The Children and Adolescents Nasopharyngeal Carcinoma Survivor Study

ConditionNPC Patients
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 21
SponsorHai-Qiang Mai,MD,PhD

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 2 trial groups
Group A: NPC survivors
Group B: Sibling Controls

Trial outcomes

Primary outcomes

1

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.

Time frame
5 years

Secondary outcomes

1

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

Time frame
5 years
2

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

Time frame
5 years
3

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

Time frame
5 years
4

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)

Time frame
3 months

Other outcomes

1

Long-term toxicities

QoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30)

Time frame
Through study completion, an average of half year
2

Long-term toxicities

EORTC quality of life questionnaire(QLQ) Head and Neck

Time frame
Through study completion, an average of half year
3

Long-term toxicities

Late Effects Normal Tissue Task Force-Subjective, Objective, Management and Analytic (LENT-SOMA) scoring systems

Time frame
Through study completion, an average of half year
4

Growth

Patients will be monitored for height(in metre)

Time frame
Through study completion, an average of half year

Locations

This trial has no 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: