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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00070233 | Other Identifier | JHMIRB |
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The investigators are looking to see if a certain dose of stereotactic body radiation therapy (SBRT) may be a viable treatment option for recurrent or residual pancreatic or periampullary adenocarcinoma.
No standard treatment option has yet been established for patients with recurrent or residual disease after definitive treatment of pancreatic or periampullary cancers (duodenal, ampullary, bile duct). Linac based stereotactic body radiation therapy (SBRT) administered in 1-3 fractions has been shown to be an effective treatment option for patients with unresectable, locally advanced pancreatic adenocarcinoma, achieving local control rates of 84-92% at one year. Associated late gastrointestinal toxicity rates have been reported to be 22-25% at 1 year. We hypothesize that similarly excellent local control rates (80-90% at one year) with a reasonable rate of toxicity (≤20%) can be achieved using Linac based SBRT delivered as 5 Gy x 5 for patients with local failure (remaining disease) after previous treatment with conventional chemoradiation therapy (CRT) with or without surgery and as 6.6 Gy x 5 for radiation-naïve patients with local failure (remaining disease) after previous treatment with surgery and/or chemotherapy. The toxicities of note for this trial are grade 2 and greater gastritis, fistula, enteritis, ulcer, or any other grade 3 or greater gastrointestinal toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Locally advanced pancreatic cancer or locally recurrent pancreatic ductal adenocarcinoma | Experimental | Patients with pathologically confirmed, locally advanced pancreatic ductal adenocarcinoma (LAPC), unresectable at diagnosis, or local recurrence pancreatic ductal adenocarcinoma (PDAC) after prior surgical resection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Radiation | Stereotactic Body Radiation Therapy (SBRT) which included 5 consecutive fractions of 25 to 33 Gy, following 3 months of multiagent chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Late Gastrointestinal Toxicities | Late (Up to 3 months post-treatment to date of first progression or date of death, (whichever comes first-up to 36 months) Grade 2 or greater gastritis, enteritis, fistula, or ulcer and any other grade 3 or greater gastrointestinal toxicity attributable to Stereotactic Body Radiation Therapy (SBRT). Toxicity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 4.0) and the Radiation Therapy Oncology Group radiation morbidity scoring criteria. | 3 months post-treatment to date of first progression or date of death, whichever comes first assessed up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Gastrointestinal Toxicity | Any acute gastrointestinal (GI) toxicities grade 3 or greater. | within 3 months of treatment |
| Local Progression Free Survival From SBRT | Local progression free survival defined as the length of time (months) during and after the treatment of a disease that a patient lives with cancer, but the disease does not worsen. |
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Inclusion Criteria:
18 years of age or older
Karnofsky Performance Status greater than or equal to 70%
confirmed pancreatic or periampullary adenocarcinoma
pancreatic or periampullary tumor less than 8.0 cm in greatest axial dimension
Either:
standard of care treatment for pancreatic cancer that included radiation therapy
* patients may be receiving continued chemotherapy post initial CRT. or
standard of care treatment for pancreatic cancer that did not include radiation therapy * patients must have attempted chemotherapy upon initial diagnosis
acceptable organ and marrow function as determined by blood tests
ability to understand and give consent
must be a patient to be treated with SBRT only at Johns Hopkins Hospital
life expectancy of greater than 3 months
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amol Narang, M.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Locally Advanced Pancreatic Cancer or Locally Recurrent Pancreatic Ductal Adenocarcinoma | Patients with pathologically confirmed, locally advanced pancreatic ductal adenocarcinoma (LAPC), unresectable at diagnosis, or local recurrence pancreatic ductal adenocarcinoma (PDAC) after prior surgical resection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Locally Advanced Pancreatic Cancer or Locally Recurrent Pancreatic Ductal Adenocarcinoma | Patients with pathologically confirmed, locally advanced pancreatic ductal adenocarcinoma (LAPC), unresectable at diagnosis, or local recurrence pancreatic ductal adenocarcinoma (PDAC) after prior surgical resection. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Late Gastrointestinal Toxicities | Late (Up to 3 months post-treatment to date of first progression or date of death, (whichever comes first-up to 36 months) Grade 2 or greater gastritis, enteritis, fistula, or ulcer and any other grade 3 or greater gastrointestinal toxicity attributable to Stereotactic Body Radiation Therapy (SBRT). Toxicity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 4.0) and the Radiation Therapy Oncology Group radiation morbidity scoring criteria. | Posted | Count of Participants | Participants | 3 months post-treatment to date of first progression or date of death, whichever comes first assessed up to 36 months |
