Nasopharyngeal CarcinomaPhase 2NCT05020067
Impact on Xerostomia for Nasopharyngeal Carcinoma Patients Treated With or Without Superficial Parotid Lobe-sparing Intensity-modulated Radiotherapy
A Phase 2 study testing superficial parotid lobe-sparing intensity-modulated radiotherapy in people with Nasopharyngeal Carcinoma and Radiation-induced Xerostomia, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a prospective phase II clinical randomized controlled study, the purpose of this study is to assess whether superficial parotid lobe-sparing intensity-modulated radiotherapy (SPLS-IMRT) can decrease the incidence of xerostomia versus conventional IMRT (C-IMRT) in NPC patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma, Radiation-induced Xerostomia
- What is being tested?
- superficial parotid lobe-sparing intensity-modulated radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2018to 17 Aug 2021
- Phase
- Phase 2
- 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
Inclusion Criteria:1) newly diagnosed, histologically confirmed World Health Organization (WHO) type II-III NPC; 2) stage I-IVa (T1-4 N0-3M0) according to the staging system of the 8th American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC); 3) no prior antitumor therapy; 4) no tumor involvement in salivary gland; 5) no parotid glands disorder and no history of parotid glands surgery; 6) ages between 18 and 70 years; 7) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and 8) adequate organ function Exclusion Criteria: 1) used salivary stimulating or protecting agent; 2) metachronous or synchronous malignancy; 3) pregnancy or lactation; or 4) severe comorbidities. The pretreatment evaluation included a complete history and physical examination, nasopharyngoscopy, chest X-ray, complete blood count, liver and renal biochemistry, and magnetic resonance imaging (MRI) of the head and neck.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact on Xerostomia for Nasopharyngeal Carcinoma Patients Treated With or Without Superficial Parotid Lobe-sparing Intensity-modulated Radiotherapy: a Prospective Phase II Clinical Randomized Controlled Study
This is a prospective phase II clinical randomized controlled study, the purpose of this study is to assess whether superficial parotid lobe-sparing intensity-modulated radiotherapy (SPLS-IMRT) can decrease the incidence of xerostomia versus conventional IMRT (C-IMRT) in NPC patients.
- Being tested
- superficial parotid lobe-sparing 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.
superficial parotid lobe-sparing intensity-modulated radiotherapyRadiation
The superficial parotid lobe was contoured as an OAR, and V26 (the percentage volume receiving 26 Gy or more) in the superficial parotid lobe was constrained to be less than 30%.
| Study group | Role | What they receive |
|---|---|---|
| SPLS-IMRT | Experimental | The superficial parotid lobe was contoured as an OAR, and V26 (the percentage volume receiving 26 Gy or more) in the superficial parotid lobe was constrained to be less than 30% Receives: Radiation: superficial parotid lobe-sparing intensity-modulated radiotherapy |
| C-IMRT | No intervention | The entire parotid gland was delineated as an OAR, and V36 (the percentage volume receiving 36 Gy or more) in the entire parotid gland was constrained to be less than 40% |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of xerostomia
the incidence of xerostomia at 12m post-RT based on Radiation Therapy Oncology Group (RTOG) criteria
Measured: 12 months
Secondary outcomes (5)
xerostomia questionnaire score
The XQ consisted of 8 specific questions which were listed as follows: difficulty in talking; difficulty in chewing; difficulty in swallowing solid food; frequency of sleeping problems; mouth and throat dryness when eating food; mouth and throat dryness while not eating; frequency of sipping liquids to aid swallowing food; frequency of sipping liquids for oral comfort when not eating.
Measured: 12 months
Salivary flow rate
unstimulated salivary flow rateand stimulated salivary flow rate
Measured: 12 months
locoregional relapse-free survival
Measured: 36 months
distant metastasis-free survival
Measured: 36 months
overall survival
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start12 Jan 2018
- Primary completion6 Nov 2019
- Study completion17 Aug 2021
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 Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Chong, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020067
- Sponsor's protocol ID
- SPLS-IMRT NPC
- Status last verified
- Aug 2021
- First submitted
- 20 Aug 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huang H, Miao J, Xiao X, Hu J, Zhang G, Peng Y, Lu S, Liang Y, Huang S, Han F, Deng X, Zhao C, Wang L. Impact on xerostomia for nasopharyngeal carcinoma patients treated with superficial parotid lobe-sparing intensity-modulated radiation therapy (SPLS-IMRT): A prospective phase II randomized controlled study. Radiother Oncol. 2022 Oct;175:1-9. doi: 10.1016/j.radonc.2022.07.006. Epub 2022 Jul 8.
PubMed 35817320
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Xerostomia for Nasopharyngeal Carcinoma Patients Treated With or Without Superficial Parotid Lobe-sparing Intensity-modulated Radiotherapy: a Prospective Phase II Clinical Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05020067
- Acronym / sponsor ID
- SPLS-IMRT NPC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 6 Nov 2019 (actual)
- Study completion
- 17 Aug 2021 (actual)
- First posted
- 25 Aug 2021 (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 phase II clinical randomized controlled study, the purpose of this study is to assess whether superficial parotid lobe-sparing intensity-modulated radiotherapy (SPLS-IMRT) can decrease the incidence of xerostomia versus conventional IMRT (C-IMRT) in NPC patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPLS-IMRT | Experimental | Radiation: superficial parotid lobe-sparing intensity-modulated radiotherapyThe superficial parotid lobe was contoured as an OAR, and V26 (the percentage volume receiving 26 Gy or more) in the superficial parotid lobe was constrained to be less than 30% |
| C-IMRT | No intervention | –The entire parotid gland was delineated as an OAR, and V36 (the percentage volume receiving 36 Gy or more) in the entire parotid gland was constrained to be less than 40% |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| superficial parotid lobe-sparing intensity-modulated radiotherapyThe superficial parotid lobe was contoured as an OAR, and V26 (the percentage volume receiving 26 Gy or more) in the superficial parotid lobe was constrained to be less than 30%. | Radiation | SPLS-IMRT |
Primary outcome
the incidence of xerostomia
Time frame: 12 months
the incidence of xerostomia at 12m post-RT based on Radiation Therapy Oncology Group (RTOG) criteria
5 secondary outcomes
xerostomia questionnaire score
Time frame: 12 months
Salivary flow rate
Time frame: 12 months
locoregional relapse-free survival
Time frame: 36 months
distant metastasis-free survival
Time frame: 36 months
overall survival
Time frame: 36 months
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 25 Aug 2021.
- Derived from this study: PubMed 35817320Huang H, Miao J, Xiao X, Hu J, Zhang G, Peng Y, Lu S, Liang Y, Huang S, Han F, Deng X, Zhao C, Wang L. Impact on xerostomia for nasopharyngeal carcinoma patients treated with superficial parotid lobe-sparing intensity-modulated radiation therapy (SPLS-IMRT): A prospective phase II randomized controlled study. Radiother Oncol. 2022 Oct;175:1-9. doi: 10.1016/j.radonc.2022.07.006. Epub 2022 Jul 8.
- Home Page of Cancer Center, Sun Yat-sen UniversityLink provided by the sponsor.
Related trials for Nasopharyngeal Carcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
Not yet recruitingObservational study
Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
Nasopharyngeal Carcinoma (NPC)
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing superficial parotid lobe-sparing intensity-modulated radiotherapy in people with Nasopharyngeal Carcinoma and Radiation-induced Xerostomia, run by Sun Yat-sen University 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?
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 25 Aug 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 incidence of xerostomia (time frame: 12 months). 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 NCT05020067, 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 25 Aug 2021.