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NCT Number: NCT02460419

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

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.

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Key information

Conditions

Nasopharyngeal Carcinoma Carcinoma Head and Neck Neoplasms Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Processes Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

SunYat-senU

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capecitabine

Drug

capecitabine 1250mg/m2 bid, oral, for 14 days, every 3 weeks. Number of Cycles: until progression or unacceptable toxicity develops.

Other names: Xeloda

Best Supportive Care (BSC)

Other

Best supportive care and following-up every 6-8 weeks

Primary outcomes

  1. progression-free survival

    Time frame: up to 6 years

    the time from randomization to the progression of disease

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Jun 2, 2015
Registry last updated
Oct 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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