Injury; Temporal RegionNCT03539250
Dose Constraints for the Temporal Lobes of Intensity-modulated Radiotherapy Treatment Plans for Nasopharyngeal Carcinoma
A study testing IMRT in people with Injury; Temporal Region, run by Jiangxi Provincial Cancer Hospital.
Trial summary
Radiation-induced temporal lobe injury (TLI) is usually devastating to patients; however, there is a poor understanding of TLI in nasopharyngeal carcinoma (NPC) patients treated with IMRT. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Injury; Temporal Region
- What is being tested?
- IMRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2018to 31 May 2025
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly-diagnosed and confirmed histopathologic diagnosis of nasopharyngeal squamous cell carcinoma, types WHO II-III, Stage I-IVA (AJCC staging, 2017, 8th edition), treated with intensity-modulated radiotherapy.
- No head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies.
- Age between 18 years and 70 years.
- Karnofsky score ≥80
- WBC≥ 4,000/ul, platelets≥ 100,000/ul; serum creatinine≤ 1.6 mg/dl or 24hr. calculated creatinine clearance ≥ 60ml/min.
- Must undergo pre-treatment evaluation of tumor extent and tumor measurement. Tumor may be measurable or evaluable.
- Signed study-specific consent form prior to study entry.
Who cannot join
- Stage IVB
- Evidence of distant metastases
- Previous irradiation for head and neck tumor ≤ 6 months prior to study entry
- Previous chemotherapy ≤ 6 months prior to study entry
- Patient is on other experimental therapeutic cancer treatment
- Other malignancy except non-melanoma skin cancer or a carcinoma not of head and neck origin and controlled at least 5 years
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- Active untreated infection
- Major medical or psychiatric illness, which in the investigator's opinions, would interfere with either the completion of therapy and follow-up or with full and complete understanding of the risks and potential complications of the therapy
- Pregnant women
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Dose Constraints for the Temporal Lobes During the Optimization of Intensity-modulated Radiotherapy Treatment Plans for Nasopharyngeal Carcinoma
Radiation-induced temporal lobe injury (TLI) is usually devastating to patients; however, there is a poor understanding of TLI in nasopharyngeal carcinoma (NPC) patients treated with IMRT. Knowledge of the dose tolerance of the TL is essential, in order to predict the safety of intensity-modulated radiotherapy (IMRT) treatment plans. In our previous studies, D1cc (the dose to 1ml of the TL volume) and Dmax (the maximum point dose) were the significant predictors of TLI development. The purpose of this study is to evaluate the feasibility of dose constraints based on D1cc and Dmax for the temporal lobes following IMRT for NPC.
Read the detailed description
The prescribe dose was 66-70Gy to the PTV of the GTVnx, 60Gy to the PTV of CTV1(i.e., high-risk regions),54-56Gy to the PTV of CTV2(i.e., low-risk regions),and 64-66Gy to the PTV of the GTVnd for the metastatic cervical lymph nodes in 30-33 fractions. For the GTV and CTV, the target volumes that received more than 95% of the prescribed dose was used to reflect the target coverage. Subdivision of the PTVnx into regions with different prescribed absorbed doses (PTVsv1,PTVsv2, PTVsv2 is the overlaps between PTVnx and temporal lobe) can be used in cases for which the PTVnx overlaps temporal lobe. When the volume of PTVsv2 is less than 0.2 cubic centimeter (cc), the prescribe dose for PTVsv2 is as the same as that of the PTVsv1, D1cc 63.1Gy, Dmax 72.9Gy for TL (32 fractions). When the volume of PTVsv2 is between 0.2 cc and 0.5cc, the prescribe dose for PTVsv2 is 66Gy, D1cc 63.1Gy, Dmax 72.9Gy for TL (32 fractions). When the volume of PTVsv2 is between 0.5 cc and 1cc, the prescribe dose for PTVsv2 is 66Gy, D1cc 65.8Gy, Dmax 75.2Gy for TL (32 fractions).
