A Clinical Trial of Chemotherapy With Lobaplatin and 5-FU in Recurrent Local or Distant Advanced NPC.
NCT ID: NCT03210389
Last Updated: 2017-07-06
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
60 participants
INTERVENTIONAL
2017-07-31
2021-12-31
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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lobaplatin+5-FU
Patients enrolled in this trial would get 4-6 cycles of lobaplatin + 5-FU chemotherapy.
Lobaplatin
Patients enrolled will receive lobaplatin 30mg/m2 d1+ 5-FU 0.5g/m2/d d2-5 in every 21days. 4-6 cycles of chemotherapy are recommended.
Interventions
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Lobaplatin
Patients enrolled will receive lobaplatin 30mg/m2 d1+ 5-FU 0.5g/m2/d d2-5 in every 21days. 4-6 cycles of chemotherapy are recommended.
Eligibility Criteria
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Inclusion Criteria
* Recurrent locally or distant advanced NPC (rT3-4N0-3M0-1)
* ECOG 0 or 1
* Expected survival ≥ 1 year
* Without dysfunction of heart, lung, liver, kidney and hematopoiesis
* Patients are voluntary and signed informed consent
* No other anti-tumor treatment (including steroid)
Exclusion Criteria
* Use of 5-FU in last 6 months
* Had major surgery in last 4 weeks, or the wound has not completely healed
* Toxicity from previous treatment is still ≥CTC AE grade 3
* History of other carcinoma in the past 5 years, except for treated carcinoma in situ of cervix, as well as basal cell carcinoma or squamous cell carcinoma of the skin
* Dysfunction of heart
* Bleeding ≥CTC AE grade 3
* Use of anticoagulant or vitamin K antagonists, except for small dose of aspirin and warfarin for prevention
* Patients participated in clinical trials of other drugs within last 4 weeks
* Mental illness
18 Years
70 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Yun-fei Xia
Director of Department of Radiation Oncology, Principal Investigator, Clinical Professor
Principal Investigators
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Yun-fei Xia, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
Locations
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Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Other Identifiers
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B2016-001-01
Identifier Type: -
Identifier Source: org_study_id
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