|
Up to 36 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Locally Advanced Pancreatic Cancer or Locally Recurrent Pancreatic Ductal Adenocarcinoma | Patients with pathologically confirmed, locally advanced pancreatic ductal adenocarcinoma (LAPC), unresectable at diagnosis, or local recurrence pancreatic ductal adenocarcinoma (PDAC) after prior surgical resection. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Duadenal Ulcer | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ulcer | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amol Narang | Johns Hopkins University, Department of Radiation Oncology | 410-913-3559 | anarang2@jhmi.edu |
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| 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 | Oct 30, 2019 | Jul 26, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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Prospective, non-randomized, controlled Phase 2 trial
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| From date of randomization until the date of first documented progression or death from any cause (up to 36 months). |
| Local Progression Free Survival From Diagnosis | Local progression free survival defined as the length of time (months) during and after the treatment of a disease that a patient lives with cancer, but the disease does not worsen. | From date documented diagnosis to date of first documented local disease progression. |
| Change in Patient Reported Quality of Life (PR-QOL) Assessment at Baseline (Pre-treatment) and 3 Months (Post-Treatment) | To evaluate whether a change in patient reported quality of life (QoL) occurred between baseline (pre-SBRT) and at 3 months (post-SBRT) using the European Organization for Research and Treatment in Cancer quality of life core cancer questionnaire with the pancreatic cancer module (EORTC QLQ-C30/Pan26). This assessment is a multi-dimensional, 30-item questionnaire which assesses 5 functional scales (physical, role, cognitive, emotional and social), 3 symptom scales ( fatigue, pain and nausea/vomiting), a global health/QoL scale as well as 6 single items. There are also 26 questions specific to patients with pancreatic cancer. Scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems. | Baseline (Pre-SBRT) and at 3 months (Post-SBRT) |
| Linear Accelerator (Linac) Based SBRT Pain Control | To evaluate the ability of Linac based SBRT to provide pain control among symptomatic patients as measured by pain medication requirement at 3, 6 and 12 months after treatment. | 3, 6, and 12 months after treatment |
| Linac Based SBRT Standardization | To develop and standardize Linac based SBRT delivery and dosimetric parameters | 3, 6, and 12 months after treatment |
| FDG-PET Use for Planning and Estimation of Survival | To evaluate the utility of FDG-PET for treatment planning and estimation of progression-free survival. | 3, 6, and 12 months after treatment and then annually thereafter |
| Toxicity for Patients With Chemotherapy, Surgery (Resection) and Radiation for Tumor Assessments | Toxicity was assessed for grade ≥2 gastrointestinal toxic effects using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0) and the Radiation Therapy Oncology Group radiation morbidity scoring criteria. | Up to 36 months |
| Toxicity for Patients With Chemotherapy and Radiation (no Resection) | Toxicity was assessed for grade ≥2 gastrointestinal toxic effects using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0) and the Radiation Therapy Oncology Group radiation morbidity scoring criteria. | Up to 36 months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
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| Secondary | Acute Gastrointestinal Toxicity | Any acute gastrointestinal (GI) toxicities grade 3 or greater. | Posted | Count of Participants | Participants | within 3 months of treatment |
|
|
|
| Secondary | Local Progression Free Survival From SBRT | Local progression free survival defined as the length of time (months) during and after the treatment of a disease that a patient lives with cancer, but the disease does not worsen. | Posted | Median | 95% Confidence Interval | Months until local progression | From date of randomization until the date of first documented progression or death from any cause (up to 36 months). |
