Clinical trial NCT00852644: Stereotactic Radiosurgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
Official title: Feasibility and Outcome of Cyberknife® Precision Hypofractionated Radiosurgery for the Curative Management of Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Cancer
Keywords: stage I non-small cell lung cancer
stage II non-small cell lung cancer
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2009-02-27
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Participants to receive Cyberknife radiation therapy in 4 doses over two weeks. Dose will be determined using a dose-escalation plan.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Participants Who Did Not Experience a Dose Limiting Toxicity in the Less Than 3 Centimeter Cohort
timeFrame: 6 weeks
measure: Maximum Tolerated Dose in the Less Than 3 Centimeter Cohort
timeFrame: 6 weeks
measure: Participants Who Did Not Experience a Dose Limiting Toxicity in the More Than 3 Centimeter Cohort
timeFrame: 6 weeks
measure: Maximum Tolerated Dose - More Than 3 Centimeter Cohort.
timeFrame: 6 weeks
Secondary outcomes:
measure: Relationship Between Positron Emission Tomography (PET) Response and Local Control and Survival
timeFrame: before treatment and at 1, 3, 6, and 12 months after treatment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University Cancer Research Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Minh Tam Truong, MD
role: PRINCIPAL_INVESTIGATOR
References: