Clinical trial NCT02460419: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal carcinoma
metastasis
capecitabine
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
name: Affiliated Cancer Hospital of Shantou University Medical College
First posted: 2015-06-02
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: progression-free survival
timeFrame: up to 6 years
Secondary outcomes:
measure: overall survival
timeFrame: up to 6 years
measure: duration of response
timeFrame: up to 6 years
measure: objective response rate
timeFrame: up to 6 years
measure: adverse effects
timeFrame: up to 6 years
measure: quality of life of the patients during the Maintenance Capecitabine and/or Best Supportive Care
timeFrame: up to 6 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: SunYat-senU
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Xiang Guo, MD
role: STUDY_CHAIR
References:
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.
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.
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.
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.