Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Memorial Hospital of Rhode Island | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy and toxicity stereotactic body radiation (SBRT) as consolidation following standard chemoradiation for patients with stage III non-small cell lung cancer.
This protocol will investigate the potential role of SBRT for patients with stage 3 NSCLC. Eligible patients will first have received standard 50.4 Gy chemoradiation. Patients entering the study will have the opportunity to receive SBRT as a noninvasive option as compared to surgical resection. For patients who are not surgical candidates, SBRT after 50.4 Gy chemoradiation represents a technique of radiation consolidation that may be more effective and less toxic than standard conventional fractionated radiation
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic radiation Arm 1 | Experimental | Dose Levels/total Dose 1 16 Gy |
|
| Stereotactic radiation Arm 2 | Experimental | 2 20 Gy |
|
| Stereotactic radiation Arm 3 | Experimental | 3 24 Gy |
|
| Stereotactic radiation Arm 4 | Experimental | 4 28 Gy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic radiation Arm 1 | Radiation | Dose Levels Dose per Fraction Total Dose 1 8 Gy 16 Gy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Early and Intermediate Toxicity for Dose Limiting Toxicity | Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Serious adverse events will be captured from the time the patient signs consent until 12 weeks after the last SBRT. DLTS: defined in protocol as: Dose limiting toxicities will be defined as grade 3 or greater treatment related pneumonitis, cardiac toxicity, bronchial injury or chest wall pain during or within 4 weeks of completion of SBRT. | 3 months |
Not provided
Not provided
PATIENT ELIGIBILITY Conditions for Patient Eligibility (Inclusion)
Pathologically or cytologically confirmed NSCLC
Stage III NSCLC according to the AJCC 7th edition staging criteria. Stage II (T1-3N1) patient that are deemed medically inoperable are also eligible.
Concurrent chemoradiation to a radiation dose of 50.4 Gy.
residual tumor volume after concurrent chemoradiation that is appropriate for SBRT:
Absolute neutrophil count ≥ 1,000/uL, platelet ≥ 60,000/uL.
Total bilirubin ≤ 2x upper institutional limit of normal (ULN), and AST or ALT ≤5x ULN.
ECOG performance status 0 to 2
Minimum life expectancy of 12 weeks.
Age older than 18 years.
Voluntary, signed written informed consent.
Women of childbearing potential must have a negative pregnancy test
Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 1 months thereafter.
Conditions for Patient Ineligibility (Exclusion)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Howard Safran, MD | BrUOG Study Chair | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| memorial Hospital of Rhode island | Pawtucket | Rhode Island | 02860 | United States | ||
| Rhode Island Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Stereotactic Radiation Dose Level 1 | Radiation: Stereotactic radiation Arm 1 Dose Levels Dose per Fraction Total Dose 1 8 Gy 16 Gy |
| FG001 | Stereotactic Radiation Dose Level 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Stereotactic radiation Arm 2 | Radiation | Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy |
|
| Stereotactic radiation Arm 3 | Radiation | Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy |
|
| Stereotactic radiation Arm 4 | Radiation | Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy |
|
| Providence |
| Rhode Island |
| 02903 |
| United States |
Radiation: Stereotactic radiation Arm 2 Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy
| FG002 | Stereotactic Radiation Dose Level 3 | Radiation: Stereotactic radiation Arm 3 Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy |
| FG003 | Stereotactic Radiation Dose Level 4 | Radiation: Stereotactic radiation Arm 4 Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Stereotactic Radiation | stereotactic |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Early and Intermediate Toxicity for Dose Limiting Toxicity | Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Serious adverse events will be captured from the time the patient signs consent until 12 weeks after the last SBRT. DLTS: defined in protocol as: Dose limiting toxicities will be defined as grade 3 or greater treatment related pneumonitis, cardiac toxicity, bronchial injury or chest wall pain during or within 4 weeks of completion of SBRT. | Posted | Number | participants | 3 months |
