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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02460419
• Other study ID #: 2015029
• Status: Completed
• Phase: Phase 3
• Start date: April 2015
• Est. completion date: May 2020

Study information

• Verified date: October 2022
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

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

Other:
• Best supportive care (BSC)
Best supportive care and following-up every 6-8 weeks

Locations

Country	Name	City	State
China	SunYat-senU	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Sun Yat-sen University	Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Affiliated Cancer Hospital of Shantou University Medical College

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. Epub 2012 Jun 10. Erratum in: J Cancer Res Clin Oncol. 2015 Apr;141(4):767. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival	the time from randomization to the progression of disease	up to 6 years
Secondary	overall survival	the time from randomization to death	up to 6 years
Secondary	duration of response	the time from the date of the first cycle of chemotherapy to the progression of disease	up to 6 years
Secondary	objective response rate	CR, PR and SD rate	up to 6 years
Secondary	adverse effects	chemotherapy side effects	up to 6 years
Secondary	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	up to 6 years