The Children and Adolescents Nasopharyngeal Carcinoma Survivor Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- NPC Patients
- Sponsor
- Hai-Qiang Mai,MD,PhD
- Enrollment
- 1000
- Primary Endpoint
- Overall survival(OS)
- Status
- Not yet recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Hai-Qiang Mai,MD,PhD
Hai-Qiang Mai
Sun Yat-sen University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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
- Progress-free survival(PFS)(5 years)
- Locoregional failure-free survival(LRFS)(5 years)
- Short-term toxic effects assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)(3 months)
- Distant metastasis-free survival(DMFS)(5 years)