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Maintenance Capecitabine Plus Best Supportive Care Versus Best Supportive Care for Metastatic Nasopharyngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT02460419
Recruitment Status : Recruiting
First Posted : June 2, 2015
Last Update Posted : September 6, 2018
Sponsor:
Collaborators:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Cancer Hospital of Shantou University
Information provided by (Responsible Party):
XIANG YANQUN, Sun Yat-sen University

Brief Summary:
This multicenter, randomised, phase 3 study is to evaluate the survival benefit of maintenance capecitabine plus best supportive care versus best supportive care for metastatic nasopharyngeal carcinoma patients after disease controlled with TPC palliative chemotherapy.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: capecitabine Other: Best supportive care (BSC) Phase 3

Detailed Description:
Firstly diagnosed metastatic nasopharyngeal carcinoma patients will receive 4-6 cycles of palliative chemotherapy with taxol,cisplatin and capecitabine. After disease controlled, they will be randomly assigned to maintenance capecitabine plus best supportive care(BSC) or BSC alone. The primary end point is progression-free survival, the secondary end points are overall survival, duration of response, objective response rate, adverse effects and quality of life.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Maintenance Capecitabine Plus Best Supportive Care Versus Best Supportive Care for Metastatic Nasopharyngeal Carcinoma: a Multicenter, Randomised, Phase 3 Study.
Study Start Date : April 2015
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: maintenance capecitabine
maintenance capecitabine plus best supportive care(BSC)
Drug: capecitabine
capecitabine 1250mg/m2 bid, oral, for 14 days, every 3 weeks. Number of Cycles: until progression or unacceptable toxicity develops.
Other Name: Xeloda

Other: Best supportive care (BSC)
Best supportive care and following-up every 6-8 weeks

best supportive care
Best supportive care and following-up every 6-8 weeks
Other: Best supportive care (BSC)
Best supportive care and following-up every 6-8 weeks




Primary Outcome Measures :
  1. progression-free survival [ Time Frame: up to 6 years ]
    the time from randomization to the progression of disease


Secondary Outcome Measures :
  1. overall survival [ Time Frame: up to 6 years ]
    the time from randomization to death

  2. duration of response [ Time Frame: up to 6 years ]
    the time from the date of the first cycle of chemotherapy to the progression of disease

  3. objective response rate [ Time Frame: up to 6 years ]
    CR, PR and SD rate

  4. adverse effects [ Time Frame: up to 6 years ]
    chemotherapy side effects

  5. quality of life of the patients during the Maintenance Capecitabine and/or Best Supportive Care [ Time Frame: up to 6 years ]
    evaluate with FACT-H&N every 3 months after randomiztion



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Firstly diagnosed metastatic nasopharyngeal carcinoma patients
  • Disease controlled after 4-6 cycles of palliative chemotherapy with taxol,cisplatin and capecitabine
  • Eastern Cooperative Oncology Group (ECOG) 0-2
  • Life expectation at least 12 weeks
  • No systemic chemotherapy within 6 months, except for induction chemotherapy or concurrent chemotherapy
  • With at least one measurable lesion
  • Enough blood test
  • Signed informed consent

Exclusion Criteria:

  • Sever heart disease
  • HIV infection
  • Sever infection
  • Brain metastasis, except received radical therapy 6 months ago and stable in 4 weeks
  • Allogeneic organ transplantation
  • Malignancy other than nasopharyngeal carcinoma, except:cervical carcinoma in situ, cured basal cell carcinoma,bladder cancer of Ta,Tis or T1, or any cured cancer for at least 3 years
  • Pregnancy or breast feeding
  • Difficulty in swallowing
  • Received other test drugs

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): NCT02460419


Contacts
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Contact: Weixiong Xia, MD 86-20-87343379 xiawx@sysucc.org.cn
Contact: Xing Lv, MD 86-20-87343359 lvxing@sysucc.org.cn

Locations
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China, Guangdong
SunYat-senU Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Weixiong Xia, MD    86-20-87343380    xiawx@sysucc.org.cn   
Contact: Xing Lv    86-20-87343636    lvxing@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Cancer Hospital of Shantou University
Investigators
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Study Chair: Xiang Guo, MD Sun Yat-sen University

Publications:
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Responsible Party: XIANG YANQUN, MD,PhD, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02460419     History of Changes
Other Study ID Numbers: 2015029
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Keywords provided by XIANG YANQUN, Sun Yat-sen University:
Nasopharyngeal carcinoma
metastasis
capecitabine
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal 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
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents