Nasopharyngeal Carcinoma (NPC)Phase 3NCT07340515
Proton vs Photon IMRT in Locally Advanced Nasopharyngeal Carcinoma: A Phase III Trial
A Phase 3 study testing Intensity-Modulated Proton Therapy (IMPT), Intensity-Modulated Radiation Therapy (IMRT) and Cisplatin in people with Nasopharyngeal Carcinoma (NPC), run by Man Hu at 1 site in China.
Trial summary
This multicenter, open-label, randomized Phase III trial evaluates intensity-modulated proton therapy (IMPT) versus intensity-modulated photon radiotherapy (IMRT) in patients with newly diagnosed, high-risk, locoregionally advanced nasopharyngeal carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC)
- What is being tested?
- Intensity-Modulated Proton Therapy (IMPT), Intensity-Modulated Radiation Therapy (IMRT) and Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2025to 31 Dec 2031
- Phase
- Phase 3
- 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
- Age 18 to 70 years
- Histologically confirmed nasopharyngeal carcinoma (WHO type II or III)
- High-risk locoregionally advanced disease defined as clinical stage T4 or N3, M0, according to the AJCC staging system
- No prior anti-tumor therapy for nasopharyngeal carcinoma, including radiotherapy, chemotherapy, targeted therapy, or immunotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Adequate organ function as defined in the study protocol
- Eligible to receive induction chemotherapy followed by concurrent chemoradiotherapy combined with immunotherapy as specified in the protocol
- Ability to understand and willingness to sign written informed consent
Who cannot join
- Evidence of distant metastasis (M1 disease)
- Prior radiotherapy, chemotherapy, targeted therapy, or immunotherapy for nasopharyngeal carcinoma
- Active autoimmune disease requiring systemic therapy
- Uncontrolled infection or severe comorbidities that may affect treatment tolerance
- Pregnancy or breastfeeding
- Known allergy, hypersensitivity, or contraindication to study medications as defined in the protocol
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation
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
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Jinan, Shandong, 250117
Man Hu, Dr, 86-15806698606, human5770@163.com
About this study
Official title: A Prospective, Randomized, Open-Label, Multicenter Phase III Clinical Study Comparing Intensity-Modulated Proton Therapy and Intensity-Modulated Photon Radiotherapy in Locally Advanced Nasopharyngeal Carcinoma
This multicenter, open-label, randomized Phase III trial evaluates intensity-modulated proton therapy (IMPT) versus intensity-modulated photon radiotherapy (IMRT) in patients with newly diagnosed, high-risk, locoregionally advanced nasopharyngeal carcinoma.
All patients receive induction chemotherapy followed by concurrent chemoradiotherapy combined with immunotherapy and are randomized 1:1 to IMPT or IMRT during the concurrent treatment phase.
The primary endpoints are the incidence of grade ≥3 acute treatment-related toxicities and the 3-year progression-free survival (PFS) rate. Secondary endpoints include overall survival, locoregional relapse-free survival, distant metastasis-free survival, objective response rate, late toxicities, and quality of life.
Read the detailed description
This is a multicenter, open-label, randomized Phase III clinical trial designed to compare the safety and efficacy of intensity-modulated proton therapy (IMPT) versus intensity-modulated photon radiotherapy (IMRT) in patients with newly diagnosed, high-risk, locoregionally advanced nasopharyngeal carcinoma.
Eligible patients are adults aged 18 to 70 years with histologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO type II or III) and clinical stage T4 or N3 disease without distant metastasis (M0), according to the AJCC staging system.
All enrolled patients will receive three cycles of induction chemotherapy consisting of gemcitabine plus cisplatin. This will be followed by concurrent chemoradiotherapy combined with immunotherapy. During the concurrent treatment phase, patients will be randomized in a 1:1 ratio to receive either IMPT or IMRT, delivered according to protocol-defined target delineation, dose prescription, and fractionation schedules.
The first primary endpoint is the incidence of grade ≥3 acute treatment-related toxicities, defined as treatment-related adverse events of grade 3 or higher occurring from the initiation of radiotherapy to 90 days after completion of radiotherapy. Toxicities will be graded according to CTCAE version 5.0 and RTOG criteria. Ototoxicity, including hearing loss or tinnitus, will be further evaluated using the ASHA (1994) significant change criteria for pure-tone audiometry.The second primary endpoint is the 3-year progression-free survival (PFS) rate, defined as the proportion of patients who remain alive without documented disease progression within 3 years after randomization. Disease progression is defined as locoregional recurrence, distant metastasis, or death from any cause, whichever occurs first.
