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| Name | Class |
|---|---|
| University of Maryland Greenebaum Cancer Center | OTHER |
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Neoadjuvant Paclitaxel Poliglumex (PPX; CT-2103), Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial. (CTI#X64001
32 patients with esophageal or gastroesophageal junction cancer will receive Radiation:50.4 Gy at 180cGy fraction/day for 28 treatments and Paclitaxel Poliglumex (PPX) and Cisplatin weekly times 6 followed by surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PPX with cisplatin and radiation | Experimental | PPX 50mg/m2 wk and cisplatin 25mg/m2 wk for 6 weeks with 50.4 GY concurrent radiation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PPX with cisplatin and radiation | Drug | weekly IV treatment of Paclitaxel Poliglumex and Cisplatin for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Pathologic Response | Per pathology review post surgery | At Surgery approximately 4weeks after last treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Howard Safran, MD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lifespan Hospitals | Providence | Rhode Island | 02903 | United States |
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Accrual closed in August 2009, 40 patients were enrolled
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| ID | Title | Description |
|---|---|---|
| FG000 | PPX, Cisplatin, Radiation |
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PPX, Cisplatin, Radiation |
|
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Complete Pathologic Response | Per pathology review post surgery | Twelve of 37 patients (32%) had pathologic complete responses. The 12 patients with pathologic CR all had adenocarcinoma. | Posted | Number | participants | At Surgery approximately 4weeks after last 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 | PPX, Cisplatin, Radiation |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| esophagitis, nauseam dehydration, electrolyte imbalance, potassium and mood alteration | Investigations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| esophagitis | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kayla Rosati | BrUOG | 401-863-3000 | Kayla_Rosati@brown.edu |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C080406 | protein phosphatase 4 |
| D002945 | Cisplatin |
| D011827 | Radiation |
| C509139 | paclitaxel poliglumex |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 14 |
| 40 |
| 2 |
| 40 |
| allergic reaction/hypersensitivity | Investigations | Systematic Assessment |
|
| nausea, dehydration, esophagitis, death | Investigations | Systematic Assessment | death related to progressive disease and carcinoma meningitis |
|
| multiorgan failure | Investigations | Systematic Assessment | post op esophagectomy 2 1/2 months post chemotherapy not related to chemotherapy |
|
| leukopenia, esophagitis, dehydration, nausea, vomiting, neutropenia, hypotension | Investigations | Systematic Assessment |
|
| hyperglycemia, dehydration | Investigations | Systematic Assessment |
|
| infection of gallbladder with normal ANC | Investigations | Systematic Assessment |
|
| dysphagia, dizziness, dehydration | Investigations | Systematic Assessment |
|
| hypokalemia, hypomagnesemia, weakness, anorexia, opportunistic infection | Investigations | Systematic Assessment |
|
| thrombosis, hematoma, hypomagnesemia, extrapyramidal/restless | Investigations | Systematic Assessment |
|
| nausea, vomiting, weakness, ischemic colitis | Investigations | Systematic Assessment |
|
| thrombosis/embolism | Investigations | Systematic Assessment |
|
| infection with normal ANC (cellulitis) and albumin | Investigations | Systematic Assessment |
|
| pneumothorax | Investigations | Systematic Assessment |
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| DVT | Investigations | Systematic Assessment |
|
| acute vascular leak, GI other, hypotension, anorexia, hypothermia,INR | Investigations | Systematic Assessment | GI other is abdominal compartment syndrome |
|
| abdominal pain and dehydration | Investigations | Systematic Assessment |
|
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| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D055585 |
| Physical Phenomena |