Trial Evaluating Maintenance Chemotherapy for Metastatic Nasopharyngeal Carcinoma

• Status: Unknown status
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Proton and Heavy Ion Center
• Collaborators: 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

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