Clinical trial NCT02944708: Trial Evaluating Maintenance Chemotherapy for Metastatic Nasopharyngeal Carcinoma
Official title: A Randomized Phase III Trial Evaluating Maintenance Chemotherapy for Metastatic Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Keywords: maintenance chemotherapy
Lead sponsor: Shanghai Proton and Heavy Ion Center
Sponsor class: OTHER
Collaborators: name: Fudan University
name: Eye & ENT Hospital of Fudan University
name: The First Affiliated Hospital of Xiamen University
name: Jiangxi Provincial Cancer Hospital
name: Taichung Veterans General Hospital
name: First Affiliated Hospital of Fujian Medical University
name: Cancer Hospital of Guangxi Medical University
name: National Cancer Centre, Singapore
name: West China Hospital
name: Peking University Cancer Hospital & Institute
name: Tongji Hospital
name: People's Hospital of Guangxi Zhuang Autonomous Region
First posted: 2016-10-26
Enrollment: 384
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: The purpose of this study is to examine the efficacy of maintenance chemotherapy for the treatment of metastatic nasopharyngeal carcinoma. Participants will be randomized to 3 arms. Arm 1, control group, participants will receive only 4-8 cycles of conventional chemotherapy; arm 2, participants will receive 6 cycles of maintenance chemotherapy after conventional chemotherapy; arm 3, experiment arm, after conventional chemotherapy, participants will receive maintenance chemotherapy until disease progression or intolerable toxicities.

Detailed description: This is a phase 3 randomized clinical trial to determine the efficacy of maintenance chemotherapy for the treatment of metastatic chemotherapy and how it should be delivered. Participants will be randomized to 3 arms. Arm 1 (control group), participants will receive only conventional chemotherapy; arm 2 (experimental group), participants will receive up to 6 cycles of maintenance chemotherapy after conventional chemotherapy; arm 3 (experimental group), after conventional chemotherapy, participants will receive maintenance chemotherapy until disease progression or intolerable toxicities. Participants in all 3 arms will receive similar conventional chemotherapy. Four to eight cycles of conventional chemotherapy with platinum-based regimen is preferred. Maintenance chemotherapy should use one of the regimens: S1 (40mg, twice a day for 14 days, every 3 weeks), capecitabine (1000mg/m\^2, twice a day for 14 days, every 3 weeks) or Tegafur-uracil (100mg/m\^2, q8h, for 14 days, every 3 weeks). The response of treatment will be evaluated according to RECIST criteria. Adverse events will be documented according to CTCAE v4.03.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 and ≤ 70 years
* Histologically confirmed nasopharyngeal carcinoma, WHO (World Health Organization) classification II/III
* With distant metastasis
* With measurable lesions that can be detected by imaging studies
* Achieving PR (partial response) after 4 cycles of conventional chemotherapy
* Life expectancy ≥ 6 months
* ECOG (Eastern Cooperative Oncology Group): 0-1, no significant active concurrent medical illnesses
* Adequate laboratory values within 30 dyas of enrollment to study defined as follows: N \> 2000/mm\^3; PLT (platelet count) \> 100,000/mm\^3; total bilirubin \< 1.5mg/dl; AST (aspartate aminotransferase)/ALT (alanine aminotransferase) \< 1.5 ULN (upper limit of normal); SCr (serum creatinine) \< 1.5mg/dl; CCR (creatinine clearance rate) \> 60ml/min
* Willing to accept adequate contraception for women with childbearing potential
* Ability to understand character and individual consequences of the clinical trial
* Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial

Exclusion Criteria:

* Received previous treatment for metastatic disease
* Pregnant or lactating women
* A diagnosis of malignancy other than CIS (carcinoma in situ) of the cervix, BCC (basal cell carcinoma) and SCC (squamous cell carcinoma) of the skin within the past 5 years
* Refusal of the patient to participate into the study

Primary outcomes:
measure: Progression-free survival
timeFrame: From the time point the patients are included in the study, median of 3 years.
Secondary outcomes:
measure: Overall survival
timeFrame: From the time point the patients are included in the study, median of 3 years.
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
timeFrame: From the time point the patients are included in the study, median of 3 years.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Nanning
country: China
facility: Cancer Hospital of Guangxi Medical University
state: Guangxi
city: Nanning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College of HUST
state: Hubei
city: Nanchang
country: China
facility: Jiangxi Province Tumor Hospital
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Provincial Cancer Hospital
state: Jiangxi
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer center
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Proton and Heavy Ion Center
state: Shanghai
city: Shanghai
country: China
facility: Eye & ENT Hospital of Fudan University
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
city: Singapore
country: Singapore
facility: National Cancer Centre, Singapore
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC
name: Jiade J Lu, MD
role: PRINCIPAL_INVESTIGATOR
References: