Clinical trial · Interventional
Maintenance Capecitabine Plus Best Supportive Care Versus Best Supportive Care for Metastatic Nasopharyngeal Carcinoma
Maintenance Capecitabine Plus Best Supportive Care Versus Best Supportive Care for Metastatic Nasopharyngeal Carcinoma: a Multicenter, Randomised, Phase 3 Study.
NCT02460419CI-TRIAL-00061776completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best supportive care (BSC) | Other | — | UNRESOLVED |
| capecitabine | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- maintenance capecitabine
- description
- maintenance capecitabine plus best supportive care(BSC)
- interventionNames
- Drug: capecitabine
- Other: Best supportive care (BSC)
- type
- OTHER
- label
- best supportive care
- description
- Best supportive care and following-up every 6-8 weeks
- interventionNames
- Other: Best supportive care (BSC)
Primary outcomes (1)
- measure
- progression-free survival
- timeFrame
- up to 6 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDJin 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 22684794
- BACKGROUNDChua 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 22076785
- BACKGROUNDLeong 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 18615622
- DERIVEDHan 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 36777769
- DERIVEDLiu 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 35175316