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

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal carcinoma, metastasis, capecitabine

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.

Jiaqi Han, Xiaomeng Lan, Kun Tian, Xi Shen, Jinlan He et al. (6 authors)

Frontiers in Public Health2023-01-267 citations

10.3389/fpubh.2022.1086393

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

Guoying Liu, Wang‐Zhong Li, De‐Shen Wang, Hu L, Xing Lv et al. (17 authors)

JAMA Oncology2022-02-1746 citations

10.1001/jamaoncol.2021.7366

Capecitabine maintenance therapy after induction chemotherapy in newly diagnosed metastatic nasopharyngeal carcinoma: An open-label, randomized, controlled, phase trial.

Guoying Liu, Wang‐Zhong Li, De‐Shen Wang, Hu L, Xing Lv et al. (20 authors)

Journal of Clinical Oncology2021-05-205 citations

10.1200/jco.2021.39.15_suppl.6044

Interventions

DRUGcapecitabine

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

OTHERBest supportive care (BSC)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
progression-free survival	up to 6 years	the time from randomization to the progression of disease

Secondary

Measure	Time frame	Description
overall survival	up to 6 years	the time from randomization to death
duration of response	up to 6 years	the time from the date of the first cycle of chemotherapy to the progression of disease
objective response rate	up to 6 years	CR, PR and SD rate
adverse effects	up to 6 years	chemotherapy side effects
quality of life of the patients during the Maintenance Capecitabine and/or Best Supportive Care	up to 6 years	evaluate with FACT-H&N every 3 months after randomiztion

Countries

China

Outcome results

None listed