Secondary endpoints include overall survival (OS), defined as the time from randomization to death from any cause; locoregional relapse-free survival (LRRFS), defined as the time from enrollment to the first occurrence of locoregional recurrence; distant metastasis-free survival (DMFS), defined as the time from randomization to the first occurrence of distant metastasis; objective response rate (ORR), defined as the proportion of patients achieving complete response (CR) or partial response (PR), assessed at 2 weeks after completion of induction chemotherapy and at 3 months after completion of radiotherapy; incidence of grade <3 acute toxicities; and incidence and severity of late treatment-related toxicities assessed according to CTCAE version 5.0.Quality of life will be evaluated using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30, version 3.0) and the Head and Neck Cancer-specific module QLQ-H\&N35 (version 1.0), administered at baseline, at the end of treatment, and during follow-up visits.
The trial aims to determine whether IMPT can reduce treatment-related toxicities while maintaining or improving disease control and survival outcomes compared with IMRT.
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Being tested
- Intensity-Modulated Proton Therapy (IMPT), Intensity-Modulated Radiation Therapy (IMRT), Cisplatin, Toripalimab
- Keywords
- Proton Therapy, IMPT, Intensity-Modulated Proton Therapy, Nasopharyngeal Carcinoma, Chemoradiotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity-Modulated Proton Therapy (IMPT)Radiation
Participants assigned to this arm receive intensity-modulated proton therapy (IMPT) according to the protocol-defined dose and fractionation schedule. Radiotherapy is delivered using the same target delineation and prescription principles as IMRT, with dose converted to Gy(RBE) for proton therapy. IMPT is administered concurrently with cisplatin-based chemotherapy and toripalimab as specified in the study protocol.
Intensity-Modulated Radiation Therapy (IMRT)Radiation
Participants assigned to this arm receive intensity-modulated radiation therapy (IMRT) according to the protocol-defined dose and fractionation schedule. Radiotherapy is delivered to the primary tumor and involved lymph nodes following the target delineation and prescription principles specified in the study protocol. IMRT is administered concurrently with cisplatin-based chemotherapy and toripalimab, consistent with the protocol.
CisplatinDrug
Cisplatin is administered during induction chemotherapy and concurrent chemoradiotherapy as specified in the protocol: 80 mg/m² IV on Day 1 every 21 days for 3 cycles during induction (GP regimen), and 100 mg/m² IV on Day 1 and Day 22 for 2 cycles during concurrent chemoradiotherapy.
ToripalimabBiological
Toripalimab 240 mg is administered every 3 weeks during induction, concurrent chemoradiotherapy, and maintenance therapy for a total of 12 cycles unless disease progression or unacceptable toxicity occurs.
| Study group | Role | What they receive |
|---|---|---|
| IMPT Arm | Experimental | Participants assigned to this arm receive intensity-modulated proton therapy (IMPT). Radiotherapy is delivered according to the protocol-defined dose and fractionation schedule, using the same target delineation and prescription principles as IMRT, with dose converted to Gy(RBE) for proton therapy. IMPT treatment is administered concurrently with cisplatin-based chemotherapy and toripalimab as specified in the study protocol. Receives: Radiation: Intensity-Modulated Proton Therapy (IMPT); Drug: Cisplatin; Biological: Toripalimab |
| IMRT Arm | Active comparator | Participants assigned to this arm receive intensity-modulated photon radiotherapy (IMRT) according to the protocol-defined dose and fractionation schedule. Radiotherapy is delivered to the primary tumor and involved lymph nodes following the target delineation and prescription principles specified in the study protocol. IMRT is administered concurrently with cisplatin-based chemotherapy and toripalimab, consistent with the protocol. Receives: Radiation: Intensity-Modulated Radiation Therapy (IMRT); Drug: Cisplatin; Biological: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-related grade ≥3 acute toxicities
The proportion of patients who experience treatment-related grade ≥3 acute toxicities, defined as adverse events occurring from the start of radiotherapy to 90 days after completion of radiotherapy, assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and Radiation Therapy Oncology Group (RTOG) criteria. Ototoxicity (hearing loss or tinnitus), if present, will additionally be evaluated using the American Speech-Language-Hearing Association (ASHA, 1994) significant change criteria.