- Conditions
- Injury; Temporal Region
- Being tested
- IMRT
- Keywords
- Radiation-induced temporal lobe injury;NPC, Nasopharyngeal carcinoma, Intensity-modulated radiotherapy
- Medical subject headings
- Wounds and Injuries, Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMRTRadiation
IMRT with and without chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| IMRT with and without chemotherapy | Experimental | Subdivision of the PTVnx into regions with different prescribed absorbed doses (PTVsv1,PTVsv2, PTVsv2 is the overlaps between PTVnx and temporal lobe) can be used in cases for which the PTVnx overlaps temporal lobe. When the volume of PTVsv2 is less than 0.2 cubic centimeter (cc), the prescribe dose for PTVsv2 is as the same as that of the PTVsv1, D1cc 63.1Gy, Dmax 72.9Gy for TL (32 fractions). When the volume of PTVsv2 is between 0.2 cc and 0.5cc, the prescribe dose for PTVsv2 is 66Gy, D1cc 63.1Gy, Dmax 72.9Gy for TL (32 fractions). When the volume of PTVsv2 is between 0.5 cc and 1cc, the prescribe dose for PTVsv2 is 66Gy, D1cc 65.8Gy, Dmax 75.2Gy for TL (32 fractions). Receives: Radiation: IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of radiation-induced temporal lobe injury at 5 years
The incidence of radiation-induced temporal lobe injury at 5 years will be calculated
Measured: 5 years
Secondary outcomes (1)
Local recurrence-free survival at 5 years
Local recurrence-free survival at 5 years will be calculated
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start10 Jun 2018 (estimated)
- Primary completion31 May 2020 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Injury; Temporal RegionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sixth Affiliated Hospital, Sun Yat-sen University
- Responsible party
- Principal investigator, Qiang Xu, Jiangxi Provincial Cancer Hospital
- Investigators
- Jin-Gao Li, MD, Principal investigator, Jiangxi cancer hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539250
- Sponsor's protocol ID
- zl2017
- Status last verified
- May 2018
- First submitted
- 10 Mar 2018
- Last updated
- 29 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liao H, Wang J, Lai Y, Ding P, Su Y, Dong Q, Hu L, Liu L, Gao X, Xie H, Xiao Y, Zeng L, Lu T, Gong X, Li J. Overlap-Adapted Subvolume Prescription to Reduce Temporal Lobe Injury Risk in T4 Nasopharyngeal Carcinoma: A Prospective Cohort Study With a Contemporaneous Comparator. Pract Radiat Oncol. 2026 Aug 21:S1879-8500(26)00260-2. doi: 10.1016/j.prro.2026.07.007. Online ahead of print.
PubMed 42628876
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Constraints for the Temporal Lobes During the Optimization of Intensity-modulated Radiotherapy Treatment Plans for Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT03539250
- Acronym / sponsor ID
- zl2017
- Conditions
- Injury; Temporal Region
- Keywords
- Radiation-induced temporal lobe injury;NPC, Nasopharyngeal carcinoma, Intensity-modulated radiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Jiangxi Provincial Cancer HospitalUniversity, hospital or other
- Collaborators
- Sixth Affiliated Hospital, Sun Yat-sen University
- Study start
- 10 Jun 2018 (estimated)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 29 May 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.
Radiation-induced temporal lobe injury (TLI) is usually devastating to patients; however, there is a poor understanding of TLI in nasopharyngeal carcinoma (NPC) patients treated with IMRT. Knowledge of the dose tolerance of the TL is essential, in order to predict the safety of intensity-modulated radiotherapy (IMRT) treatment plans. In our previous studies, D1cc (the dose to 1ml of the TL volume) and Dmax (the maximum point dose) were the significant predictors of TLI development. The purpose of this study is to evaluate the feasibility of dose constraints based on D1cc and Dmax for the temporal lobes following IMRT for NPC.
