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A Clinical Trial of Chemotherapy With Lobaplatin and 5-FU in Recurrent Local or Distant Advanced NPC.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03210389
Recruitment Status : Unknown
Verified July 2017 by Yun-fei Xia, Sun Yat-sen University.
Recruitment status was:  Not yet recruiting
First Posted : July 6, 2017
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):
Yun-fei Xia, Sun Yat-sen University

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of chemotherapy with Lobaplatin and 5-FU, in Recurrent Local or Distant Advanced Nasopharyngeal Carcinoma.

Condition or disease Intervention/treatment Phase
Recurrent Nasopharyngeal Carcinoma Drug: Lobaplatin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Single-arm, and Open Clinical Trial of Chemotherapy With Lobaplatin and 5-FU on Efficacy and Safety in Recurrent Local or Distant Advanced NPC.
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: lobaplatin+5-FU
Patients enrolled in this trial would get 4-6 cycles of lobaplatin + 5-FU chemotherapy.
 Drug: 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.


Outcome Measures
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Primary Outcome Measures :
  1. progression-free survival [ Time Frame: 2 years after chemotherapy ]
    the time from randomization to death or disease progression


Secondary Outcome Measures :
  1. overall survival [ Time Frame: 2 years after chemotherapy ]
    the time from randomization to death of any cause

  2. objective response rate [ Time Frame: 2 years after chemotherapy ]
    the ratio that patients who get PR or CR in all the patients


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • NPC diagnosed by pathology, with measurable lesions and imaging results, such as MRI and CT. Patients with no other lesions but bone metastasis are excluded.
  • 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:

  • Allergy history to platinum
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210389


Contacts
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Contact: Yun-fei Xia, Professor 86-13602805461 xiayf@sysucc.org.cn
Contact: Xiaohui Wang, MD 86-18826260661 wangxh@sysucc.org.cn

Locations
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China, Guangdong
Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Yun-fei Xia, Professor Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
More Information
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Responsible Party: Yun-fei Xia, Director of Department of Radiation Oncology, Principal Investigator, Clinical Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03210389    
Other Study ID Numbers: B2016-001-01
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yun-fei Xia, Sun Yat-sen University:
Recurrent Nasopharyngeal Carcinoma
lobaptin
Additional relevant MeSH terms:
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Nasopharyngeal Carcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
 Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases