Nasopharyngeal Carcinoma ,Xerostomia,RadiotherapyNCT06282497
Xerostomia-optimised IMRT Versus Standard IMRT in NPC
A study testing Optimised neck CTV and standard neck CTV in people with Nasopharyngeal Carcinoma ,Xerostomia,Radiotherapy, run by Zhongshan People's Hospital, Guangdong, China at 1 site in China.
Trial summary
This is a multi-center, non-inferiority, open-label, randomized controlled phase III clinical trial in primary diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma ,Xerostomia,Radiotherapy
- What is being tested?
- Optimised neck CTV and standard neck CTV
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 524 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2023to 23 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 histologic diagnosis of nasopharyngeal non-keratinizing carcinoma (WHO II/III);
- All genders, range from 18-70 years old;
- ECOG score 0-1;
- Clinical stage I-IVa (AJCC/UICC 8th);
- Not received radiotherapy, chemotherapy and other anti-tumor treatment (including immunotherapy);
- No contraindications to chemotherapy or radiotherapy;
- Adequate organ function: white blood cell count ≥ 4×109/L, neutrophile granulocyte count ≥ 1.5×109/L, hemoglobin ≥ 90g/L, platelet count ≥ 100×109/L; alanine aminotransferase or aspartate aminotransferase < 2.5×upper limit of normal; blood urea nitrogen or creatinine ≤ 1.5×upper limit of normal or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
- Sign the consent form.
Who cannot join
- Level II involvement with extracapsular extension (ECE), and/or had a maximum nodal axial diameter (MAD) of greater than 3cm in level II ;
- -≥4 nodal regions of ipsilateral neck involvement;
- Radiologically suspicious or confirmed involvement in level II area between skull base and the lateral process of C1;
- Parotid lymph node and/or parotid gland involvement;
- History of parotid disease or surgery;
- Previous malignancy or other concomitant malignant disease;
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan City People's Hospital
Zhongshan, Guangdong, 528403
Gui-qiong Xu, MD, +8613528109888, donna_shee@163.com
About this study
Official title: Xerostomia-optimised Intensity-modulated Radiotherapy Versus Standard Intensity-modulated Radiotherapy in Nasopharyngeal Carcinoma Patients:a Multicenter Non-inferior Randomized Controlled Phase III Clinical Trial
This is a multi-center, non-inferiority, open-label, randomized controlled phase III clinical trial in primary diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. This study aims to compare the regional control, survival outcomes, radiation-related toxicities, and quality of life (QoL) of xerostomia-optimized intensity-modulated radiotherapy versus standard intensity-modulated radiotherapy in NPC patients
Read the detailed description
Xerostomia remains one of the most common radiation-induced toxicities, and approximately 80% to 90% of NPC patients still experience varying degrees of xerostomia post-IMRT. Among the major salivary glands, the parotid gland is the largest and produces 60% to 65% of the oral saliva output. Studies have revealed that xerostomia post-IMRT is mainly dependent on the irradiation dose of the parotid glands. Clinical target volumes (CTV) for the cervical nodal region starting from skull base have been the standard in nasopharyngeal carcinoma for several decades. Consequently, the parotid glands overlap with the target volumes and irradiation dose reaches 31.7 Gy to 43.9 Gy in most reports. Retrospective studies reveal that the lateral process of C1 is a suitable cranial edge for neck CTV delineation; therefore, the volume of the parotid glands exposed to high radiation doses can be greatly reduced. we conducted this trial comparing outcomes ,toxicities and QoL of xerostomia-optimized intensity-modulated radiotherapy versus standard intensity-modulated radiotherapy in nasopharyngeal carcinoma.
