Brief Title
Late Sequelae of Childhood and Adolescent Nasopharyngeal Carcinoma Survivors After Radiotherapy
Official Title
Late Sequelae of Childhood and Adolescent Nasopharyngeal Carcinoma Survivors After Radiotherapy
Brief Summary
Although children and adolescents are more likely to have advanced disease at onset, they
generally have a significantly better chance of survival. With combined chemotherapy and
radiotherapy, overall survival has been reported more than 75% in most pediatric studies.
However, little research focuses on long-term morbidities of children and adolescent
nasopharyngeal carcinoma (NPC) survivors, and most studies are small scale and have short
follow-up time. Therefore, this study analyzed the long-term morbidities of children and
adolescent NPC survivors after radiotherapy. Factors associated with those morbidities were
also analyzed.
We reviewed the medical records of all NPC patients younger than 18 years old treated at Sun
Yat-sen University Cancer Center (SYSUCC) from February 1991 to October 2010. Detailed
medical records were taken from our institutional database. Patients were also followed using
comprehensive questionnaires and phone calls. We extracted data on clinical characteristics,
histopathology, imaging findings, treatment, outcomes, and late morbidities.
Patients with early-stage (stage I and II) disease were treated with radiotherapy alone, and
patients with advanced-stage disease (stage III and IV) were treated with a combination of
radiotherapy and chemotherapy. Radiotherapy technology included conventional radiotherapy
(CRT) and intensity-modulated radiotherapy (IMRT).
We retrospectively reviewed these medical records to collect the required data. All survivors
returned to the hospital for follow-up examinations at least every 3 months for the first
year, at least every 6 months in the 2nd year, and at least every one year thereafter until
the latest follow-up. As part of our routine clinical practice, all patients underwent
follow-up MRI examinations of the nasopharynx and neck at least every 6 to 12 months.
Radioactive toxicity on organs was evaluated based on National Cancer Institute Common
Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0.
Analyses were performed using SPSS software, version 16.0 (SPSS, Chicago, IL). Chi-squared
tests and binary regression analysis were used to compare the CI of treatment comorbidities
between different groups of survivors. A P value of 0.05 was chosen as the criteria for
statistical significance.
Detailed Description
Introduction Nasopharyngeal carcinoma (NPC) is an uncommon childhood malignancy. As the high
incidence of local-regional advanced disease, its undifferentiated histology and its close
association with Epstein-Barr virus (EBV) , it is distinguishable from the adult form of the
disease. Treatment strategies for childhood NPC follow guidelines established for adults.
Although children and adolescents are more likely to have advanced disease at onset, they
generally have a significantly better chance of survival. With combined chemotherapy and
radiotherapy, overall survival has been reported more than 75% in most pediatric studies.
However, late sequelae such as endocrinopathies, hearing disorder, dental problems, life-long
dry mouth, and secondary neoplasms have been reported. Little research focuses on long-term
morbidities of children and adolescent NPC survivors, and most studies are small scale and
have short follow-up time. Therefore, this study analyzed the long-term morbidities of
children and adolescent NPC survivors after radiotherapy. Factors associated with those
morbidities were also analyzed.
Methods and Materials Patients We reviewed the medical records of all NPC patients younger
than 18 years old treated at Sun Yat-sen University Cancer Center (SYSUCC) from February 1991
to October 2010. Detailed medical records were taken from our institutional database.
Patients were also followed using comprehensive questionnaires and phone calls. All patients
were restaged according to the Union for International Cancer Control (UICC) TNM
classification version 2009 of NPC. We extracted data on clinical characteristics,
histopathology, imaging findings, treatment, outcomes, and late morbidities. Informed consent
was obtained from all patients.
Treatment protocols The main treatment strategy for patients was based on the National
Comprehensive Cancer Network Guidelines. Patients with early-stage (stage I and II) disease
were treated with radiotherapy alone, and patients with advanced-stage disease (stage III and
IV) were treated with a combination of radiotherapy and chemotherapy. NPC patients were
treated with a high-dose of radiotherapy to the nasopharynx and the involved lymph nodes of
the neck, and a moderate dose of radiation to uninvolved nodes and surrounding tissues.
Radiotherapy technology included conventional radiotherapy (CRT) and intensity-modulated
radiotherapy (IMRT). Patients between 1991 and 2004 received CRT. Post 2004, IMRT became the
standard strategy treatment. During the study period, chemotherapy guidelines for NPC were
implemented as follows: no chemotherapy for patients with stage I to II disease, and
concurrent chemoradiotherapy + neoadjuvant chemotherapy for stage III to IVa-c.
Follow up We retrospectively reviewed these medical records to collect the required data. All
survivors returned to the hospital for follow-up examinations at least every 3 months for the
first year, at least every 6 months in the 2nd year, and at least every one year thereafter
until the latest follow-up. As part of our routine clinical practice, all patients underwent
follow-up MRI examinations of the nasopharynx and neck at least every 6 to 12 months.
Evaluation Criterion Radioactive toxicity on organs was evaluated based on National Cancer
Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0.
Statistical analysis Analyses were performed using SPSS software, version 16.0 (SPSS,
Chicago, IL). Chi-squared tests and binary regression analysis were used to compare the CI of
treatment comorbidities between different groups of survivors. A P value of 0.05 was chosen
as the criteria for statistical significance.
Study Type
Observational
Primary Outcome
The frequency of some sequelae between survivors treated with CRT and IMRT
Condition
Nasopharyngeal Carcinoma
Intervention
survivors treated with CRT
Study Arms / Comparison Groups
survivors treated with CRT
Description: Childhood and Adolescent Nasopharyngeal Carcinoma survivors who were treated with convention radiotherapy (CRT).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Radiation
Estimated Enrollment
94
Start Date
September 2, 2016
Completion Date
January 10, 2017
Primary Completion Date
January 10, 2017
Eligibility Criteria
Inclusion Criteria:
1. Clinical diagnosis of nasopharyngeal carcinoma.
2. Nasopharyngeal carcinoma patients younger than 18 years old.
3. Nasopharyngeal carcinoma patients who have survived.
Exclusion Criteria:
1. Patients have other diseases.
Gender
All
Ages
7 Years - 18 Years
Accepts Healthy Volunteers
No
Contacts
, ,
Administrative Informations
NCT ID
NCT03398980
Organization ID
NPC-C-2017
Responsible Party
Sponsor-Investigator
Study Sponsor
Yuan-hong Gao
Study Sponsor
, ,
Verification Date
January 2018