Nasopharyngeal CarcinomaNCT03398980
Late Sequelae of Childhood and Adolescent Nasopharyngeal Carcinoma Survivors After Radiotherapy
An observational study of Nasopharyngeal Carcinoma, run by Yuan-hong Gao.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- survivors treated with CRT
- Type of treatment
- Surgery or procedure
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- 2 Sep 2016to 10 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All NPC patients younger than 18 years old treated at SYSUCC from February 1991 to October 2010.
Who may be able to join
- Clinical diagnosis of nasopharyngeal carcinoma.
- Nasopharyngeal carcinoma patients younger than 18 years old.
- Nasopharyngeal carcinoma patients who have survived.
Who cannot join
- Patients have other diseases.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- survivors treated with CRT
- Keywords
- Childhood and Adolescent, Survivors, Radiotherapy, Late Sequelae
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
survivors treated with CRTRadiation
Also called survivors treated with IMRT
Radiotherapy technology included conventional radiotherapy (CRT) and intensity-modulated radiotherapy (IMRT).
| Study group | Role | What they receive |
|---|---|---|
| survivors treated with CRT | Childhood and Adolescent Nasopharyngeal Carcinoma survivors who were treated with convention radiotherapy (CRT). Receives: Radiation: survivors treated with CRT | |
| survivors treated with IMRT | Childhood and Adolescent Nasopharyngeal Carcinoma survivors who were treated with intensity-modulated radiotherapy (IMRT). Receives: Radiation: survivors treated with CRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to almost 27 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start2 Sep 2016
- Primary completion10 Jan 2017
- Study completion10 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuan-hong Gao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuan-hong Gao, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398980
- Sponsor's protocol ID
- NPC-C-2017
- Status last verified
- Jan 2018
- First submitted
- 29 Dec 2017
- Last updated
- 16 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late Sequelae of Childhood and Adolescent Nasopharyngeal Carcinoma Survivors After Radiotherapy
- ClinicalTrials.gov ID
- NCT03398980
- Acronym / sponsor ID
- NPC-C-2017
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Childhood and Adolescent, Survivors, Radiotherapy, Late Sequelae
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Yuan-hong GaoUniversity, hospital or other
- Study start
- 2 Sep 2016 (actual)
- Primary completion
- 10 Jan 2017 (actual)
- Study completion
- 10 Jan 2017 (actual)
- First posted
- 16 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| survivors treated with CRT | – | Radiation: survivors treated with CRTChildhood and Adolescent Nasopharyngeal Carcinoma survivors who were treated with convention radiotherapy (CRT). |
| survivors treated with IMRT | – | Radiation: survivors treated with CRTChildhood and Adolescent Nasopharyngeal Carcinoma survivors who were treated with intensity-modulated radiotherapy (IMRT). |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All NPC patients younger than 18 years old treated at SYSUCC from February 1991 to October 2010.
Key inclusion criteria (3 listed)
- Clinical diagnosis of nasopharyngeal carcinoma.
- Nasopharyngeal carcinoma patients younger than 18 years old.
- Nasopharyngeal carcinoma patients who have survived.
Key exclusion criteria (1 listed)
- Patients have other diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| survivors treated with CRTAlso: survivors treated with IMRTRadiotherapy technology included conventional radiotherapy (CRT) and intensity-modulated radiotherapy (IMRT). | Radiation | survivors treated with CRT, survivors treated with IMRT |
Primary outcome
The frequency of some sequelae between survivors treated with CRT and IMRT
Time frame: up to almost 27 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Carcinoma, run by Yuan-hong Gao.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of some sequelae between survivors treated with CRT and IMRT (time frame: up to almost 27 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2018.