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| ID | Type | Description | Link |
|---|---|---|---|
| IRB #HUM3315 | Other Identifier | University of Michigan Medical IRB |
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| Name | Class |
|---|---|
| Rush University Medical Center | OTHER |
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This is a research study for pancreatic cancer. One way of improving the results of current standard treatments is to try new approaches. This study will examine the use of a more advanced radiation therapy technique, called intensity modulated radiation therapy (IMRT), with chemotherapy. All subjects on this study will be treated with gemcitabine. This chemotherapy agent has been used for patients with pancreatic cancer. The researchers have already done studies using radiation therapy and gemcitabine. They want to build on the information they have from this previous research. The researchers want to find the best dose of IMRT that can be given at the same time that patients are receiving gemcitabine. To do this, they will vary the total dose of radiation received by patients on this study based on the information they have available from previously treated patients. The goal of the research is to identify the highest dose of IMRT that can be given at the same time as the chemotherapy without causing severe side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation Dose Escalation with Gemcitabine | Experimental | INTENSITY MODULATED RADIOTHERAPY Radiation dose escalation: Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4
Gemcitabine: 1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INTENSITY MODULATED RADIOTHERAPY | Radiation | Five fractions weekly, fraction size determined by dose level |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Maximum Tolerated Radiation Dose | The maximum tolerated radiation dose delivered with intensity-modulated radiotherapy (IMRT) and concurrent gemcitabine in patients with unresectable adenocarcinoma of the pancreas. | 13 weeks post radiation |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants Free From Local Progression at 2 Years | 2 Years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Zalupski, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612-3833 | United States | ||
| University Of Michigan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiation Dose Escalation With Gemcitabine | INTENSITY MODULATED RADIOTHERAPY Radiation dose escalation: Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4
Gemcitabine: 1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Gemcitabine | Drug | 1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment |
|
| Ann Arbor |
| Michigan |
| 48109-5010 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiation Dose Escalation With Gemcitabine | INTENSITY MODULATED RADIOTHERAPY Radiation dose escalation: Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4
Gemcitabine: 1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment |
| 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, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Tumor Location | Location of tumor within the pancreas | Number | participants |
| ||||||||||||||||||||||
| Tumor Size | Median | Full Range | centimeters (cm) |
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| Tumor Volume | Median | Full Range | Cubic Centimeter (cc) |
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| Baseline CA 19-9 | The CA 19-9 is a simple blood test that measures the level of antigens in the blood serum of a person with pancreatic cancer. | Median | Full Range | Units Per Millilitre (U/mL) |
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| 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 | The Maximum Tolerated Radiation Dose | The maximum tolerated radiation dose delivered with intensity-modulated radiotherapy (IMRT) and concurrent gemcitabine in patients with unresectable adenocarcinoma of the pancreas. | Posted | Number | Gray (Gy) | 13 weeks post radiation |
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| Secondary | The Percentage of Participants Free From Local Progression at 2 Years | Posted | Number | 95% Confidence Interval | percentage of participants | 2 Years |
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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 | Radiation Dose Escalation With Gemcitabine | INTENSITY MODULATED RADIOTHERAPY Radiation dose escalation: Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4
Gemcitabine: 1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment | 34 | 50 | 31 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders |
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| Leukocytes (total WBC) | Blood and lymphatic system disorders |
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| Lymphopenia | Blood and lymphatic system disorders |
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| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders |
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| Platelets | Blood and lymphatic system disorders |
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| Hypotension | Cardiac disorders |
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| Fatigue | General disorders |
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| Fever | General disorders |
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| Rigors/chills | General disorders |
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| Weight loss | General disorders |
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| Rash/desquamation | Skin and subcutaneous tissue disorders |
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| Anorexia | Gastrointestinal disorders |
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| Ascites (non-malignant) | Gastrointestinal disorders |
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| Nausea | Gastrointestinal disorders |
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| Obstruction, GI, Stomach | Gastrointestinal disorders |
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| Ulcer, GI, Duodenum | Gastrointestinal disorders |
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| Vomiting | Gastrointestinal disorders |
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| Hemorrhage, GI, Abdomen NOS | Vascular disorders |
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| Hemorrhage, GI, Duodenum | Vascular disorders |
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| Hemorrhage, GI, Varices | Vascular disorders |
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| Hepatobiliary/Pancreas - Other | Hepatobiliary disorders |
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| Liver dysfunction/failure | Hepatobiliary disorders |
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| Infection with Grade 3 or 4 neutrophils, Abdomen | Infections and infestations |
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| Infection with Grade 3 or 4 neutrophil, Blood | Infections and infestations |
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| Infection with Grade 3 or 4 neutrophils, Duodenum | Infections and infestations |
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| Infection with Grade 3 or 4 neutrophils, Lung | Infections and infestations |
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| Infection, Duodenum | Infections and infestations |
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| Infection, Skin | Infections and infestations |
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| Infection, Urinary Tract | Infections and infestations |
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| Infection, Blood | Infections and infestations |
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| Edema: limb | General disorders |
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| ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders |
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| AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders |
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| Alkaline phosphatase | Metabolism and nutrition disorders |
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| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders |
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| Potassium, serum-high (hyperkalemia) | Metabolism and nutrition disorders |
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| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders |
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| Muscle weakness | Musculoskeletal and connective tissue disorders |
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| Confusion | Nervous system disorders |
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| Neurology - Other | Nervous system disorders |
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| Pain, Abdomen | Gastrointestinal disorders |
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| Pain, Chest | Cardiac disorders |
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| Pain, Extremity-limb | Musculoskeletal and connective tissue disorders |
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| Pain, Penis | Renal and urinary disorders |
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| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders |
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| Renal failure | Renal and urinary disorders |
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| Thrombosis/thrombus/embolism | Vascular disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders |
| |||
| Leukocytes (total WBC) | Blood and lymphatic system disorders |
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| Lymphopenia | Blood and lymphatic system disorders |
| |||
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders |
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| Platelets | Blood and lymphatic system disorders |
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| Fatigue | General disorders |
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| Fever | General disorders |
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| Anorexia | Gastrointestinal disorders |
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| Nausea | Gastrointestinal disorders |
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| Vomiting | Gastrointestinal disorders |
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| Hemorrhage, GI | Vascular disorders |
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| Hepatobiliary/Pancreas | Hepatobiliary disorders |
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| ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders |
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| AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders |
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| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders |
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| Pain, Abdomen | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Zalupski | University of Michigan Comprehensive Cancer Center | 734-615-3969 | zalupski@umich.edu |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Body/Tail |
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