- Being tested
- Optimised neck CTV, standard neck CTV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimised neck CTVRadiation
neck CTV delineation extends from the lateral process of C1
standard neck CTVRadiation
neck CTV delineation extends from skull base
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | optimised neck CTV delineation Receives: Radiation: Optimised neck CTV |
| Control Group | Active comparator | standard neck CTV delineation Receives: Radiation: standard neck CTV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional recurrence free survival
From the date of randomization to regional recurrence or any death
Measured: 3 years
Secondary outcomes (6)
Overall survival
From the date of randomization to any death, with patients unavailable for follow-up censored at the date of last follow-up
Measured: 3 years
Local recurrence free survival
From the date of randomization to local recurrence or any death
Measured: 3 years
Distant metastasis-free survival
From the date of randomization to distant metastasis or any death
Measured: 3 years
Progression free survival
From the date of randomization to local or regional recurrence, distant metastasis or any death
Measured: 3 years
Acute toxicities
Assessed with CTCAE v5.0
Measured: From the start of treatment until 3 months post treatment
Late toxicities
Assessed with Radiation Therapy Oncology Group criteria and the CTCAE v5.0
Measured: 3 years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start23 Oct 2023
- Primary completion23 Oct 2026 (estimated)
- Study completion23 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Carcinoma ,Xerostomia,RadiotherapyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 524 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan People's Hospital, Guangdong, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gui-Qiong Xu, Zhongshan People's Hospital, Guangdong, China
- Investigators
- Gui-qiong Xu, MD, Principal investigator, Zhongshan People's Hospital, Guangdong, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282497
- Sponsor's protocol ID
- ZSCPH-003
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2024
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xerostomia-optimised Intensity-modulated Radiotherapy Versus Standard Intensity-modulated Radiotherapy in Nasopharyngeal Carcinoma Patients:a Multicenter Non-inferior Randomized Controlled Phase III Clinical Trial
- ClinicalTrials.gov ID
- NCT06282497
- Acronym / sponsor ID
- ZSCPH-003
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 524 participants (estimated)
- Lead sponsor
- Zhongshan People's Hospital, Guangdong, ChinaUniversity, hospital or other
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 23 Oct 2026 (estimated)
- Study completion
- 23 Oct 2029 (estimated)
- First posted
- 28 Feb 2024 (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 multi-center, non-inferiority, open-label, randomized controlled phase III clinical trial in primary diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. This study aims to compare the regional control, survival outcomes, radiation-related toxicities, and quality of life (QoL) of xerostomia-optimized intensity-modulated radiotherapy versus standard intensity-modulated radiotherapy in NPC patients
Detailed description
Xerostomia remains one of the most common radiation-induced toxicities, and approximately 80% to 90% of NPC patients still experience varying degrees of xerostomia post-IMRT. Among the major salivary glands, the parotid gland is the largest and produces 60% to 65% of the oral saliva output. Studies have revealed that xerostomia post-IMRT is mainly dependent on the irradiation dose of the parotid glands. Clinical target volumes (CTV) for the cervical nodal region starting from skull base have been the standard in nasopharyngeal carcinoma for several decades. Consequently, the parotid glands overlap with the target volumes and irradiation dose reaches 31.7 Gy to 43.9 Gy in most reports. Retrospective studies reveal that the lateral process of C1 is a suitable cranial edge for neck CTV delineation; therefore, the volume of the parotid glands exposed to high radiation doses can be greatly reduced. we conducted this trial comparing outcomes ,toxicities and QoL of xerostomia-optimized intensity-modulated radiotherapy versus standard intensity-modulated radiotherapy in nasopharyngeal carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Radiation: Optimised neck CTVoptimised neck CTV delineation |
| Control Group | Active comparator | Radiation: standard neck CTVstandard neck CTV delineation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Newly histologic diagnosis of nasopharyngeal non-keratinizing carcinoma (WHO II/III);
- All genders, range from 18-70 years old;
- ECOG score 0-1;
- Clinical stage I-IVa (AJCC/UICC 8th);
- Not received radiotherapy, chemotherapy and other anti-tumor treatment (including immunotherapy);
Key exclusion criteria (7 listed)
- Level II involvement with extracapsular extension (ECE), and/or had a maximum nodal axial diameter (MAD) of greater than 3cm in level II ;
- -≥4 nodal regions of ipsilateral neck involvement;
- Radiologically suspicious or confirmed involvement in level II area between skull base and the lateral process of C1;
- Parotid lymph node and/or parotid gland involvement;
- History of parotid disease or surgery;
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 |
|---|---|---|
| Optimised neck CTVneck CTV delineation extends from the lateral process of C1 | Radiation | Study Group |
| standard neck CTVneck CTV delineation extends from skull base | Radiation | Control Group |
Primary outcome
Regional recurrence free survival
Time frame: 3 years
From the date of randomization to regional recurrence or any death
6 secondary outcomes
Overall survival
Time frame: 3 years
Local recurrence free survival
Time frame: 3 years
Distant metastasis-free survival
Time frame: 3 years
Progression free survival
Time frame: 3 years
Acute toxicities
Time frame: From the start of treatment until 3 months post treatment
Late toxicities
Time frame: 3 years post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
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Radiation-induced Xerostomia
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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.
Gui-qiong Xu, MD principal investigator
Zhongshan People's Hospital, Guangdong, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimised neck CTV and standard neck CTV in people with Nasopharyngeal Carcinoma ,Xerostomia,Radiotherapy, run by Zhongshan People's Hospital, Guangdong, China 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 8 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 1 May 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gui-qiong Xu, MD (+8613528109888, donna_shee@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional recurrence free survival (time frame: 3 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 1 May 2024.