Lung Cancer
Conditions
Keywords
stage I non-small cell lung cancer, stage II non-small cell lung cancer
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.
Interventions
PROCEDUREcomputed tomography
Standard CT scans
RADIATIONfludeoxyglucose F 18
standard doses with CT scans
RADIATIONhypofractionated radiation therapy
4 doses over 2 weeks
RADIATIONstereotactic radiosurgery
CyberKnife radiosurgery
Sponsors
United States Department of Defense
Boston Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants to receive Cyberknife radiation therapy in 4 doses over two weeks. Dose will be determined using a dose-escalation plan.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants Who Did Not Experience a Dose Limiting Toxicity in the Less Than 3 Centimeter Cohort | 6 weeks | Number of Participants Who Did Not Experience a Dose Limiting Toxicity in the less than 3 centimeter cohort |
| Maximum Tolerated Dose in the Less Than 3 Centimeter Cohort | 6 weeks | The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early. |
| Participants Who Did Not Experience a Dose Limiting Toxicity in the More Than 3 Centimeter Cohort | 6 weeks | The number of participants that did not experience a dose-limiting toxicity in the greater than 3 centimeter cohort |
| Maximum Tolerated Dose - More Than 3 Centimeter Cohort. | 6 weeks | The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relationship Between Positron Emission Tomography (PET) Response and Local Control and Survival | 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 |
Countries
United States
Participant flow
Recruitment details
9 patients were enrolled onto this study between January 2009 and August 2012 in the Radiation Oncology Clinic at Boston Medical Center
Participants by arm
| Arm | Count |
|---|---|
| CyberKnife 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
Radiation: stereotactic radiosurgery CyberKnife radiosurgery | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | CyberKnife |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 | 0 / 0 | 0 / 3 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 3 / 3 | 3 / 3 | 0 / 0 | 3 / 3 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 1 / 3 | 2 / 3 | 0 / 0 | 1 / 3 | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: 6 weeks
Population: The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.
Primary
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.
Time frame: 6 weeks
Population: The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.
Primary
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
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 56 Gray (LESS Than 3 Centimeter Cohort) | Participants Who Did Not Experience a Dose Limiting Toxicity in the Less Than 3 Centimeter Cohort | 3 Participants |
| 62 Gray (LESS Less Than 3 Centimeter Cohort) | Participants Who Did Not Experience a Dose Limiting Toxicity in the Less Than 3 Centimeter Cohort | 3 Participants |
| 68 Gray (LESS Than 3 Centimeter Cohort) | Participants Who Did Not Experience a Dose Limiting Toxicity in the Less Than 3 Centimeter Cohort | 0 Participants |
Primary
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
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 56 Gray (LESS Than 3 Centimeter Cohort) | Participants Who Did Not Experience a Dose Limiting Toxicity in the More Than 3 Centimeter Cohort | 3 Participants |
| 62 Gray (LESS Less Than 3 Centimeter Cohort) | Participants Who Did Not Experience a Dose Limiting Toxicity in the More Than 3 Centimeter Cohort | 0 Participants |
| 68 Gray (LESS Than 3 Centimeter Cohort) | Participants Who Did Not Experience a Dose Limiting Toxicity in the More Than 3 Centimeter Cohort | 0 Participants |
Secondary
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
Time frame: before treatment and at 1, 3, 6, and 12 months after treatment
Population: Data were not collected and the outcome measure was not analyzed