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

Primary Purpose

Nasopharyngeal Carcinoma

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
capecitabine
Best supportive care (BSC)
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal carcinoma, metastasis, capecitabine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SunYat-senU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

maintenance capecitabine

best supportive care

Arm Description

maintenance capecitabine plus best supportive care(BSC)

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

Outcomes

Primary Outcome Measures

progression-free survival
the time from randomization to the progression of disease

Secondary Outcome Measures

overall survival
the time from randomization to death
duration of response
the time from the date of the first cycle of chemotherapy to the progression of disease
objective response rate
CR, PR and SD rate
adverse effects
chemotherapy side effects
quality of life of the patients during the Maintenance Capecitabine and/or Best Supportive Care
evaluate with FACT-H&N every 3 months after randomiztion

Full Information

First Posted
May 23, 2015
Last Updated
October 27, 2022
Sponsor
Sun Yat-sen University
Collaborators
Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Affiliated Cancer Hospital of Shantou University Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT02460419
Brief Title
Maintenance Capecitabine Plus Best Supportive Care Versus Best Supportive Care for Metastatic Nasopharyngeal Carcinoma
Official Title
Maintenance Capecitabine Plus Best Supportive Care Versus Best Supportive Care for Metastatic Nasopharyngeal Carcinoma: a Multicenter, Randomised, Phase 3 Study.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
May 2020 (Actual)
Study Completion Date
May 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Affiliated Cancer Hospital of Shantou University Medical College

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Nasopharyngeal carcinoma, metastasis, capecitabine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
maintenance capecitabine
Arm Type
Experimental
Arm Description
maintenance capecitabine plus best supportive care(BSC)
Arm Title
best supportive care
Arm Type
Other
Arm Description
Best supportive care and following-up every 6-8 weeks
Intervention Type
Drug
Intervention Name(s)
capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
capecitabine 1250mg/m2 bid, oral, for 14 days, every 3 weeks. Number of Cycles: until progression or unacceptable toxicity develops.
Intervention Type
Other
Intervention Name(s)
Best supportive care (BSC)
Intervention Description
Best supportive care and following-up every 6-8 weeks
Primary Outcome Measure Information:
Title
progression-free survival
Description
the time from randomization to the progression of disease
Time Frame
up to 6 years
Secondary Outcome Measure Information:
Title
overall survival
Description
the time from randomization to death
Time Frame
up to 6 years
Title
duration of response
Description
the time from the date of the first cycle of chemotherapy to the progression of disease
Time Frame
up to 6 years
Title
objective response rate
Description
CR, PR and SD rate
Time Frame
up to 6 years
Title
adverse effects
Description
chemotherapy side effects
Time Frame
up to 6 years
Title
quality of life of the patients during the Maintenance Capecitabine and/or Best Supportive Care
Description
evaluate with FACT-H&N every 3 months after randomiztion
Time Frame
up to 6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiang Guo, MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
SunYat-senU
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
22684794
Citation
Jin Y, Shi YX, Cai XY, Xia XY, Cai YC, Cao Y, Zhang WD, Hu WH, Jiang WQ. Comparison of five cisplatin-based regimens frequently used as the first-line protocols in metastatic nasopharyngeal carcinoma. J Cancer Res Clin Oncol. 2012 Oct;138(10):1717-25. doi: 10.1007/s00432-012-1219-x. Epub 2012 Jun 10. Erratum In: J Cancer Res Clin Oncol. 2015 Apr;141(4):767.
Results Reference
background
PubMed Identifier
22076785
Citation
Chua DT, Yiu HH, Seetalarom K, Ng AW, Kurnianda J, Shotelersuk K, Krishnan G, Hong RL, Yang MH, Wang CH, Sze WK, Ng WT. Phase II trial of capecitabine plus cisplatin as first-line therapy in patients with metastatic nasopharyngeal cancer. Head Neck. 2012 Sep;34(9):1225-30. doi: 10.1002/hed.21884. Epub 2011 Nov 11.
Results Reference
background
PubMed Identifier
18615622
Citation
Leong SS, Wee J, Rajan S, Toh CK, Lim WT, Hee SW, Tay MH, Poon D, Tan EH. Triplet combination of gemcitabine, paclitaxel, and carboplatin followed by maintenance 5-fluorouracil and folinic acid in patients with metastatic nasopharyngeal carcinoma. Cancer. 2008 Sep 15;113(6):1332-7. doi: 10.1002/cncr.23687.
Results Reference
background
PubMed Identifier
35175316
Citation
Liu GY, Li WZ, Wang DS, Liang H, Lv X, Ye YF, Zhao C, Ke LR, Lv SH, Lu N, Bei WX, Cai ZC, Chen X, Liang CX, Guo X, Xia WX, Xiang YQ. Effect of Capecitabine Maintenance Therapy Plus Best Supportive Care vs Best Supportive Care Alone on Progression-Free Survival Among Patients With Newly Diagnosed Metastatic Nasopharyngeal Carcinoma Who Had Received Induction Chemotherapy: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2022 Apr 1;8(4):553-561. doi: 10.1001/jamaoncol.2021.7366.
Results Reference
derived

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

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