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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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The purposes of this study are:
Before entering this study the doctor will examine the patient and order blood tests. These tests will use approximately 10 ml of blood. Blood work should be done within 3 weeks prior to treatment.. Women of child-bearing potential are required to have a pregnancy test done within 7 days prior to the start of treatment . A CT or a PET/CT scan of the chest, abdomen and pelvis will be done within 4 weeks prior to starting treatment . All subjects participating in this study will receive radiation therapy and chemotherapy. Patients will get 4 cycles of chemotherapy along with radiation. Each cycle of chemotherapy consists of gemcitabine given i.v. on day 1 and day 8 of treatment. XRT is given on days 1 and 2 and on days 8 and 9 twice a day. This works out to 8 treatments of XRT per course of chemo. Overall, a total of 32 treatments of radiation therapy will be given during the 4 sessions of chemotherapy. Blood work for CBC with differential and platelets will be done prior to each dose of chemotherapy.The investigational portion of this study is the radiation therapy given to the abdomen on the same day and the day after the patient receives chemotherapy. Three-Four weeks after treatment completion the patient will be evaluated again. The treating physician will examine the patient and order blood tests. These tests will use approximately 10 ml of blood. The physician will also order a repeat CT or PET/CT to compare the disease status after treatment. These tests are not experimental and are part of routine check-ups of patients with pancreatic cancer. Patients will be followed for survival. Protected health information will not be reviewed by someone other than the patient's provider to identify potential subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | Gemcitabine will be given at 1250 mg per meter squared over 2 hours days 1 and 8 of a 21 day cycle for a total of 4 cycles. Radiation: External Radiation Therapy The total dose would be 19.2 Gy divided over 32 fractions twice a day, on day 1 and day 8 after chemotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine will be given at 1250 mg per meter squared over 2 hours days 1 and 8 of a 21 day cycle for a total of 4 cycles. Radiation:External Radiation Therapy The total dose would be 19.2 Gy divided over 32 fractions twice a day, on day 1 and day 8 after chemotherapy. **Radiation is the experimental part of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | 3 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Distant Mestastases - Liver | Patients with distant mestastases to the liver | Participants were followed for an average of 8 years |
| Time of Advanced/Recurrent Disease Without Distant Metastases. |
Inclusion Criteria:
10 .Patients may have brain metastasis if these brain metastasis are well controlled by usual clinical criteria and if the life expectancy is at least 3 months. Any patient with brain metastasis must be cleared by the principal investigator.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Regine, MD | Chair - University of Maryland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland & Baltimore VA medical centre | Baltimore | Maryland | 21201 | United States | ||
| Juravinski Cancer Centre |
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All patients with cancer are seen by a multi-discipline clinic (medical, surgical, radiotherapy, etc). The PI or Co-PI identifies eligible candidates and initiates the discussion of research participation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gem(1250mg/m2, d1, 8) +LDFRT (60cGy/fx BID, d1,2,8,9) | 4 cycles (1 cycle = 21 days): Gemcitabine 1250/m2 given IV Day 1 and Day 8; with concurrent Low Dose Fractionated Radiation Therapy (LDFRT). The total Radiation dose would be 19.2 Gy divided over 32 fractions. Treatment will be given in 2 fractions with a minimum 4 hr inter-fraction interval, not to exceed 6 hours. Radiotherapy given after the initiation of Gemcitabine Days 1,2,8, and 9. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Locally advanced/recurrent disease without distant metastases.
| Participants were followed for an average of 8 years |
| Hamilton |
| Ontario |
| L8V 5C2 |
| Canada |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Chemotherapy, Gemcitabine With Concurrent Low Dose Ra |
| 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 | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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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 | Overall Response | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Posted | Number | participants | 3 weeks |
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| Other Pre-specified | Percentage of Participants With Distant Mestastases - Liver | Patients with distant mestastases to the liver | Posted | Number | 95% Confidence Interval | percentage of participants | Participants were followed for an average of 8 years |
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| Other Pre-specified | Time of Advanced/Recurrent Disease Without Distant Metastases. | Locally advanced/recurrent disease without distant metastases. | Posted | Median | 95% Confidence Interval | months | Participants were followed for an average of 8 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 | Standard Chemotherapy, Gemcitabine With Concurrent Low Dose Ra | 17 | 38 | 4 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematologic | Blood and lymphatic system disorders | Systematic Assessment | Hematologic toxicities, (combined any WBC, HGB, PLTs, ANC) grade 4 experienced in 17 out of 38 participants. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection - non-neutropenic | Infections and infestations | Non-neutropenic | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy Kennedy | University of Maryland Baltimore | 410-328-2513 | nkennedy@umm.edu |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D010051 | Ovarian Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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