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To assess the feasibility of administering induction chemotherapy with gemcitabine and docetaxel followed by concurrent radiation and continuous infusion 5FU and consolidation gemcitabine/docetaxel chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (gemcitabine, docetaxel, 5FU, radiation) | Experimental | Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles 5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2) Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week. Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation) Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine | Drug |
|
| |
| Docetaxel |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Severe Toxicities | Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0 | 1 month after completion of treatment (treatment lasts approximately 19 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicities Associated With Treatment (Grade 1-2) | Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 1-2 non-hematologic and hematologic toxicities were collected for this outcome. | 30 days after completion of treatment (treatment lasts approximately 19 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Tan, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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The study opened to participants enrollment on 09/14/2002 and closed to participant enrollment on 11/06/2012
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 (Gemcitabine, Docetaxel, 5FU, Radiation) | Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles 5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2) Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week. Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation) Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
|
| Radiation | Radiation |
|
| Toxicities Associated With Treatment (Grade 3-4) |
Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 3-4 non-hematologic and hematologic toxicities were collected for this outcome. |
| 30 days after completion of treatment (treatment lasts approximately 19 weeks) |
| Disease Free Survival (DFS) - Median | DFS was defined as the time from the initiation of treatment to relapse or death, whichever occurred first. | Median follow-up was 24 months (range 3.2-97 months) |
| Overall Survival (OS) - Median | OS was defined as the time from the initiation of treatment to death from any cause or last follow-up. | Median follow-up was 24 months (range 3.2-97 months) |
| Overall Survival (OS) | OS was defined as the time from the initiation of treatment to death from any cause or last follow-up | 1 year |
| Overall Survival (OS) | OS was defined as the time from the initiation of treatment to death from any cause or last follow-up | 2 years |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 (Gemcitabine, Docetaxel, 5FU, Radiation) | Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles 5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2) Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week. Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation) Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Overall stage | -There are some staging differences between biliary tract cancer, pancreatic cancer, and ampullary cancer but general staging information is listed below:
| Number | participants |
| ||||||||||||||||||||||
| Disease type | Number | participants |
| |||||||||||||||||||||||
| T-stage |
| Number | participants |
| ||||||||||||||||||||||
| N-stage | N describes the spread to nearby (regional) lymph nodes. X: Nearby (regional) lymph nodes cannot be assessed. N0: The cancer has not spread to nearby lymph nodes. N1: The cancer has spread to nearby lymph nodes. | Number | participants |
| ||||||||||||||||||||||
| Differentiation | Well-differentiated cancer cells look more like normal cells and tend to grow and spread more slowly than poorly differentiated or undifferentiated cancer cells. | Number | participants |
| ||||||||||||||||||||||
| Lymphovascular involvement | Number | participants |
| |||||||||||||||||||||||
| CA 19-9 (tumor marker) |
| Number | 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 | Incidence of Severe Toxicities | Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0 | Posted | Number | percentage of participants | 1 month after completion of treatment (treatment lasts approximately 19 weeks) |
|
|
| |||||||||||||||||||||||||||
| Secondary | Toxicities Associated With Treatment (Grade 1-2) | Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 1-2 non-hematologic and hematologic toxicities were collected for this outcome. | Posted | Number | percentage of participants | 30 days after completion of treatment (treatment lasts approximately 19 weeks) |
|
| ||||||||||||||||||||||||||||
| Secondary | Toxicities Associated With Treatment (Grade 3-4) | Toxicity was graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0. The most common grade 3-4 non-hematologic and hematologic toxicities were collected for this outcome. | Posted | Number | percentage of participants | 30 days after completion of treatment (treatment lasts approximately 19 weeks) |
|
| ||||||||||||||||||||||||||||
| Secondary | Disease Free Survival (DFS) - Median | DFS was defined as the time from the initiation of treatment to relapse or death, whichever occurred first. | Posted | Median | 95% Confidence Interval | months | Median follow-up was 24 months (range 3.2-97 months) |
|
| |||||||||||||||||||||||||||
| Secondary | Disease Free Survival (DFS) - Median | DFS was defined as the time from the initiation of treatment to relapse or death, whichever occurred first. | 30 out of 48 participants completed all components of the study therapy. | Posted | Median | 95% Confidence Interval | months | Median follow-up was 24 months (range 3.2-97 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) - Median | OS was defined as the time from the initiation of treatment to death from any cause or last follow-up. | Posted | Median | 95% Confidence Interval | months | Median follow-up was 24 months (range 3.2-97 months) |
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from the initiation of treatment to death from any cause or last follow-up | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year |
|
| |||||||||||||||||||||||||||
| Post-Hoc | Incidence of Disease Recurrence | Posted | Number | percentage of participants | Median follow-up was 24 months (range 3.2-97 months) |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from the initiation of treatment to death from any cause or last follow-up | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years |
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) - Median | OS was defined as the time from the initiation of treatment to death from any cause or last follow-up. | 30 out of 48 participants completed all components of study treatment. | Posted | Median | 95% Confidence Interval | months | Median follow-up was 24 months (range 3.2-97 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from the initiation of treatment to death from any cause or last follow-up | 30 out of 48 participants completed all components of study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year |
|
|
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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 | Arm 1 | Gemcitabine 1000 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles Docetaxel 35 mg/m2 IV on Day 1 and Day 8 of a 21 day cycle for 2 cycles 5FU CIVI 225 mg/m2 per day throughout radiation (starts 3 weeks after start of cycle 2) Radiation 5040 cGy or 5400 cGy for positive margins (starts 3 weeks after start of cycle 2). Daily dose of 1.8 Gy five days per week. Gemcitabine 1000 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation) Docetaxel 35 mg/m2 IV on Days 1 and 8 of 21 day cycle for 2 cycles (this starts 4 weeks after radiation) | 16 | 48 | 48 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal cystic lesion | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cavitary lung lesion | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Death | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Edema | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Febrile neutropenia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Generalized weakness | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Granulocytes | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Ileus, GI | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Leukopenia | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Platelets | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Thrombosis/embolism | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alkaline phosphatase | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| BUN | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Bilirubin | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Chills | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Creatinine | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Edema | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Eye | Eye disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Granulocytes | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Hand/foot syndrome | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hematochezia | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hemorrhage | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Leukopenia | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Other neurologic | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Platelets | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| SGOT/SGPT | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Sensory neuropathy | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Skin-photosensitivity | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Sweating | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Thrombosis/embolism | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Thrush | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Urinary tract infection | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Weight loss | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Tan, M.D. | Washington University School of Medicine | 314-362-5740 | btan@dom.wustl.edu |
| ID | Term |
|---|---|
| D005706 | Gallbladder Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D018281 | Cholangiocarcinoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D005705 | Gallbladder Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000077143 | Docetaxel |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D055585 | Physical Phenomena |
Not provided
Not provided
| Title |
|---|
| Measurements |
|---|
|
| III |
|
| IV |
|
| Ampullary cancer |
|
| 3 |
|
| 4 |
|
| X |
|
| Poor |
|
| Not reported |
|
| Not Reported |
|
| >100 |
|
|
|
|
|
|
|
|
|
|
|