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The purpose of this trial is to test a deescalated 3-fraction stereotactic body radiotherapy (SBRT) regimen to 45 Gray (Gy) in 3 fractions for centrally located thoracic tumors.
The purpose of this trial is to test a deescalated 3-fraction SBRT regimen to 45 Gy in 3 fractions for centrally located thoracic tumors in a phase II trial. This will provide prospectively collected data on the safety and efficacy of a three-fraction regimen in the previously defined "No Fly Zone" for both primary non-small cell lung cancer (NSCLC) and for lung metastases of any histology. This registration describes the design and eligibility criteria for the 36 NSCLC subjects the investigators plan to enroll. Local control, cancer-specific survival, and overall survival results from the NSCLC patients will be compared to both 3- and 5-fraction historical controls, specifically RTOG 0236 and 0813 results.
The outcomes of the metastatic patients will also be reported.
There will also be a quality-of-life component to the study to assess the impact of a shorter overall treatment time and the clinical impact of radiation side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 45 Gy | Experimental | Deescalated 3-fraction stereotactic body radiotherapy regimen to 45 Gy in 3 fractions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 45 Gray (Gy) regimen | Radiation | Deescalated 3-fraction stereotactic body radiotherapy regimen to 45 Gy in 3 fractions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the stereotactic body radiotherapy regimen (SBRT) | Safety will be assessed by acute (defined as within 90 days of stereotactic body radiotherapy (SBRT)) and late (from 91 days through 2 years post-SBRT) toxicities. Toxicities are based on (Common Terminology Criteria for adverse events) CTCAE v. 5 criteria | From administration of SBRT up to 2 years post-SBRT |
| local control (LC) of 3-fraction stereotactic body radiotherapy | The absence of primary tumor failure. Primary tumor failure is defined as Increase in tumor dimension of 20%. | Up to 10 years post-enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| lobar control | Absence of primary tumor failure or involved lobe failure or both. | Up to 10 years post-enrollment. |
| regional control | Absence of measurable tumor within lymph nodes along the natural lymphatic drainage typical for the location of the treated primary disease only with dimension of at least 1.0 cm on imaging studies (preferably computer tomography scans) within the lung, bronchial hilum, or the mediastinum. |
| Measure | Description | Time Frame |
|---|---|---|
| organ at risk (OAR) dosimetry | Up to 10 years post-enrollment. | |
| quality of life (QOL) | QOL will be measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Each item of this 30-item questionnaire is measured on a scale ranging from 1-4, with higher scores signaling lower quality of life. The total possible score is 120. Quality of life will be measured longitudinally, as one outcome. This outcome will be measured at baseline, on the last day of treatment and at 1, 4, 8, and 12 months post-treatment. Thereafter, quality of life will be measured every 6 months, up to 5 years. |
Inclusion Criteria:
Exclusion Criteria:
Prior history of radiotherapy near target lesion resulting in overlapping treatment fields. Previously irradiated will be defined as OAR structures receiving the following doses (in <3Gy per fraction):
Active systemic, pulmonary, or pericardial infection
Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
Pregnant or lactating
Any other medical condition or reason that, in the opinion of the investigator, would preclude study participation
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Henry S. Park, MD, MPH | Contact | 203-200-2100 | henry.park@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Henry S. Park, MD, MPH | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Smilow Cancer Hospital Care Center at Greenwich | Recruiting | Greenwich | Connecticut | 06830 | United States |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D002985 | Clinical Protocols |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D016020 | Epidemiologic Study Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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The intervention group will be compared with historical controls.
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| Up to 10 years post-enrollment. |
| distant control | Up to 10 years post-enrollment. |
| overall survival | Up to 10 years post-enrollment. |
| progression-free survival | Up to 10 years post-enrollment. |
| baseline and up to 5 years. |
| Smilow Cancer Hospital Care Center - Guilford | Recruiting | Guilford | Connecticut | 06437 | United States |
|
| Smilow Cancer Hospital - Hamden Care Center | Recruiting | Hamden | Connecticut | 06518 | United States |
|
| Smilow Cancer Hospital | Recruiting | New Haven | Connecticut | 06511 | United States |
|
| Smilow Cancer Hospital Care Center - Trumbull | Recruiting | Trumbull | Connecticut | 06611 | United States |
|
| Smilow Cancer Hospital Care Center - Waterford | Recruiting | Waterford | Connecticut | 06385 | United States |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |