Trial Evaluating Maintenance Chemotherapy for Metastatic Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

A Randomized Phase III Trial Evaluating Maintenance Chemotherapy for Metastatic Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02944708
• Other study ID #: SPHIC-TR-HNCNS-2015-04
• 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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

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