|
|
|
Baseline, 30 days post last dose of SBRT, 12 weeks post last dose of SBRT
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1-Stereotactic Radiation Dose Level 1 | Radiation: Stereotactic radiation Arm 1 Dose Levels Dose per Fraction Total Dose 1 8 Gy 16 Gy | 1 | 3 | 3 | 3 | ||
| EG001 | Arm 2-Stereotactic Radiation Dose Level 2 | Radiation: Stereotactic radiation Arm 2 Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy | 0 | 3 | 2 | 3 | ||
| EG002 | Arm 3-Stereotactic Radiation Dose Level 3 | Radiation: Stereotactic radiation Arm 3 Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy | 1 | 3 | 3 | 3 | ||
| EG003 | Arm 4-Stereotactic Radiation Dose Level 4 | Radiation: Stereotactic radiation Arm 4 Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy | 2 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| K(3), AKI secondary to cisplatin nephrotoxicity(5) | Investigations | Systematic Assessment | not related to study |
| |
| AKI(2*) RT poor intake, CR(2*) RT poor intake, Fatigue (2*) RT pneumonia or chemo, H/A(2*) related | Investigations | Systematic Assessment |
| ||
| hypoglycemia(2*), chest pain (3*), Hyperglycemia(3*), HGB(2*), CR(1*) k(1*) | Investigations | Systematic Assessment | ALL events unrelated to SBRT and related to patients underlying medical history |
| |
| Dyspnea 4*, Tachycardia 2*, Fever 1*cough 1*- | Investigations | Systematic Assessment | all unlikely related to SBRT |
| |
| Bronchopulmonary Hemorrhage (5) | Investigations | Systematic Assessment | likely related to SBRT as late toxicity |
| |
| upper respiratory infection | Investigations | Systematic Assessment | NOT r/t SBRT.Pt #13: fever(3),AKI(1),dyspnea(3),URI(3),Lung Infection Influenza A(3), Productive cough(1) F/u: MG(3),PLT(1),AKI(1),CR(1),nausea(1),dizziness(1), leukocytosis(3),hypoxia, URI (3) F/U #2 pneumonia(3*)&influzena (3*) |
| |
| URI (3*) rt chemo, PLT(2*) PR chemo, hyponatremia (3*) PR chemo, bilateral thigh pain(2*) suspected | Investigations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HgB | Investigations | Systematic Assessment |
| ||
| vomiting | Investigations | Systematic Assessment |
| ||
| Creatinine | Investigations | Systematic Assessment |
| ||
| WBC | Investigations | Systematic Assessment |
| ||
| Thrombocytopenia | Investigations | Systematic Assessment |
| ||
| dermatitis | Investigations | Systematic Assessment |
| ||
| pleural effusion | Investigations | Systematic Assessment |
| ||
| Lymph | Investigations | Systematic Assessment |
| ||
| Bili | Investigations | Systematic Assessment |
| ||
| dyspnea/hypoxia | Investigations | Systematic Assessment |
| ||
| myalgia | Investigations | Systematic Assessment |
| ||
| esophagitis | Investigations | Systematic Assessment |
| ||
| K | Investigations | Systematic Assessment |
| ||
| ANC | Investigations | Systematic Assessment |
| ||
| cough | Investigations | Systematic Assessment |
| ||
| fatigue | Investigations | Systematic Assessment |
| ||
| pain- thigh/leg/groin/chest wall | Investigations | Systematic Assessment |
| ||
| nausea | Investigations | Systematic Assessment |
| ||
| Ca | Investigations | Systematic Assessment |
| ||
| pneumonitis ,upper respiratory infection (URI),lung Infection (influenza A) | Investigations | Systematic Assessment |
| ||
| AST | Investigations | Systematic Assessment |
| ||
| ALT | Investigations | Systematic Assessment |
| ||
| Magnesium | Investigations | Systematic Assessment |
| ||
| fever | Investigations | Systematic Assessment |
| ||
| diarrhea | Investigations | Systematic Assessment |
| ||
| chills | Investigations | Systematic Assessment |
| ||
| edema | Investigations | Systematic Assessment |
| ||
| aspiration | Investigations | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas DiPetrillo, MD | Brown University Oncology Research Group (BrUOG) | 4018633000 | kayla_rosati@brown.edu |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided