| ID | Type | Description | Link |
|---|---|---|---|
| HUM 4531 | Other Identifier | University of Michigan IRBMED |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
| Johns Hopkins University | OTHER |
| Princess Margaret Hospital, Canada | OTHER |
| Ohio State University |
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This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer.
This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer. This research treatment will evaluate the combination of two chemotherapy agents, oxaliplatin and gemcitabine with radiation therapy. The researchers have already done studies using oxaliplatin, gemcitabine and radiation therapy together for pancreatic cancer. They want to build on the information they have from this previous research and do the research at multiple sites. They will use this study to determine how well people do who are treated with gemcitabine, oxaliplatin, and radiation therapy prior to having surgery for their pancreatic cancer. The researchers will also gather more information about what type of side effects occur with this treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxaliplatin & gemcitabine with radiation | Experimental | This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine | Drug | Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1, 8, and 15 of a treatment cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Two-year Disease Free Survival. | The percent of patients alive and disease-free at two years. | two years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Treatment Failure | Median time for disease recurrence after surgery. | 2 years |
| Overall Survival | Percent overall survival was calculated for all evaluable patients. |
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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 |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21231 | United States | ||
| University of Michigan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23720019 | Result | Kim EJ, Ben-Josef E, Herman JM, Bekaii-Saab T, Dawson LA, Griffith KA, Francis IR, Greenson JK, Simeone DM, Lawrence TS, Laheru D, Wolfgang CL, Williams T, Bloomston M, Moore MJ, Wei A, Zalupski MM. A multi-institutional phase 2 study of neoadjuvant gemcitabine and oxaliplatin with radiation therapy in patients with pancreatic cancer. Cancer. 2013 Aug 1;119(15):2692-700. doi: 10.1002/cncr.28117. Epub 2013 May 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gemcitabine and Oxaliplatin With Radiation Therapy | Gemcitabine and Oxaliplatin with radiation therapy in localized pancreatic cancer. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
68 patients were evaluable. 71 patients were enrolled however 1 was removed from study during cycle 1 due to non-compliance and 2 additional patients withdrew for reasons not related to toxicity or progression.
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxaliplatin & Gemcitabine With Radiation | Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray [Gy] fractions (total dose, 30 Gy). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Two-year Disease Free Survival. | The percent of patients alive and disease-free at two years. | 43 patients underwent resection. 41 of the 43 had R0/R1 (surgical margin status) resection. Patients with R02 surgical margins (portions of the tumor visible to the naked eye were not removed) were not included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of patients | two years |
|
Adverse Events (AEs) were captured on day 1 until 30 days post treatment.
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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 | Oxaliplatin & Gemcitabine With Radiation | Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray [Gy] fractions (total dose, 30 Gy). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (Unspecified) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | CTCAE (Unspecified) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Zalupski, MD | University of Michigan | 734-615-3969 | zalupski@med.umich.edu |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000077150 | Oxaliplatin |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| OTHER |
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| oxaliplatin | Drug | Oxaliplatin 85mg/m2 will be infused following gemcitabine over approximately 90 minutes on days 1 and 15 of a treatment cycle. |
|
|
| Radiation | Procedure | The total dose in a three week treatment block will be 30 Gy in 2.0 Gy fractions. |
|
|
| 5 years |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Time to Treatment Failure | Median time for disease recurrence after surgery. | 43 patients underwent resection. 41 of the 43 had R0/R1 (surgical margin status) resection. Patients with R02 surgical margins (portions of the tumor visible to the naked eye were not removed) were not included in the analysis. | Posted | Median | Full Range | months | 2 years |
|
|
|
| Secondary | Overall Survival | Percent overall survival was calculated for all evaluable patients. | Of the 71 eligible patients, 68 were evaluable for overall response (1 patient was removed from study during cycle 1 for noncompliance, and 2 additional patients withdrew for reasons not related to toxicity or progression). | Posted | Median | 95% Confidence Interval | months | 5 years |
|
|
|
| 28 |
| 71 |
| 57 |
| 71 |
| Alanine aminotransferase increased | Investigations | CTCAE (Unspecified) |
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| Alkaline phosphatase increased | Investigations | CTCAE (Unspecified) |
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| Anorexia | Gastrointestinal disorders | CTCAE (Unspecified) |
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| Aspartate aminotransferase increased | Investigations | CTCAE (Unspecified) |
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| Bile duct stenosis | Hepatobiliary disorders | CTCAE (Unspecified) |
