Nasopharyngeal CarcinomaNCT03411954
Hippocampus Avoidance During Intensity Modulated Radiotherapy for T4 Nasopharyngeal Carcinoma Patients
An observational study of Nasopharyngeal Carcinoma, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
This is a prospective, non-randomized phase III study observing the cognitive function changes with conformal hippocampus avoidance during intensity modulated radiotherapy for T4 nasopharyngeal carcinoma patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to Mar 2022
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100
Who may be able to join
- Histologically or cytologic confirmed nasopharyngeal carcinoma
- ECOG performance scale 0-2
- Tumor stage is T4N0-3M0-1 according to 8th American Joint Commission on Cancer edition
- Adequate hepatic, renal and hematologic functions (hemoglobin ≥ 90g/L, platelets ≥ 100×10^9/L, neutrophils ≥ 1.5×10^9/L, serum transaminase < 2.5×the upper limit of normal(ULN), (If liver metastases, serum transaminase< 5×the ULN), creatinine clearance rate > 60ml/min.
- Informed consent signed.
Who cannot join
- History of malignant tumors.
- Any severe complications contraindicated chemotherapy or radiotherapy.
- Medical history of central nervous system, cognitive or psychological diseases;
- Pregnant or nursing women.
- Patients with mental disease cannot complete the questionaire.
- MRI contraindication -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
yuanyuan chen, Professor, +86 13738103808, chenyy@zjcc.org.cn
About this study
Official title: Hippocampus Avoidance During Intensity Modulated Radiotherapy for T4 Nasopharyngeal Carcinoma Patients:an Open, Prospective,Non-randomized Phase III Clinical Trial
This is a prospective, non-randomized phase III study observing the cognitive function changes with conformal hippocampus avoidance during intensity modulated radiotherapy for T4 nasopharyngeal carcinoma patients.
Read the detailed description
All patients received intensity modulated radiotherapy or Tomotherapy with or without chemotherapy. Before radiotherapy, the patients will receive brain MRI scanning and the brain MRI images will be fused with the head and neck CT scan images. The investigators develop the treatment plan with hippocampus avoidance. Cognitive function are evaluated before,during and after radiotherapy. Dose-volume Histograms are got to analyze the associated factors.
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- hippocampus avoidance, cognitive changes, intensity modulated radiotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HP-RT | Hippocampus avoidance: decrease the dose to hippocampus as low as possible without affecting the target volumes and other normal tissues |
What is being measured
The primary outcome is the main question the study is designed to answer.
the dose-volume relationship between hippocampus and cognitive function
To explore the relationship between cognitive impairment and exposure dose of hippocampus in patients with nasopharyngeal carcinoma.
Measured: 1 year
Secondary outcomes (3)
cognitive function changes
response to the Montreal Cognitive Assessment
Measured: 1 year
memory function changes
response to the Hopkins Verbal Learning Test
Measured: 1 year
quality of life
response to the QLQ-C30
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start1 Jan 2018
- Primary completionFeb 2021 (estimated)
- Study completionMar 2022 (estimated)
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.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yuanyaun chen, professor, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411954
- Sponsor's protocol ID
- NPC-2017-209
- Status last verified
- Jan 2018
- First submitted
- 13 Jan 2018
- Last updated
- 26 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hippocampus Avoidance During Intensity Modulated Radiotherapy for T4 Nasopharyngeal Carcinoma Patients:an Open, Prospective,Non-randomized Phase III Clinical Trial
- ClinicalTrials.gov ID
- NCT03411954
- Acronym / sponsor ID
- NPC-2017-209
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- hippocampus avoidance, cognitive changes, intensity modulated radiotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 26 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.
This is a prospective, non-randomized phase III study observing the cognitive function changes with conformal hippocampus avoidance during intensity modulated radiotherapy for T4 nasopharyngeal carcinoma patients.
Detailed description
All patients received intensity modulated radiotherapy or Tomotherapy with or without chemotherapy. Before radiotherapy, the patients will receive brain MRI scanning and the brain MRI images will be fused with the head and neck CT scan images. The investigators develop the treatment plan with hippocampus avoidance. Cognitive function are evaluated before,during and after radiotherapy. Dose-volume Histograms are got to analyze the associated factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HP-RT | – | –Hippocampus avoidance: decrease the dose to hippocampus as low as possible without affecting the target volumes and other normal tissues |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100
Key inclusion criteria (5 listed)
- Histologically or cytologic confirmed nasopharyngeal carcinoma
- ECOG performance scale 0-2
- Tumor stage is T4N0-3M0-1 according to 8th American Joint Commission on Cancer edition
- Adequate hepatic, renal and hematologic functions (hemoglobin ≥ 90g/L, platelets ≥ 100×10^9/L, neutrophils ≥ 1.5×10^9/L, serum transaminase < 2.5×the upper limit of normal(ULN), (If liver metastases, serum transaminase< 5×the ULN), creatinine clearance rate > 60ml/min.
- Informed consent signed.
Key exclusion criteria (6 listed)
- History of malignant tumors.
- Any severe complications contraindicated chemotherapy or radiotherapy.
- Medical history of central nervous system, cognitive or psychological diseases;
- Pregnant or nursing women.
- Patients with mental disease cannot complete the questionaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the dose-volume relationship between hippocampus and cognitive function
Time frame: 1 year
To explore the relationship between cognitive impairment and exposure dose of hippocampus in patients with nasopharyngeal carcinoma.
3 secondary outcomes
cognitive function changes
Time frame: 1 year
memory function changes
Time frame: 1 year
quality of life
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Individual participant dataSharing planned: No
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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.
yuanyaun chen, professor principal investigator
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Carcinoma, run by Zhejiang Cancer Hospital at 1 site in China.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yuanyuan chen, professor (+86 13738103808, chenyy@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the dose-volume relationship between hippocampus and cognitive function (time frame: 1 year). 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 26 Jan 2018.