Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2015-05-31
2018-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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POLF regimen
Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly
Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly
metronomic chemotherapy
Interventions
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Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly
metronomic chemotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. measurable disease based on CT or endoscopy exam
3. non-surgical candidates or patients who declined surgery
4. non-radiation candidates or patients who declined radiation
5. patients who are able to sign informed consent
6. patients who are 2 weeks out and recovered from surgery
7. patients who have completed radiation to relieve obstructive symptoms
8. patient who previously received Oxaliplatin and 5-FU in other MTD regimens
9. adequate marrow function: neutrophil \>1000/ul, Hgb \>10g/dl, Plt\>50,000
Exclusion Criteria
2. concurrent malignancies
3. severe co-morbidities of heart, lungs, kidneys and bone marrow
4. severe psychological disorder
5. severe malnutrition
6. difficult to heal or unhealed wound
7. ECOG performance status equal or over 3
8. uncontrolled complications from the malignancy
9. uncontrolled CNS metastasis
10. peripheral neuropathy grade 3 or above
11. pregnancy or breast feeding
18 Years
70 Years
ALL
No
Sponsors
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Seattle Integrative Cancer Center
UNKNOWN
Huashan Hospital
OTHER
Responsible Party
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Nick Chen
Visiting Professor
Principal Investigators
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Jie Liu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Huashan Hospital
Nick N Chen, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seattle Integrative Cancer Center
Jun Zhang, M.D.
Role: STUDY_DIRECTOR
Huashan Hospital
Zhongguang Luo, M.D.
Role: STUDY_DIRECTOR
Huashan Hospital
Locations
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Seattle Integrative Cancer Center
Seattle, Washington, United States
Huashan Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KY2016-206
Identifier Type: -
Identifier Source: org_study_id
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