About this trial
The Children and Adolescents Nasopharyngeal Carcinoma Survivor Study will investigate the long-term effects of nasopharyngeal carcinoma (NPC) and its associated therapies. A prospective and retrospective cohort study will be conducted through a multi-institutional collaboration. This project will study children and adolescents exposed to specific therapeutic modalities, including radiation, chemotherapy, and/or surgery, who are at increased risk of late-occurring adverse health outcomes. A group of sibling controls will be identified and data collected for comparison purposes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients or their siblings must be informed of the investigational nature of this study and give written informed consent.
Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma (including differentiated type and undifferentiated type, WHO II or III) before age 21 years at one of participating centers.
Disqualifiers
Already involved in other blind clinical trial.
The information of tumour response evaluation and survival data cannot be obtained.
Trial population
NPC patients under 21 years old and their siblings
Trial design
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Overall survival(OS)
The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.
Secondary outcomes
Progress-free survival(PFS)
Progress-free survival is calculated from the date of randomization to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up
Locoregional failure-free survival(LRFS)
The LRFS is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit
Distant metastasis-free survival(DMFS)
The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit
Short-term toxic effects assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)
The shortterm toxic effects were assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)
Other outcomes
Long-term toxicities
QoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30)
Long-term toxicities
EORTC quality of life questionnaire(QLQ) Head and Neck
Long-term toxicities
Late Effects Normal Tissue Task Force-Subjective, Objective, Management and Analytic (LENT-SOMA) scoring systems
Growth
Patients will be monitored for height(in metre)
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hai-Qiang Mai,MD,PhD
Lead sponsor
Sun Yat-sen University
Sponsor institution
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Collaborator
Guangdong Provincial People's Hospital
Collaborator
First Affiliated Hospital of Jinan University
Collaborator
Nanfang Hospital, Southern Medical University
Collaborator
Affiliated Cancer Hospital of Shantou University Medical College
Collaborator
Zhanjiang Cancer Hospital
Collaborator
Zhongnan Hospital
Collaborator
First People's Hospital of Foshan
Collaborator
Dongguan People's Hospital
Collaborator
Fifth Affiliated Hospital, Sun Yat-Sen University
Collaborator
Shenzhen Second People's Hospital
Collaborator
Jiangmen Central Hospital
Collaborator
Yuebei People's Hospital
Collaborator
Hunan Cancer Hospital
Collaborator
Cancer Hospital of Guizhou Province
Collaborator
Fudan University
Collaborator
Fujian Cancer Hospital
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Zhejiang Cancer Hospital
Collaborator
Sichuan Cancer Hospital and Research Institute
Collaborator
Shandong Cancer Hospital and Institute
Collaborator
Jiangsu Cancer Institute & Hospital
Collaborator
Jiangxi Provincial Cancer Hospital
Collaborator
Second Affiliated Hospital of Nanchang University
Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborator
Peking University Cancer Hospital & Institute
Collaborator
Cancer Hospital of Guangxi Medical University
Collaborator
Tongji Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options: