Stereotactic Radiosurgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Feasibility and Outcome of Cyberknife® Precision Hypofractionated Radiosurgery for the Curative Management of Non-Small Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Procedure: computed tomography
* Radiation: fludeoxyglucose F 18
* Radiation: hypofractionated radiation therapy
* Radiation: stereotactic radiosurgery


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Participants to receive Cyberknife radiation therapy in 4 doses over two weeks. Dose will be determined using a dose-escalation plan.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 56 Gray (LESS than 3 centimeter cohort)<br>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 | Procedure: computed tomography<br>* Standard CT scans<br>Radiation: fludeoxyglucose F 18<br>* standard doses with CT scans<br>Radiation: hypofractionated radiation therapy<br>* 4 doses over 2 weeks<br>Radiation: stereotactic radiosurgery<br>* CyberKnife radiosurgery<br>|
| Experimental: 62 Gray (LESS than 3 centimeter cohort)<br>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 | Procedure: computed tomography<br>* Standard CT scans<br>Radiation: fludeoxyglucose F 18<br>* standard doses with CT scans<br>Radiation: hypofractionated radiation therapy<br>* 4 doses over 2 weeks<br>Radiation: stereotactic radiosurgery<br>* CyberKnife radiosurgery<br>|
| Experimental: 68 Gray (LESS than 3 centimeter cohort)<br>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 | Procedure: computed tomography<br>* Standard CT scans<br>Radiation: fludeoxyglucose F 18<br>* standard doses with CT scans<br>Radiation: hypofractionated radiation therapy<br>* 4 doses over 2 weeks<br>Radiation: stereotactic radiosurgery<br>* CyberKnife radiosurgery<br>|
| Experimental: 56 Gray (MORE than 3 centimeter cohort)<br>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 | Procedure: computed tomography<br>* Standard CT scans<br>Radiation: fludeoxyglucose F 18<br>* standard doses with CT scans<br>Radiation: hypofractionated radiation therapy<br>* 4 doses over 2 weeks<br>Radiation: stereotactic radiosurgery<br>* CyberKnife radiosurgery<br>|
| Experimental: 62 Gray (MORE than 3 centimeter cohort)<br>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 | Procedure: computed tomography<br>* Standard CT scans<br>Radiation: fludeoxyglucose F 18<br>* standard doses with CT scans<br>Radiation: hypofractionated radiation therapy<br>* 4 doses over 2 weeks<br>Radiation: stereotactic radiosurgery<br>* CyberKnife radiosurgery<br>|
| Experimental: 68 Gray (MORE than 3 centimeter cohort)<br>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 | Procedure: computed tomography<br>* Standard CT scans<br>Radiation: fludeoxyglucose F 18<br>* standard doses with CT scans<br>Radiation: hypofractionated radiation therapy<br>* 4 doses over 2 weeks<br>Radiation: stereotactic radiosurgery<br>* CyberKnife radiosurgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants Who Did Not Experience a Dose Limiting Toxicity in the Less Than 3 Centimeter Cohort | 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 | 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 | 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. | The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship Between Positron Emission Tomography (PET) Response and Local Control and Survival | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I non-small cell lung cancer, stage II non-small cell lung cancer