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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 November 2012 |
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Main ID: |
NCT00544193 |
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Date of registration:
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13/10/2007 |
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Primary sponsor: |
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Public title:
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Gemcitabine and Radiation Therapy in Treating Patients With Locally Advanced Upper Gastrointestinal Cancer
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Scientific title:
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Pilot Study of Gemcitabine and IORT/EBRT in Locally Advanced Upper Gastrointestinal Malignancies |
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Date of first enrolment:
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December 1997 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00544193 |
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Study type:
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Interventional |
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Study design:
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Primary Purpose: Treatment
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Contacts
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Name:
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Stephen I. Shibata, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Beckman Research Institute |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Diagnosis of any of the following upper gastrointestinal malignancies:
- Localized pancreatic adenocarcinoma
- Stage I, II, or III disease
- Parapancreatic node involvement and locally recurrent disease allowed
- Locally advanced biliary, gallbladder, or ampullary adenocarcinoma
- Stage II, III, or locally recurrent disease
- Histologically confirmed locally advanced gastric adenocarcinoma
- T3, T4, or node positive OR locally recurrent disease
- Histologically confirmed locally advanced duodenal cancer
- Stage II or III disease
- Locally advanced, but unresectable cancers may be included on protocol if appropriate
for intraoperative radiotherapy (IORT)
- Other histologies may be considered for this protocol except for lymphoma, sarcoma,
or neuroendocrine tumors
- Patients with evidence of metastatic disease are eligible if there is significant
local disease warranting surgery and IORT
PATIENT CHARACTERISTICS:
- Karnofsky performance status > 60%
- Life expectancy > 4 months
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Serum creatinine < 2.0 mg/dL
- ALT < 3 x normal
- Bilirubin < 2 x normal
- Must be able to give voluntary informed consent
- No severe intercurrent illness that would make the patient inappropriate for
laparotomy or otherwise inappropriate for treatment on protocol
- Prior history of malignancy allowed
PRIOR CONCURRENT THERAPY:
- More than 4 weeks since prior chemotherapy (6 weeks for mitomycin C)
- Prior gemcitabine hydrochloride allowed
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Extrahepatic Bile Duct Cancer
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Gallbladder Cancer
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Gastric Cancer
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Pancreatic Cancer
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Small Intestine Cancer
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Intervention(s)
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Drug: gemcitabine hydrochloride
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Genetic: polymerase chain reaction
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Other: immunohistochemistry staining method
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Procedure: conventional surgery
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Radiation: intraoperative radiation therapy
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Radiation: radiation therapy
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Primary Outcome(s)
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Feasibility
[Time Frame: No]
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Measurement of biochemical parameters in tumors that may correlate with the effectiveness of therapy
[Time Frame: No]
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Tolerance
[Time Frame: Yes]
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Secondary ID(s)
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97087
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CHNMC-97087
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P30CA033572
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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