi molecolari dell'azione farmacologica
- Radiofarmaci
- Fluorodesossiglucosio F18
Altri numeri di identificazione dello studio
- H-26701
- CDR0000635119 (Altro numero di sovvenzione/finanziamento: Department of Defense)
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