Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-02943 | Registry Identifier | NCI CTRP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the response of lung tumors to radiation therapy. This study will be using a type of radiation therapy called tomotherapy. Tomotherapy is a relatively new kind of therapy which is able to focus a large amount of radiation to a small area with relatively less radiation to the surrounding non-cancerous part of the organ. This study is being done to find out if this technique is able to control the cancer better or not than the standard radiation and also to study its safety.
The introduction of stereotactic body radiation therapy (SBRT) has allowed safe dose escalation in treatment regimens for cancer. Several studies have shown a radiation dose-response relationship for survival and local control for tumors of the lung, including cancer that originates in the lung (such as non-small cell lung cancer) as well as cancer that metastasizes to the lung.
The purpose of this study is to determine the response rate and toxicity of SBRT treatment of patients with lung tumors. This study will use a dose of 60 gray (Gy) in 5 fractions of 12 Gy. This provides a biological equivalent dose with alpha/beta ratio of 10 (BED10) of 132 Gy with the anticipation of achieving local control without increased toxicity. Previous studies have shown that the response rate with SBRT across multiple studies is approximately 50%, with an additional 25-40% of patients having stable disease. We hypothesize that this regimen will achieve a response rate of 70% with grade 3 toxicity of less than 5%.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Body Radiation (SBRT) | Experimental | 60 Gy using 12 Gy per fraction over 5 fractions, to be given within 10 calendar days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiation | Radiation | A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the planning target volume. Dose homogeneity +/- 5%. |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate (RR): | RR is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. RR is the sum of the percentage of patients who achieved a CR or PR. (RR = CR + PR) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Related Toxicity | Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Frequency and severity of adverse events will be tabulated and reported. | 2 years |
| Overall Survival (OS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ben Liem, M.D | University of New Mexico Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universtiy of New Mexico Comprehensive Cancer Center | Albuquerque | New Mexico | 87131-0001 | United States |
Not provided
| Label | URL |
|---|---|
| New Mexico Cancer Care Alliance | View source |
| University of New Mexico Cancer Center | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Stereotactic Body Radiation (SBRT) | 60 Gy using 12 Gy per fraction over 5 fractions, to be given within 10 calendar days Stereotactic Body Radiation: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the planning target volume. Dose homogeneity +/- 5%. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 60 Gy Using 12 Gy Per Fraction Over 5 Fractions | Radiation dose of 60 Gy administered in 5 fractions of 12 Gy each. |
| 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 |
| 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 | Response Rate (RR): | RR is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. RR is the sum of the percentage of patients who achieved a CR or PR. (RR = CR + PR) | Posted | Count of Units | tumors | 2 years | tumors | tumors |
|
6 years, 9 months
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 | Stereotactic Body Radiation (SBRT) | 60 Gy using 12 Gy per fraction over 5 fractions, to be given within 10 calendar days Stereotactic Body Radiation: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the planning target volume. Dose homogeneity +/- 5%. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agitation | Psychiatric disorders | NCI v3.0 |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ben Liem, MD | University of New Mexico Comprehensive Cancer Center | 505-272-0086 | BLiem@salud.unm.edu |
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
The time from treatment initiation to death by any cause |
| up to 67 months |
| Progression Free Survival (PFS) | The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | 2 years |
| Clinical Benefit Rate (CBR) | CBR is evaluated according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Complete response (CR): Disappearance of all evidence of target and non-target lesions. Partial response (P): >= 30% reduction from baseline in the sum of the longest diameter of all lesions. Stable Disease (SD): Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. CBR is the sum of the percentage of patients who achieve a CR, PR or SD (CBR = CR + PR + SD). | 2 years |
| other complicating condition |
|
| Physician Decision |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Treatment Related Toxicity | Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Frequency and severity of adverse events will be tabulated and reported. | Posted | Number | participants | 2 years |
|
|
|
| Secondary | Overall Survival (OS) | The time from treatment initiation to death by any cause | Posted | Median | 95% Confidence Interval | months | up to 67 months |
|
|
|
| Secondary | Progression Free Survival (PFS) | The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Secondary | Clinical Benefit Rate (CBR) | CBR is evaluated according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Complete response (CR): Disappearance of all evidence of target and non-target lesions. Partial response (P): >= 30% reduction from baseline in the sum of the longest diameter of all lesions. Stable Disease (SD): Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. CBR is the sum of the percentage of patients who achieve a CR, PR or SD (CBR = CR + PR + SD). | Posted | Count of Units | tumors | 2 years | tumors | tumors |
|
|
|
| 0 |
| 44 |
| 7 |
| 44 |
| Chest pain | Cardiac disorders | NCI v3.0 |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | NCI v3.0 |
|
| Fatigue | General disorders | NCI v3.0 |
|
| Fever | General disorders | NCI v3.0 |
|
| Muscle weakness upper limb | Musculoskeletal and connective tissue disorders | NCI v3.0 |
|
| Myalgia | Musculoskeletal and connective tissue disorders | NCI v3.0 |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | NCI v3.0 |
|
| cough | Respiratory, thoracic and mediastinal disorders | NCI v3.0 |
|
| wheeze | Respiratory, thoracic and mediastinal disorders | NCI v3.0 |
|
Not provided
Not provided
Not provided
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| Title | Measurements |
|---|
|
| shortness of breath |
|
| wheeze |
|