Late Sequelae of Childhood and Adolescent Nasopharyngeal Carcinoma Survivors After Radiotherapy

NCT03398980 | Completed

• 1 other identifier: NPC-C-2017
• Study Type: observational
• Target: 94
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nasopharyngeal Carcinoma

Keywords

Childhood and Adolescent; Survivors; Radiotherapy; Late Sequelae

Outcome Measures

Primary Outcomes (1)

• The frequency of some sequelae between survivors treated with CRT and IMRT

  Chi-squared tests and binary regression analysis were used to compare the CI of treatment comorbidities between different groups of survivors. Radioactive toxicity on organs was evaluated based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0.

  up to almost 27 years

Study Arms (2)

survivors treated with CRT

Childhood and Adolescent Nasopharyngeal Carcinoma survivors who were treated with convention radiotherapy (CRT).

Radiation: survivors treated with CRT

survivors treated with IMRT

Childhood and Adolescent Nasopharyngeal Carcinoma survivors who were treated with intensity-modulated radiotherapy (IMRT).

Radiation: survivors treated with CRT

Interventions

survivors treated with CRT RADIATION

Radiotherapy technology included conventional radiotherapy (CRT) and intensity-modulated radiotherapy (IMRT).

Also known as: survivors treated with IMRT

survivors treated with CRT; survivors treated with IMRT

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All NPC patients younger than 18 years old treated at SYSUCC from February 1991 to October 2010.

You may qualify if:

• Clinical diagnosis of nasopharyngeal carcinoma.
• Nasopharyngeal carcinoma patients younger than 18 years old.
• Nasopharyngeal carcinoma patients who have survived.

You may not qualify if:

• Patients have other diseases.

Sponsors & Collaborators

• Yuan-hong Gao: lead

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Director，MD & PhD, Professor，Department of Radiation Oncology

Study Record Dates

• First Submitted: December 29, 2017
• First Posted: January 16, 2018
• Study Start: September 2, 2016
• Primary Completion: January 10, 2017
• Study Completion: January 10, 2017
• Last Updated: January 16, 2018

Record last verified: 2018-01