Measured: From the start of radiotherapy to 90 days after completion of radiotherapy
3-year Progression-Free Survival (PFS) Rate
Defined as the proportion of participants who remain alive and progression-free at 3 years after randomization, with progression-free survival events defined as disease progression or death from any cause, whichever occurs first.
Measured: 3 years
Secondary outcomes (8)
Overall Survival (OS)
Defined as the time interval from randomization to death due to any cause.
Measured: 3 years
Locoregional Recurrence-Free Survival (LRRFS)
Defined as the time from randomization to the date of first locoregional relapse.
Measured: 3 years
Distant Metastasis-Free Survival (DMFS)
Defined as the time interval from randomization to the date of first distant metastasis.
Measured: 3 years
Objective Response Rate (ORR)
Defined as the proportion of participants who achieve a complete response (CR) or partial response (PR). Tumor response will be evaluated 2 weeks after completion of induction chemotherapy and 3 months after completion of radiotherapy.
Measured: 2 weeks after induction chemotherapy and 3 months after completion of radiotherapy
Incidence of Grade <3 Acute Treatment-Related Toxicities
The proportion of participants who experience treatment-related acute adverse events of grade <3. Acute toxicities include anemia, leukopenia, neutropenia, nausea, oral mucositis, anorexia, xerostomia, dermatitis/skin inflammation, fatigue, vomiting, weight loss, and hearing loss.
Measured: From the start of radiotherapy to 90 days after completion of radiotherapy
Incidence of treatment-related late toxicities
The proportion of patients who experience treatment-related late toxicities occurring more than 90 days after completion of radiotherapy, assessed according to CTCAE version 5.0 and RTOG late radiation morbidity scoring criteria.
Measured: From 90 days after completion of radiotherapy up to 3 years
Score of quality of life according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30, version 3.0). The QLQ-C30 consists of multi-item functional scales, symptom scales, and a global health status/quality of life scale. All scale scores range from 0 to 100. For functional scales and global health status, higher scores indicate better functioning or quality of life, whereas for symptom scales, higher scores indicate worse symptom burden.Assessments will be performed before treatment, during treatment, and after completion of treatment.
Measured: Up to 3 years
Score of quality of life according to the EORTC Quality of Life Questionnaire Head and Neck Module (QLQ-H&N35)
Head and neck cancer-specific quality of life will be evaluated using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Head and Neck Module (QLQ-H\&N35).The QLQ-H\&N35 is a disease-specific module designed to assess symptoms and functional impairments related to head and neck cancer and its treatment. All scale scores range from 0 to 100, with higher scores indicating worse symptom severity or functional impairment.Assessments will be conducted before treatment, during treatment, and after completion of treatment.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start15 Dec 2025 (estimated)
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Carcinoma (NPC)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized in a 1:1 ratio to receive intensity-modulated proton therapy (IMPT) or intensity-modulated photon radiotherapy (IMRT) using a parallel-group design.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Man Hu
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Cancer Hospital and Institute
- Responsible party
- Sponsor-investigator, Man Hu, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340515
- Sponsor's protocol ID
- 2025XH13
- Status last verified
- Nov 2025
- First submitted
- 9 Dec 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open-Label, Multicenter Phase III Clinical Study Comparing Intensity-Modulated Proton Therapy and Intensity-Modulated Photon Radiotherapy in Locally Advanced Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT07340515
- Acronym / sponsor ID
- 2025XH13
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Keywords
- Proton Therapy, IMPT, Intensity-Modulated Proton Therapy, Nasopharyngeal Carcinoma, Chemoradiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Man HuUniversity, hospital or other
- Collaborators
- Shandong Cancer Hospital and Institute
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 14 Jan 2026 (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 multicenter, open-label, randomized Phase III trial evaluates intensity-modulated proton therapy (IMPT) versus intensity-modulated photon radiotherapy (IMRT) in patients with newly diagnosed, high-risk, locoregionally advanced nasopharyngeal carcinoma.
