Maintenance Capecitabine Plus Best Supportive Care Versus Best Supportive Care for Metastatic Nasopharyngeal Carcinoma
1 other identifier
interventional
104
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2015
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 23, 2015
CompletedFirst Posted
Study publicly available on registry
June 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedOctober 28, 2022
October 1, 2022
5.1 years
May 23, 2015
October 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
progression-free survival
the time from randomization to the progression of disease
up to 6 years
Secondary Outcomes (5)
overall survival
up to 6 years
duration of response
up to 6 years
objective response rate
up to 6 years
adverse effects
up to 6 years
quality of life of the patients during the Maintenance Capecitabine and/or Best Supportive Care
up to 6 years
Study Arms (2)
maintenance capecitabine
EXPERIMENTALmaintenance capecitabine plus best supportive care(BSC)
best supportive care
OTHERBest supportive care and following-up every 6-8 weeks
Interventions
capecitabine 1250mg/m2 bid, oral, for 14 days, every 3 weeks. Number of Cycles: until progression or unacceptable toxicity develops.
Best supportive care and following-up every 6-8 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SunYat-senU
Guangzhou, Guangdong, 510060, China
Related Publications (5)
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.
PMID: 22684794BACKGROUNDChua 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.
PMID: 22076785BACKGROUNDLeong 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.
PMID: 18615622BACKGROUNDHan J, Lan X, Tian K, Shen X, He J, Chen N. Cost-effectiveness analysis of capecitabine maintenance therapy plus best supportive care vs. best supportive care alone as first-line treatment of newly diagnosed metastatic nasopharyngeal carcinoma. Front Public Health. 2023 Jan 26;10:1086393. doi: 10.3389/fpubh.2022.1086393. eCollection 2022.
PMID: 36777769DERIVEDLiu 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.
PMID: 35175316DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Xiang Guo, MD
Sun Yat-sen University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD,PhD
Study Record Dates
First Submitted
May 23, 2015
First Posted
June 2, 2015
Study Start
April 1, 2015
Primary Completion
May 1, 2020
Study Completion
May 1, 2020
Last Updated
October 28, 2022
Record last verified: 2022-10