Stereotactic Body Radiation Therapy (SBRT) for Lung Tumors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Florida Shands Cancer Center | Gainesville | Florida | United States | 32610 |
Sponsors and Collaborators
- University of Florida
Investigators
- Principal Investigator: Robert J Amdur, MD, University of Florida- Radiation Oncology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB # 502-2005
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | All Patients Receiving SBRT to Thorax |
|---|---|
| Arm/Group Description | 22 patients had Non-small-cell lung cancer (NSCLC), 6 had metastatic disease, and 6 had 2 lesions treated simultaneously. |
| Period Title: Overall Study | |
| STARTED | 38 |
| COMPLETED | 38 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | All Patients Receiving SBRT to Thorax |
|---|---|
| Arm/Group Description | 22 patients had Non-small-cell lung cancer (NSCLC), 6 had metastatic disease, and 6 had 2 lesions treated simultaneously. |
| Overall Participants | 38 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
8
21.1%
|
| >=65 years |
30
78.9%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
72.3
(9.8)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
25
65.8%
|
| Male |
13
34.2%
|
| Region of Enrollment (participants) [Number] | |
| United States |
38
100%
|
Outcome Measures
| Title | Disease Status |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | All Patients Receiving SBRT to the Thorax |
|---|---|
| Arm/Group Description | |
| Measure Participants | 38 |
| Rate of 2-year control |
84
221.1%
|
| Cause specific survival rate |
78
205.3%
|
| Overall Survival rate |
55
144.7%
|
| Freedom from Failure rate |
54
142.1%
|
| Title | Toxicity ot the Thorax |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | All Patients Receiving SBRT to the Thorax |
|---|---|
| Arm/Group Description | |
| Measure Participants | 38 |
| grade 2 toxicity |
30
78.9%
|
| grade 3 toxicity |
2
5.3%
|
| late grade 2 toxicity |
32
84.2%
|
| late grade 3 toxicity |
8
21.1%
|
Adverse Events
| Time Frame | 2 years, 9 months | |
|---|---|---|
| Adverse Event Reporting Description | Adverse events were assessed every 3 weeks for 3 months and then every 3 months. | |
| Arm/Group Title | All Patients Receiving SBRT to Thorax | |
| Arm/Group Description | 22 patients had Non-small-cell lung cancer (NSCLC), 6 had metastatic disease, and 6 had 2 lesions treated simultaneously. | |
All Cause Mortality |
||
| All Patients Receiving SBRT to Thorax | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| All Patients Receiving SBRT to Thorax | ||
| Affected / at Risk (%) | # Events | |
| Total | 20/38 (52.6%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Grade 3 Dyspnea | 9/38 (23.7%) | 24 |
| Grade 3 FEV1 | 17/38 (44.7%) | 33 |
| Grade 4 FEV1 | 2/38 (5.3%) | 3 |
| Grade 3 Vital Capacity | 6/38 (15.8%) | 11 |
| Skin and subcutaneous tissue disorders | ||
| Grade 3 Dermatitis | 1/38 (2.6%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| All Patients Receiving SBRT to Thorax | ||
| Affected / at Risk (%) | # Events | |
| Total | 38/38 (100%) | |
| Gastrointestinal disorders | ||
| Grade 1 Esophagitis | 1/38 (2.6%) | 1 |
| Grade 2 Esophagitis | 4/38 (10.5%) | 10 |
| Grade 1 Nausea | 16/38 (42.1%) | 22 |
| Grade 2 Nausea | 1/38 (2.6%) | 1 |
| Infections and infestations | ||
| Grade 1 Fever | 1/38 (2.6%) | 1 |
| Investigations | ||
| Grade 1 Fatigue | 29/38 (76.3%) | 133 |
| Grade 2 Fatigue | 13/38 (34.2%) | 29 |
| Respiratory, thoracic and mediastinal disorders | ||
| Grade 1 cough | 23/38 (60.5%) | 85 |
| Grade 2 Cough | 1/38 (2.6%) | 1 |
| Grade 1 Dyspnea | 17/38 (44.7%) | 77 |
| Grade 2 Dyspnea | 11/38 (28.9%) | 61 |
| Grade 1 FEV1 | 8/38 (21.1%) | 16 |
| Grade 2 FEV1 | 7/38 (18.4%) | 18 |
| Grade 1 Pleural Effusion | 3/38 (7.9%) | 8 |
| Grade 1 Pneumonitis | 10/38 (26.3%) | 19 |
| Grade 2 Pneumonitis | 3/38 (7.9%) | 3 |
| Grade 1 Pulmonary fibrosis | 10/38 (26.3%) | 22 |
| Grade 2 Pulmonary fibrosis | 2/38 (5.3%) | 2 |
| Grade 1 Vital Capacity | 9/38 (23.7%) | 16 |
| Grade 2 Vital Capacity | 21/38 (55.3%) | 43 |
| Skin and subcutaneous tissue disorders | ||
| Grade 1 Dermatitis | 21/38 (55.3%) | 41 |
| Grade 2 Dermatitis | 2/38 (5.3%) | 2 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Bridget Fitzgerald, Clinical Research Coordinator |
|---|---|
| Organization | University of Florida |
| Phone | 352-265-0680 ext 87829 |
| fitzgb@shands.ufl.edu |
- IRB # 502-2005