All patients receive induction chemotherapy followed by concurrent chemoradiotherapy combined with immunotherapy and are randomized 1:1 to IMPT or IMRT during the concurrent treatment phase.
The primary endpoints are the incidence of grade ≥3 acute treatment-related toxicities and the 3-year progression-free survival (PFS) rate. Secondary endpoints include overall survival, locoregional relapse-free survival, distant metastasis-free survival, objective response rate, late toxicities, and quality of life.
Detailed description
This is a multicenter, open-label, randomized Phase III clinical trial designed to compare the safety and efficacy of intensity-modulated proton therapy (IMPT) versus intensity-modulated photon radiotherapy (IMRT) in patients with newly diagnosed, high-risk, locoregionally advanced nasopharyngeal carcinoma.
Eligible patients are adults aged 18 to 70 years with histologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO type II or III) and clinical stage T4 or N3 disease without distant metastasis (M0), according to the AJCC staging system.
All enrolled patients will receive three cycles of induction chemotherapy consisting of gemcitabine plus cisplatin. This will be followed by concurrent chemoradiotherapy combined with immunotherapy. During the concurrent treatment phase, patients will be randomized in a 1:1 ratio to receive either IMPT or IMRT, delivered according to protocol-defined target delineation, dose prescription, and fractionation schedules.
The first primary endpoint is the incidence of grade ≥3 acute treatment-related toxicities, defined as treatment-related adverse events of grade 3 or higher occurring from the initiation of radiotherapy to 90 days after completion of radiotherapy. Toxicities will be graded according to CTCAE version 5.0 and RTOG criteria. Ototoxicity, including hearing loss or tinnitus, will be further evaluated using the ASHA (1994) significant change criteria for pure-tone audiometry.The second primary endpoint is the 3-year progression-free survival (PFS) rate, defined as the proportion of patients who remain alive without documented disease progression within 3 years after randomization. Disease progression is defined as locoregional recurrence, distant metastasis, or death from any cause, whichever occurs first.
Secondary endpoints include overall survival (OS), defined as the time from randomization to death from any cause; locoregional relapse-free survival (LRRFS), defined as the time from enrollment to the first occurrence of locoregional recurrence; distant metastasis-free survival (DMFS), defined as the time from randomization to the first occurrence of distant metastasis; objective response rate (ORR), defined as the proportion of patients achieving complete response (CR) or partial response (PR), assessed at 2 weeks after completion of induction chemotherapy and at 3 months after completion of radiotherapy; incidence of grade <3 acute toxicities; and incidence and severity of late treatment-related toxicities assessed according to CTCAE version 5.0.Quality of life will be evaluated using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30, version 3.0) and the Head and Neck Cancer-specific module QLQ-H\&N35 (version 1.0), administered at baseline, at the end of treatment, and during follow-up visits.
The trial aims to determine whether IMPT can reduce treatment-related toxicities while maintaining or improving disease control and survival outcomes compared with IMRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized in a 1:1 ratio to receive intensity-modulated proton therapy (IMPT) or intensity-modulated photon radiotherapy (IMRT) using a parallel-group design.
