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
Not provided
Not provided
This purpose of this study is to determine the highest tolerated dose of Stereotactic Body Radiation Therapy (SBRT) and also to determine the appropriate dose for intact pancreatic cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Radiation: 10 Gy x3 | Experimental | Level 1 - SBRT 10Gy in three doses over ten days (total 30 Gy). |
|
| Stereotactic Radiation: 12.5 Gy x3 | Experimental | Level 2 - SBRT 12.5Gy in three doses over ten days (total 37.5 Gy). |
|
| Stereotactic Radiation: 15 Gy x3 | Experimental | Level 3 - SBRT 15Gy in three doses over ten days (total 45 Gy). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Radiation 10 Gy | Radiation | 10 Gy three times over 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (Phase 1) | Side effects will be assessed after 28 days of treatment to determine tolerability of the dose of radiation. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Patients With Late (>28 Days) Grade 3+ GI Toxicity | Grade 3+ GI late toxicity | 12 months after treatment |
| Number of Participants With an Improvement in Patient Reported Pain Score Using Visual Analog Scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stanley Liauw, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
Excluded Patients (n = 2) due to screening failures
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Stereotactic Radiation: 10 Gy x3 | Level 1 - SBRT 10Gy in three doses over ten days (total 30 Gy). |
| FG001 | Stereotactic Radiation: 12.5 Gy x3 | Level 2 - SBRT 12.5Gy in three doses over ten days (total 37.5 Gy). |
| FG002 | Stereotactic Radiation: 15 Gy x3 | Level 3 - SBRT 15Gy in three doses over ten days (total 45 Gy). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Stereotactic Radiation: 10 Gy x3 | Level 1 - SBRT 10Gy in three doses over ten days (total 30 Gy). |
| BG001 | Stereotactic Radiation: 12.5 Gy x3 | Level 2 - SBRT 12.5Gy in three doses over ten days (total 37.5 Gy). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Maximum Tolerated Dose (Phase 1) | Side effects will be assessed after 28 days of treatment to determine tolerability of the dose of radiation. | Posted | Number | Gy | 28 days |
|
|
Adverse events as specified in the protocol to meet the definition of dose-limiting toxicity or acute adverse events were monitored for only one month. Serious adverse events ( late GI toxicity) were followed for up to 12 months after treatment. All-cause mortality was assessed over a longer period, which in this case was until death for all enrolled patients and up to 8 years.
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 Radiation: 10 Gy x3 | Level 1 - SBRT 10Gy in three doses over ten days (total 30 Gy). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal bleeding | Gastrointestinal disorders | CTCAE v3.0. | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | CTCAE v3.0. | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stanley Liauw | The University of Chicago | (773) 702-0817 | Stanley.Liauw@uchospitals.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 2, 2014 | Sep 23, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Stereotactic Radiation 12.5 Gy | Radiation | 12.5 Gy three times over 10 days |
|
| Stereotactic Radiation 15 Gy | Radiation | 15 Gy three times over 10 days |
|
Using the visual analog scale, patients rate pain from 1-10 with higher scores indicate greater pain intensity. Improvement in pain is defined as a yes/no response.
| 12 months after treatment |
| Number of Patients Eligible for Surgery to Remove Tumor After Treatment | 12 months after treatment |
| Number of Patients With Local Disease Control | Number of patients with no disease progression as measured by tumor imaging, based on RECIST criteria | 12 months after treatment |
| Change From Baseline in Patient Reported Outcomes Using FACT-Hepatobiliary (FACT-Hep) Quality of Life Questionnaire. | The Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) is an instrument that assesses health-related quality of life in patients with hepatobiliary cancers. The FACT-Hep consists of the FACT-G, which assesses generic health-related quality of life and concerns, and a validated Hepatobiliary Subscale (HS), which assesses disease-specific issues. Responses are on a 5 point Likert-type scale; items are summed to generate scores, with higher scores indicating better QOL (possible range of total score = 0-180). | 12 months after treatment |
| BG002 | Stereotactic Radiation: 15 Gy x3 | Level 3 - SBRT 15Gy in three doses over ten days (total 45 Gy). |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | The Number of Patients With Late (>28 Days) Grade 3+ GI Toxicity | Grade 3+ GI late toxicity | Posted | Number | participants | 12 months after treatment |
|
|
|
| Secondary | Number of Participants With an Improvement in Patient Reported Pain Score Using Visual Analog Scale | Using the visual analog scale, patients rate pain from 1-10 with higher scores indicate greater pain intensity. Improvement in pain is defined as a yes/no response. | Only eight patients of enrolled patients across all dose levels had pain at presentation and were eligible for this secondary outcome of pain response | Posted | Count of Participants | Participants | 12 months after treatment |
|
|
|
| Secondary | Number of Patients Eligible for Surgery to Remove Tumor After Treatment | Posted | Number | participants | 12 months after treatment |
|
|
|
| Secondary | Number of Patients With Local Disease Control | Number of patients with no disease progression as measured by tumor imaging, based on RECIST criteria | Posted | Number | participants | 12 months after treatment |
|
|
|
| Secondary | Change From Baseline in Patient Reported Outcomes Using FACT-Hepatobiliary (FACT-Hep) Quality of Life Questionnaire. | The Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) is an instrument that assesses health-related quality of life in patients with hepatobiliary cancers. The FACT-Hep consists of the FACT-G, which assesses generic health-related quality of life and concerns, and a validated Hepatobiliary Subscale (HS), which assesses disease-specific issues. Responses are on a 5 point Likert-type scale; items are summed to generate scores, with higher scores indicating better QOL (possible range of total score = 0-180). | This measure was added to the study protocol when accrual for the third cohort began and thus was only assessed in the third (15 Gy x3) cohort. Among this cohort, baseline data was only collected for 5 patients and only 1 of these patients had 12 month data, which was optional, and that is what is summarized here. | Posted | Mean | Standard Deviation | score on a scale | 12 months after treatment |
|
|
|
| 3 |
| 3 |
| 2 |
| 3 |
| 1 |
| 3 |
| EG001 | Stereotactic Radiation: 12.5 Gy x3 | Level 2 - SBRT 12.5Gy in three doses over ten days (total 37.5 Gy). | 3 | 3 | 0 | 3 | 3 | 3 |
| EG002 | Stereotactic Radiation: 15 Gy x3 | Level 3 - SBRT 15Gy in three doses over ten days (total 45 Gy). | 9 | 9 | 2 | 9 | 7 | 9 |
| Fatigue | General disorders | CTCAE v3.0. | Non-systematic Assessment |
|
| Gastrointestinal bleeding | Gastrointestinal disorders | CTCAE v3.0. | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| 12 months |
|
|