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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02944708
Other study ID # SPHIC-TR-HNCNS-2015-04
Secondary ID
Status Recruiting
Phase Phase 3
First received October 24, 2016
Last updated October 26, 2016
Start date October 2015
Est. completion date October 2018

Study information

Verified date October 2016
Source Shanghai Proton and Heavy Ion Center
Contact Lin Kong, MD
Email lin.kong@sphic.org.cn
Is FDA regulated No
Health authority China: Shanghai Municipal Commission of Health and Family Planning
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 384
Est. completion date October 2018
Est. primary completion date October 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Conventional chemotherapy

Maintenance chemotherapy 1

Maintenance chemotherapy 2


Locations

Country Name City State
China Peking University Cancer Hospital Beijing Beijing
China West China Hospital Chengdu Sichuan
China The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian
China Jiangxi Province Tumor Hospital Nanchang Jiangxi
China Jiangxi Provincial Cancer Hospital Nanchang Jiangxi
China Cancer Hospital of Guangxi Medical University Nanning Guangxi
China The People's Hospital of Guangxi Zhuang Autonomous Region Nanning Guangxi
China Eye & ENT Hospital of Fudan University Shanghai Shanghai
China Fudan University Shanghai Cancer center Shanghai Shanghai
China Shanghai Proton and Heavy Ion Center Shanghai Shanghai
China Tongji Hospital, Tongji Medical College of HUST Wuhan Hubei
China The First Affiliated Hospital of Xiamen University Xiamen Fujian
Singapore National Cancer Centre, Singapore Singapore
Taiwan Taichung Veterans General Hospital Taichung

Sponsors (13)

Lead Sponsor Collaborator
Shanghai Proton and Heavy Ion Center Beijing Cancer Hospital, Cancer Hospital of Guangxi Medical University, Eye & Ent Hospital of Fudan University, First Affiliated Hospital of Fujian Medical University, Fudan University, Jiangxi Provincial Cancer Hospital, National Cancer Centre, Singapore, People's Hospital of Guangxi, Taichung Veterans General Hospital, The First Affiliated Hospital of Xiamen University, Tongji Hospital, West China Hospital

Countries where clinical trial is conducted

China,  Singapore,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free survival From the time point the patients are included in the study, median of 3 years. Yes
Secondary Overall survival From the time point the patients are included in the study, median of 3 years. Yes
Secondary Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 From the time point the patients are included in the study, median of 3 years. Yes
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