| Arm | Type | Receives |
|---|---|---|
| IMPT Arm | Experimental | Radiation: Intensity-Modulated Proton Therapy (IMPT), Drug: Cisplatin, Biological: ToripalimabParticipants assigned to this arm receive intensity-modulated proton therapy (IMPT). Radiotherapy is delivered according to the protocol-defined dose and fractionation schedule, using the same target delineation and prescription principles as IMRT, with dose converted to Gy(RBE) for proton therapy. IMPT treatment is administered concurrently with cisplatin-based chemotherapy and toripalimab as specified in the study protocol. |
| IMRT Arm | Active comparator | Radiation: Intensity-Modulated Radiation Therapy (IMRT), Drug: Cisplatin, Biological: ToripalimabParticipants assigned to this arm receive intensity-modulated photon radiotherapy (IMRT) according to the protocol-defined dose and fractionation schedule. Radiotherapy is delivered to the primary tumor and involved lymph nodes following the target delineation and prescription principles specified in the study protocol. IMRT is administered concurrently with cisplatin-based chemotherapy and toripalimab, consistent with the protocol. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 to 70 years
- Histologically confirmed nasopharyngeal carcinoma (WHO type II or III)
- High-risk locoregionally advanced disease defined as clinical stage T4 or N3, M0, according to the AJCC staging system
- No prior anti-tumor therapy for nasopharyngeal carcinoma, including radiotherapy, chemotherapy, targeted therapy, or immunotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Key exclusion criteria (7 listed)
- Evidence of distant metastasis (M1 disease)
- Prior radiotherapy, chemotherapy, targeted therapy, or immunotherapy for nasopharyngeal carcinoma
- Active autoimmune disease requiring systemic therapy
- Uncontrolled infection or severe comorbidities that may affect treatment tolerance
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Intensity-Modulated Proton Therapy (IMPT)Participants assigned to this arm receive intensity-modulated proton therapy (IMPT) according to the protocol-defined dose and fractionation schedule. Radiotherapy is delivered using the same target delineation and prescription principles as IMRT, with dose converted to Gy(RBE) for proton therapy. IMPT is administered concurrently with cisplatin-based chemotherapy and toripalimab as specified in the study protocol. | Radiation | IMPT Arm |
| Intensity-Modulated Radiation Therapy (IMRT)Participants assigned to this arm receive intensity-modulated radiation therapy (IMRT) according to the protocol-defined dose and fractionation schedule. Radiotherapy is delivered to the primary tumor and involved lymph nodes following the target delineation and prescription principles specified in the study protocol. IMRT is administered concurrently with cisplatin-based chemotherapy and toripalimab, consistent with the protocol. | Radiation | IMRT Arm |
| CisplatinCisplatin is administered during induction chemotherapy and concurrent chemoradiotherapy as specified in the protocol: 80 mg/m² IV on Day 1 every 21 days for 3 cycles during induction (GP regimen), and 100 mg/m² IV on Day 1 and Day 22 for 2 cycles during concurrent chemoradiotherapy. | Drug | IMPT Arm, IMRT Arm |
| ToripalimabToripalimab 240 mg is administered every 3 weeks during induction, concurrent chemoradiotherapy, and maintenance therapy for a total of 12 cycles unless disease progression or unacceptable toxicity occurs. | Biological | IMPT Arm, IMRT Arm |
Primary outcome
Incidence of treatment-related grade ≥3 acute toxicities
Time frame: From the start of radiotherapy to 90 days after completion of radiotherapy
The proportion of patients who experience treatment-related grade ≥3 acute toxicities, defined as adverse events occurring from the start of radiotherapy to 90 days after completion of radiotherapy, assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and Radiation Therapy Oncology Group (RTOG) criteria. Ototoxicity (hearing loss or tinnitus), if present, will additionally be evaluated using the American Speech-Language-Hearing Association (ASHA, 1994) significant change criteria.
3-year Progression-Free Survival (PFS) Rate
Time frame: 3 years
Defined as the proportion of participants who remain alive and progression-free at 3 years after randomization, with progression-free survival events defined as disease progression or death from any cause, whichever occurs first.
8 secondary outcomes
Overall Survival (OS)
Time frame: 3 years
Locoregional Recurrence-Free Survival (LRRFS)
Time frame: 3 years
Distant Metastasis-Free Survival (DMFS)
Time frame: 3 years
Objective Response Rate (ORR)
Time frame: 2 weeks after induction chemotherapy and 3 months after completion of radiotherapy
Incidence of Grade <3 Acute Treatment-Related Toxicities
Time frame: From the start of radiotherapy to 90 days after completion of radiotherapy
Incidence of treatment-related late toxicities
Time frame: From 90 days after completion of radiotherapy up to 3 years
Score of quality of life according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
Time frame: Up to 3 years
Score of quality of life according to the EORTC Quality of Life Questionnaire Head and Neck Module (QLQ-H&N35)
Time frame: Up to 3 years
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 14 Jan 2026.
- 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.
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Jinan, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intensity-Modulated Proton Therapy (IMPT), Intensity-Modulated Radiation Therapy (IMRT) and Cisplatin in people with Nasopharyngeal Carcinoma (NPC), run by Man Hu 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 14 Jan 2026. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-related grade ≥3 acute toxicities (time frame: From the start of radiotherapy to 90 days after completion of radiotherapy). The study lists 2 primary outcomes in all. 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 14 Jan 2026.