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NCT Number: NCT03637634

The Children and Adolescents Nasopharyngeal Carcinoma Survivor Study

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.

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Key information

Conditions

NPC Patients

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

About this study

The study will focus on the following objectives:

  • Characterize survivors' health with respect to disease- and treatment-related factors.
  • Investigate the consequences of various intensities of exposure to chemotherapy and/or radiation on health outcomes (e.g., cardiovascular, reproductive, second cancers, etc…).
  • Compare the mortality experience of survivors with the general population.
  • Characterize the health-related behaviors, patterns of medical care, and medical follow-up needs of survivors.
  • Describe patterns of familial aggregation of cancer, including known (and variations of) cancer family syndromes.
  • Collect and store biologic samples (saliva, blood, second tumor tissue) to correlate with health outcomes and use for future research.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Already involved in other blind clinical trial.
  • The information of tumour response evaluation and survival data cannot be obtained.

Treatment and study plan

Primary outcomes

  1. Overall survival(OS)

    Time frame: 5 years

    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

  1. Progress-free survival(PFS)

    Time frame: 5 years

    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

  2. Locoregional failure-free survival(LRFS)

    Time frame: 5 years

    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

  3. Distant metastasis-free survival(DMFS)

    Time frame: 5 years

    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

  4. Short-term toxic effects assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)

    Time frame: 3 months

    The shortterm toxic effects were assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)

Other outcomes

  1. Long-term toxicities

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

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

  2. Long-term toxicities

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

    EORTC quality of life questionnaire(QLQ) Head and Neck

  3. Long-term toxicities

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

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

  4. Growth

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

    Patients will be monitored for height(in metre)

  5. Growth

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

    Patients will be monitored for weight(in kilogram)

  6. Growth

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

    Patients will be monitored for BMI(in kg/m^2)

  7. Sex Development

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

    secondary sex characteristic survey

  8. Sex Development

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

    sex hormone(estrogen,testosterone) levels(in nmol/L).

  9. Intelligence Development

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

    Intelligence quotient by Stanford-Binet test

Study contacts

Contact information is provided by the study sponsor or research team.

Haiqiang Mai, Dr

CONTACT

[email protected]

86-20-8734-3643

Sponsors and collaborators

Lead sponsor

Hai-Qiang Mai,MD,PhD

Other

Collaborators

  • Affiliated Cancer Hospital & Institute of Guangzhou Medical University
  • Affiliated Cancer Hospital of Shantou University Medical College
  • Cancer Hospital of Guangxi Medical University
  • Cancer Hospital of Guizhou Province
  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Dongguan People's Hospital
  • Fifth Affiliated Hospital, Sun Yat-Sen University
  • First Affiliated Hospital of Jinan University
  • First People's Hospital of Foshan
  • Fudan University
  • Fujian Cancer Hospital
  • Guangdong Provincial People's Hospital
  • Hunan Cancer Hospital
  • Jiangmen Central Hospital
  • Jiangsu Cancer Institute & Hospital
  • Jiangxi Provincial Cancer Hospital
  • Nanfang Hospital, Southern Medical University
  • Peking University Cancer Hospital & Institute
  • Second Affiliated Hospital of Nanchang University
  • Shandong Cancer Hospital and Institute
  • Shenzhen Second People's Hospital
  • Sichuan Cancer Hospital and Research Institute
  • The First Affiliated Hospital of Zhengzhou University
  • Tongji Hospital
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Yuebei People's Hospital
  • Zhanjiang Cancer Hospital
  • Zhejiang Cancer Hospital
  • Zhongnan Hospital

Registry information

Acronym: CANPCSS

Important dates

Study start
2018
Primary completion
2030
Study completion
2035
First posted
Aug 20, 2018
Registry last updated
Aug 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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