Nasopharyngeal Carcinoma Clinical Trial
Official title:
Late Sequelae of Childhood and Adolescent Nasopharyngeal Carcinoma Survivors After Radiotherapy
Verified date | January 2018 |
Source | Sun Yat-sen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 94 |
Est. completion date | January 10, 2017 |
Est. primary completion date | January 10, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 18 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Yuan-hong Gao |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05979961 -
Phase III Trial of Concurrent Chemotherapy Alone in Patients With Low-risk Nasopharyngeal Carcinoma
|
Phase 3 | |
Active, not recruiting |
NCT04242199 -
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05415098 -
Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas
|
Phase 1 | |
Recruiting |
NCT06055816 -
Gemcitabine Combined With Endostar and Envafolimab in Elderly Patients With Locally Advanced Nasopharyngeal Carcinoma
|
Phase 2 | |
Recruiting |
NCT05547971 -
Development of Intelligent Model for Radioactive Brain Damage of Nasopharyngeal Carcinoma Based on Radio-metabolomics
|
||
Not yet recruiting |
NCT05020925 -
SHR-1701 in Combination With Famitinib in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT04548271 -
Camrelizumab Combined With Apatinib in Patients With PD-1 Antagonists Resistant Recurrent/Metastatic Nasopharyngeal Carcinoma
|
Phase 2 | |
Not yet recruiting |
NCT04547088 -
Camrelizumab Combined With Apatinib in Patients With First-line Platinum-resistant Recurrent/Metastatic Nasopharyngeal Carcinoma
|
Phase 2 | |
Recruiting |
NCT02795169 -
Trail Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma
|
Phase 1/Phase 2 | |
Terminated |
NCT02569788 -
Trail Evaluating Carbon Ion Radiotherapy for Locally Recurrent Nasopharyngeal Carcinoma
|
Phase 1/Phase 2 | |
Terminated |
NCT02801487 -
Trial Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma
|
Phase 1/Phase 2 | |
Completed |
NCT02237924 -
Endostar Combined With Intensity-modulated Radiotherapy Compare With Chemoradiation for Nasopharyngeal Carcinoma
|
Phase 2 | |
Recruiting |
NCT02044562 -
Dietary Nitrate on Plasma Nitrate Levels for Nasopharyngeal Carcinoma Patients
|
N/A | |
Terminated |
NCT01694576 -
NPC Staged N2-3M0:Adjuvant Chemotherapy or Just Observation After Concurrent Chemoradiation
|
Phase 2 | |
Recruiting |
NCT01462903 -
A Study of Adoptive Immunotherapy With Autologous Tumor Infiltrating Lymphocytes in Solid Tumors
|
Phase 1 | |
Completed |
NCT01271439 -
Study of Chemoradiotherapy Combined With Cetuximab in Nasopharyngeal Carcinoma
|
Phase 2 | |
Completed |
NCT00535795 -
Phase III: Assess Conventional RT w/ Conventional Plus Accelerated Boost RT in the Treatment of Nasopharyngeal CA
|
Phase 3 | |
Completed |
NCT00379262 -
Therapeutic Gain by Induction-concurrent Chemoradiotherapy and/or Accelerated Fractionation for Nasopharyngeal Carcinoma
|
Phase 3 | |
Completed |
NCT01309633 -
Study Evaluating Two Loading Regimens of Sunitinib or Bevacizumab Alternating With Cisplatin and Gemcitabine as Induction Therapy for Locally Advanced Nasopharyngeal Carcinoma (NPC)
|
Phase 2 | |
Not yet recruiting |
NCT05519956 -
Elective Level Ib Irradiation in Nasopharyngeal Carcinoma Patients Based on the International Guidelines
|
Phase 3 |