Detailed description
The prescribe dose was 66-70Gy to the PTV of the GTVnx, 60Gy to the PTV of CTV1(i.e., high-risk regions),54-56Gy to the PTV of CTV2(i.e., low-risk regions),and 64-66Gy to the PTV of the GTVnd for the metastatic cervical lymph nodes in 30-33 fractions. For the GTV and CTV, the target volumes that received more than 95% of the prescribed dose was used to reflect the target coverage. Subdivision of the PTVnx into regions with different prescribed absorbed doses (PTVsv1,PTVsv2, PTVsv2 is the overlaps between PTVnx and temporal lobe) can be used in cases for which the PTVnx overlaps temporal lobe. When the volume of PTVsv2 is less than 0.2 cubic centimeter (cc), the prescribe dose for PTVsv2 is as the same as that of the PTVsv1, D1cc 63.1Gy, Dmax 72.9Gy for TL (32 fractions). When the volume of PTVsv2 is between 0.2 cc and 0.5cc, the prescribe dose for PTVsv2 is 66Gy, D1cc 63.1Gy, Dmax 72.9Gy for TL (32 fractions). When the volume of PTVsv2 is between 0.5 cc and 1cc, the prescribe dose for PTVsv2 is 66Gy, D1cc 65.8Gy, Dmax 75.2Gy for TL (32 fractions).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMRT with and without chemotherapy | Experimental | Radiation: IMRTSubdivision of the PTVnx into regions with different prescribed absorbed doses (PTVsv1,PTVsv2, PTVsv2 is the overlaps between PTVnx and temporal lobe) can be used in cases for which the PTVnx overlaps temporal lobe. When the volume of PTVsv2 is less than 0.2 cubic centimeter (cc), the prescribe dose for PTVsv2 is as the same as that of the PTVsv1, D1cc 63.1Gy, Dmax 72.9Gy for TL (32 fractions). When the volume of PTVsv2 is between 0.2 cc and 0.5cc, the prescribe dose for PTVsv2 is 66Gy, D1cc 63.1Gy, Dmax 72.9Gy for TL (32 fractions). When the volume of PTVsv2 is between 0.5 cc and 1cc, the prescribe dose for PTVsv2 is 66Gy, D1cc 65.8Gy, Dmax 75.2Gy for TL (32 fractions). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Newly-diagnosed and confirmed histopathologic diagnosis of nasopharyngeal squamous cell carcinoma, types WHO II-III, Stage I-IVA (AJCC staging, 2017, 8th edition), treated with intensity-modulated radiotherapy.
- No head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies.
- Age between 18 years and 70 years.
- Karnofsky score ≥80
- WBC≥ 4,000/ul, platelets≥ 100,000/ul; serum creatinine≤ 1.6 mg/dl or 24hr. calculated creatinine clearance ≥ 60ml/min.
Key exclusion criteria (9 listed)
- Stage IVB
- Evidence of distant metastases
- Previous irradiation for head and neck tumor ≤ 6 months prior to study entry
- Previous chemotherapy ≤ 6 months prior to study entry
- Patient is on other experimental therapeutic cancer treatment
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 |
|---|---|---|
| IMRTIMRT with and without chemotherapy | Radiation | IMRT with and without chemotherapy |
Primary outcome
The incidence of radiation-induced temporal lobe injury at 5 years
Time frame: 5 years
The incidence of radiation-induced temporal lobe injury at 5 years will be calculated
1 secondary outcome
Local recurrence-free survival at 5 years
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2018.
- Derived from this study: PubMed 42628876Liao H, Wang J, Lai Y, Ding P, Su Y, Dong Q, Hu L, Liu L, Gao X, Xie H, Xiao Y, Zeng L, Lu T, Gong X, Li J. Overlap-Adapted Subvolume Prescription to Reduce Temporal Lobe Injury Risk in T4 Nasopharyngeal Carcinoma: A Prospective Cohort Study With a Contemporaneous Comparator. Pract Radiat Oncol. 2026 Aug 21:S1879-8500(26)00260-2. doi: 10.1016/j.prro.2026.07.007. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
Jin-Gao Li, MD principal investigator
Jiangxi cancer hospital, China
Questions about this trial
What is this clinical trial studying?
A study testing IMRT in people with Injury; Temporal Region, run by Jiangxi Provincial Cancer Hospital.
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 7 inclusion and 9 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 29 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Zeng, MD ((86)0791-88314495, zlsports100@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of radiation-induced temporal lobe injury at 5 years (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03539250, which also lists 1 linked publication.
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 29 May 2018.