NPC Patients Clinical Trial
— CANPCSSOfficial title:
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.
| Status | Not yet recruiting |
| Enrollment | 1000 |
| Est. completion date | December 31, 2035 |
| Est. primary completion date | December 31, 2030 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A to 21 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hai-Qiang Mai,MD,PhD | Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Affiliated Zhongshan Hospital, Sun Yat-Sen University, Beijing Cancer Hospital, Cancer Hospital of Guangxi Medical University, Cancer Hospital of Guizhou Province, Cancer Hospital of Shantou University, 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 of Southern Medical University, 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, Wuhan Union Hospital, China, Yuebei People's Hospital, Zhanjiang Cancer Hospital, Zhejiang Cancer Hospital |
Downing NL, Wolden S, Wong P, Petrik DW, Hara W, Le QT. Comparison of treatment results between adult and juvenile nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2009 Nov 15;75(4):1064-70. doi: 10.1016/j.ijrobp.2008.12.030. Epub 2009 Mar 26. — View Citation
Ingersoll L, Woo SY, Donaldson S, Giesler J, Maor MH, Goffinet D, Cangir A, Goepfert H, Oswald MJ, Peters LJ. Nasopharyngeal carcinoma in the young: a combined M.D. Anderson and Stanford experience. Int J Radiat Oncol Biol Phys. 1990 Oct;19(4):881-7. — View Citation
Levine PH, Connelly RR, Easton JM. Demographic patterns for nasopharyngeal carcinoma in the United States. Int J Cancer. 1980 Dec 15;26(6):741-8. — View Citation
Wei WI, Sham JS. Nasopharyngeal carcinoma. Lancet. 2005 Jun 11-17;365(9476):2041-54. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Long-term toxicities | QoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30) | Through study completion, an average of half year | |
| Other | Long-term toxicities | EORTC quality of life questionnaire(QLQ) Head and Neck | Through study completion, an average of half year | |
| Other | Long-term toxicities | Late Effects Normal Tissue Task Force-Subjective, Objective, Management and Analytic (LENT-SOMA) scoring systems | Through study completion, an average of half year | |
| Other | Growth | Patients will be monitored for height(in metre) | Through study completion, an average of half year | |
| Other | Growth | Patients will be monitored for weight(in kilogram) | Through study completion, an average of half year | |
| Other | Growth | Patients will be monitored for BMI(in kg/m^2) | Through study completion, an average of half year | |
| Other | Sex Development | secondary sex characteristic survey | Through study completion, an average of half year | |
| Other | Sex Development | sex hormone(estrogen,testosterone) levels(in nmol/L). | Through study completion, an average of half year | |
| Other | Intelligence Development | Intelligence quotient by Stanford-Binet test | Through study completion, an average of half year | |
| Primary | 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. | 5 years | |
| Secondary | 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 | 5 years | |
| Secondary | 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 | 5 years | |
| Secondary | 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 | 5 years | |
| Secondary | 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) | 3 months |