Lung Cancer
Conditions
Brief summary
The purpose of this research study is to determine if Stereotactic Body Radiation Therapy(SBRT) is a good way to treat tumors near the thorax. Stereotactic Body Radiation Therapy (SBRT) is a general term for a group of techniques that are designed to deliver radiation therapy in a way that damages normal tissues less than conventional radiotherapy. The two features that distinguish SBRT from conventional therapy are procedures that decrease errors in patient positioning and technology that results in a radiation dose distribution that conforms more tightly to the tumor target. Patients will receive either 48 Gy or 60 Gy fractions depending on the type of tumor. The majority of patients will be treated in 1 week, Monday through Friday, with Wednesday off.
Detailed description
Stereotactic Body Radiotherapy (SBRT) for tumors in the thorax is a relatively new therapy in the United States, but has been used extensively in Japan for more than 10 years. This protocol seeks to enroll patients in three broad categories based on histology and clinical scenario: primary therapy for non-small-cell lung cancer (NSCLC), primary therapy to thoracic metastases, and retreatment of previously irradiated tumors or lung. Primary lung tumors Several studies have been published describing the utility of Stereotactic Body Radiotherapy (SBRT) for primary untreated lung tumors. In the United States, the most influential has been the experience of Robert Timmerman at the University of Indiana (7). They enrolled 37 patients in a dose escalation trial of SBRT for T1 N0 and T2 N0 patients with Non-small-cell lung cancer (NSCLC). The trial began with 24 Gy given in 3 fractions and escalated to 60 Gy given in 3 fractions. Dose limited toxicity (DLT) was defined as any grade 3 pulmonary, esophageal, cardiac, or pericardial toxicity, or any grade 4 toxicity that was ascribed to the protocol treatment using the Common Toxicity Criteria from the National Cancer Institute. The maximum tolerated dose (MTD) was defined at dose where less and 2 of 5 enrolled patients experienced DLT. The MTD was not determined by this trial as this criteria was not met in the enrolled patients. Of the 37 patients, 2 experienced Grade 3 toxicity. One patient experienced pneumonitis and other patient experienced hypoxemia. Both patients responded to therapy and made full recoveries. There were no long term complications reported from the treatment at a mean follow-up of 15 months.
Interventions
RADIATIONStereotactic Body Radiation Therapy
Prescription dose: 48 Gy or 60 Gy RT
Sponsors
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Informed consent to participate in this protocol * Patients of all ages are eligible * All tumor types are eligible * Patients with prior thoracic radiotherapy and/or surgery are eligible * Tumor size ≤ 5 cm
Exclusion criteria
* The subject is eligible for surgical resection or prefers treatment on this protocol to surgical resection. * Less than 1 year since original radiation to thorax for retreatment patients. * More than 2 tumors requiring SBRT * The patient cannot be positioned reproducibly due to pain or other factors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Status | 2 yrs | 2-year local control (Percentage of tumors that did not recur at treated site 2 years after treatment), cause-specific survival (percentage of patients who had not died from disease under study in the 2 years since treatment), overall survival (percent of patients still alive at 2 years after treatment), and freedom from failure (percentage of patients in whom the disease treated had not progressed or recurred in the 2 years since treatment) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity ot the Thorax | up to 2 years, 9 months | Toxicity is defined as adverse events described in the CTCAE (version 3). Acute toxicity refers to adverse events that occurred up until 3 months after treatment and late toxicity as those occurring 3 months or longer after the end of treatment. Below are the Rates of grade 2 acute toxicity, grade 3 acute toxicity, late grade 3 toxicity, and late grade 4 toxicity |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Patients Receiving SBRT to Thorax 22 patients had Non-small-cell lung cancer (NSCLC), 6 had metastatic disease, and 6 had 2 lesions treated simultaneously. | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | All Patients Receiving SBRT to Thorax |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 30 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age Continuous | 72.3 years STANDARD_DEVIATION 9.8 |
| Region of Enrollment United States | 38 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 38 / 38 |
| serious Total, serious adverse events | 20 / 38 |
Outcome results
Primary
Disease Status
2-year local control (Percentage of tumors that did not recur at treated site 2 years after treatment), cause-specific survival (percentage of patients who had not died from disease under study in the 2 years since treatment), overall survival (percent of patients still alive at 2 years after treatment), and freedom from failure (percentage of patients in whom the disease treated had not progressed or recurred in the 2 years since treatment)
Time frame: 2 yrs
Population: 44 lesions in 38 patients were treated with IMRT or 3D conformal beams on a prospective trial examining thoracic SBRT. Twenty-two of 32 primary lung cancer patients had biopsy-proven NSCLC (stage IA, 21 patients; stage IB, 11 patients). Six had metastatic disease. Six patients had 2 lesions treated simultaneously.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Patients Receiving SBRT to the Thorax | Disease Status | Rate of 2-year control | 84 percentage of participants |
| All Patients Receiving SBRT to the Thorax | Disease Status | Cause specific survival rate | 78 percentage of participants |
| All Patients Receiving SBRT to the Thorax | Disease Status | Overall Survival rate | 55 percentage of participants |
| All Patients Receiving SBRT to the Thorax | Disease Status | Freedom from Failure rate | 54 percentage of participants |
Secondary
Toxicity ot the Thorax
Toxicity is defined as adverse events described in the CTCAE (version 3). Acute toxicity refers to adverse events that occurred up until 3 months after treatment and late toxicity as those occurring 3 months or longer after the end of treatment. Below are the Rates of grade 2 acute toxicity, grade 3 acute toxicity, late grade 3 toxicity, and late grade 4 toxicity
Time frame: up to 2 years, 9 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Patients Receiving SBRT to the Thorax | Toxicity ot the Thorax | grade 2 toxicity | 30 percentage of participants |
| All Patients Receiving SBRT to the Thorax | Toxicity ot the Thorax | grade 3 toxicity | 2 percentage of participants |
| All Patients Receiving SBRT to the Thorax | Toxicity ot the Thorax | late grade 2 toxicity | 32 percentage of participants |
| All Patients Receiving SBRT to the Thorax | Toxicity ot the Thorax | late grade 3 toxicity | 8 percentage of participants |