|
|
|
| Secondary | Local Progression Free Survival From Diagnosis | Local progression free survival defined as the length of time (months) during and after the treatment of a disease that a patient lives with cancer, but the disease does not worsen. | Posted | Median | 95% Confidence Interval | Months until local progression | From date documented diagnosis to date of first documented local disease progression. |
|
|
|
| Secondary | Change in Patient Reported Quality of Life (PR-QOL) Assessment at Baseline (Pre-treatment) and 3 Months (Post-Treatment) | To evaluate whether a change in patient reported quality of life (QoL) occurred between baseline (pre-SBRT) and at 3 months (post-SBRT) using the European Organization for Research and Treatment in Cancer quality of life core cancer questionnaire with the pancreatic cancer module (EORTC QLQ-C30/Pan26). This assessment is a multi-dimensional, 30-item questionnaire which assesses 5 functional scales (physical, role, cognitive, emotional and social), 3 symptom scales ( fatigue, pain and nausea/vomiting), a global health/QoL scale as well as 6 single items. There are also 26 questions specific to patients with pancreatic cancer. Scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems. | Not all patients completed the QOL assessments. In this case 43 of the 48 patients completed assessments. | Posted | Median | 95% Confidence Interval | score on a scale | Baseline (Pre-SBRT) and at 3 months (Post-SBRT) |
|
|
|
| Secondary | Linear Accelerator (Linac) Based SBRT Pain Control | To evaluate the ability of Linac based SBRT to provide pain control among symptomatic patients as measured by pain medication requirement at 3, 6 and 12 months after treatment. | We prioritized collecting and analyzing data for the primary outcome of this study which is reported in ClinicalTrials.gov. Unfortunately, due to lack of funding, we were not able to collect and analyze all secondary outcome data as planned. | Posted | 3, 6, and 12 months after treatment |
|
|
| Secondary | Linac Based SBRT Standardization | To develop and standardize Linac based SBRT delivery and dosimetric parameters | We prioritized collecting and analyzing data for the primary outcome of this study which is reported in ClinicalTrials.gov. Unfortunately, due to lack of funding, we were not able to collect and analyze all secondary outcome data as planned. Therefore, dosimetric parameters were not developed | Posted | 3, 6, and 12 months after treatment |
|
|
| Secondary | FDG-PET Use for Planning and Estimation of Survival | To evaluate the utility of FDG-PET for treatment planning and estimation of progression-free survival. | We prioritized collecting and analyzing data for the primary outcome of this study which is reported in ClinicalTrials.gov. Unfortunately, due to lack of funding, we were not able to collect and analyze all secondary outcome data as planned. | Posted | 3, 6, and 12 months after treatment and then annually thereafter |
|
|
| Secondary | Toxicity for Patients With Chemotherapy, Surgery (Resection) and Radiation for Tumor Assessments | Toxicity was assessed for grade ≥2 gastrointestinal toxic effects using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0) and the Radiation Therapy Oncology Group radiation morbidity scoring criteria. | Participants who had chemotherapy, surgery (resection) and radiation. | Posted | Count of Participants | Participants | Up to 36 months |
|
|
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| Secondary | Toxicity for Patients With Chemotherapy and Radiation (no Resection) | Toxicity was assessed for grade ≥2 gastrointestinal toxic effects using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0) and the Radiation Therapy Oncology Group radiation morbidity scoring criteria. | Participants who had chemotherapy and radiation (no resection) | Posted | Count of Participants | Participants | Up to 36 months |
|
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|
| 45 |
| 48 |
| 10 |
| 48 |
| 3 |
| 48 |
| Liver Abcess | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Enteritis | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
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| Bowel Obstruction | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Gastrointestinal Bleed | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 4 |
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| Gastrointestinal Bleed | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Grade 3 |
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| Vomiting/Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Biliary Obstruction | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Fistula | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Enteritis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bowel Obstruction | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |