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

October 27, 2022 updated by: XIANG YANQUN, Sun Yat-sen University

Maintenance Capecitabine Plus Best Supportive Care Versus Best Supportive Care for Metastatic Nasopharyngeal Carcinoma: a Multicenter, Randomised, Phase 3 Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • SunYat-senU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Xeloda
Other: Best supportive care (BSC)
Best supportive care and following-up every 6-8 weeks
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free survival
Time Frame: up to 6 years
the time from randomization to the progression of disease
up to 6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: up to 6 years
the time from randomization to death
up to 6 years
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
up to 6 years
objective response rate
Time Frame: up to 6 years
CR, PR and SD rate
up to 6 years
adverse effects
Time Frame: up to 6 years
chemotherapy side effects
up to 6 years
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
up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

Affiliated Cancer Hospital of Shantou University Medical College
Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Investigators

  • Study Chair: Xiang Guo, MD, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

May 23, 2015

First Submitted That Met QC Criteria

May 29, 2015

First Posted (Estimate)

June 2, 2015

Study Record Updates

Last Update Posted (Actual)

October 28, 2022

Last Update Submitted That Met QC Criteria

October 27, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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