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| Cardiac disorder | Cardiac disorders | CTCAE (Unspecified) |
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| Cardiac ischemia/infarction | Cardiac disorders | CTCAE (Unspecified) |
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| Chest pain | Cardiac disorders | CTCAE (Unspecified) |
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| Creatine phosphokinase increased | Investigations | CTCAE (Unspecified) |
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| Death | General disorders | CTCAE (Unspecified) |
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| Dehydration | Metabolism and nutrition disorders | CTCAE (Unspecified) |
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| Duodenal ulcer | Gastrointestinal disorders | CTCAE (Unspecified) |
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| Edema limbs | General disorders | CTCAE (Unspecified) |
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| Enteritis | Gastrointestinal disorders | CTCAE (Unspecified) |
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| Fatigue | General disorders | CTCAE (Unspecified) |
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| Fever | General disorders | CTCAE (Unspecified) |
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| GI - Other (Specify) | Gastrointestinal disorders | CTCAE (Unspecified) |
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| Gastrointestinal pain | Gastrointestinal disorders | CTCAE (Unspecified) |
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| General symptom | General disorders | CTCAE (Unspecified) |
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| Hemoglobin decreased | Blood and lymphatic system disorders | CTCAE (Unspecified) |
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| Hepatobiliary - Other (Specify) | Hepatobiliary disorders | CTCAE (Unspecified) |
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| Hyperbilirubinemia | Investigations | CTCAE (Unspecified) |
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| Infection, Biliary tree | Infections and infestations | CTCAE (Unspecified) |
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| Leukocytes | Investigations | CTCAE (Unspecified) |
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| Leukopenia | Investigations | CTCAE (Unspecified) |
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| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (Unspecified) |
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| Lymph leakage | Vascular disorders | CTCAE (Unspecified) |
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| Lymphopenia | Investigations | CTCAE (Unspecified) |
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| Nausea | Gastrointestinal disorders | CTCAE (Unspecified) |
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| Neutrophil count decreased | Investigations | CTCAE (Unspecified) |
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| Neutrophils | Investigations | CTCAE (Unspecified) |
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| Opportunisitic infection | Infections and infestations | CTCAE (Unspecified) |
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| Platelet count decreased | Investigations | CTCAE (Unspecified) |
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| Platelets | Investigations | CTCAE (Unspecified) |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) |
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| Thrombosis | Vascular disorders | CTCAE (Unspecified) |
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| Vomiting | Gastrointestinal disorders | CTCAE (Unspecified) |
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| Diarrhea | Gastrointestinal disorders | CTCAE (Unspecified) |
|
| Fatigue | General disorders | CTCAE (Unspecified) |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (Unspecified) |
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| Hemoglobin decreased | Blood and lymphatic system disorders | CTCAE (Unspecified) |
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| Hyperbilirubinemia | Investigations | CTCAE (Unspecified) |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (Unspecified) |
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| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (Unspecified) |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE (Unspecified) |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE (Unspecified) |
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| Leukocytes | Blood and lymphatic system disorders | CTCAE (Unspecified) |
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| Leukopenia | Investigations | CTCAE (Unspecified) |
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| Lymphopenia | Investigations | CTCAE (Unspecified) |
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| Nausea | Gastrointestinal disorders | CTCAE (Unspecified) |
|
| Neutrophil count decreased | Investigations | CTCAE (Unspecified) |
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| Neutrophils | Investigations | CTCAE (Unspecified) |
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| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (Unspecified) |
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| Platelet count decreased | Investigations | CTCAE (Unspecified) |
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| Platelets | Investigations | CTCAE (Unspecified) |
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| Taste alteration | Nervous system disorders | CTCAE (Unspecified) |
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| Vomiting | Gastrointestinal disorders | CTCAE (Unspecified) |
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| Weight loss | Metabolism and nutrition disorders | CTCAE (Unspecified) |
|
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D055585 | Physical Phenomena |