Nasopharyngeal CarcinomaPhase 2NCT04528394
Proton Versus Photon Radiotherapy for Nasopharyngeal Carcinoma
A Phase 2 study testing Photon, Proton and Carbon ion in people with Nasopharyngeal Carcinoma, run by Shanghai Proton and Heavy Ion Center at 1 site in China.
Trial summary
The purpose of this study is to compare the toxicity and therapeutic efficacy of proton or photon combined with carbon ion radiotherapy for newly diagnosed nasopharyngeal carcinoma.Participants will be randomized to 2 arms. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Photon, Proton and Carbon ion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 29 Apr 2019to 30 Jun 2024
- 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
Who may be able to join
- Pathologically confirmed Nasopharyngeal carcinoma(WHO II/III type).
- Age ≥ 18 and ≤ 70 years of age.
- Eastern Cooperative Oncology Group score: 0-1.
- Adequate laboratory values within 30 dyas of enrollment to study defined as follows: 1) neutrophil > 2000/mm^3; 2) platelet > 100,000/mm^3; 3) total bilirubin < 1.5mg/dl; 4) alanine aminotransferase/aspartate aminotransferase < 1.5 upper limit of normal; 5) SCr < 1.5mg/dl; creatinine clearance rate > 60ml/min.
- Willing to accept adequate contraception for women with childbearing potential.
- Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial.
Who cannot join
- Presence of distant metastasis.
- Received radiotherapy for head and neck before.
- Received surgery(except for biopsy) for primary lesion or cervical lymph node.
- Previous history of malignant tumor (within 5 years) or simultaneous existence of multiple primary tumors.
- Presence of diseases (such as Sjögren syndrome) that may interfere evaluation of xerostomia.
- Accompanied with severe major organ dysfunction.
- Presence of mental disease that may influence the understanding of informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, 201315
About this study
Official title: A Randomized Phase II Trial Evaluating Toxicity and Efficacy Between Proton and Photon for Nasopharyngeal Carcinoma
The purpose of this study is to compare the toxicity and therapeutic efficacy of proton or photon combined with carbon ion radiotherapy for newly diagnosed nasopharyngeal carcinoma.Participants will be randomized to 2 arms. Arm 1, participants received photon combined with carbon ion radiotherapy group, Arm 2, participants received proton combined with carbon ion radiotherapy.
Read the detailed description
The purpose of this study is to compare the toxicity and therapeutic efficacy of photon or proton combined with carbon ion radiotherapy for newly diagnosed nasopharyngeal carcinoma.Participants will be randomized to 2 arms. Arm 1 participants received photon combined with carbon ion radiotherapy (photon: 56 Gy/28 Fx, plus carbon: 15-17.5 gray equivalent [GyE]/5 Fx for boost). Arm 2, participants received proton combined with carbon ion radiotherapy (proton: 56 GyE/28 Fx, plus carbon: 15-17.5 GyE/5 Fx for boost). Adverse events will be documented according to CTCAE v4.03.The response of treatment will be evaluated according to RECIST criteria.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Photon, Proton, Carbon ion
- Keywords
- Nasopharyngeal carcinoma, Intensity-modulated radiation therapy, Proton beam therapy, Carbon-ion radiotherapy, Toxicity, Survival, Disease control
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotonRadiation
Photon combined with Carbon ion in Arm 1
ProtonRadiation
Proton combined with Carbon ion in Arm 2
Carbon ionRadiation
Same dose and fractionation will be used in both arms.
| Study group | Role | What they receive |
|---|---|---|
| Photon combined with Carbon ion | Experimental | The participants received photon: 56 Gy/28 Fx for high-risk area(CTVhigh), 50.4 Gy/28 Fx for lower neck low-risk area(CTVlow), plus carbon ion: 15-17.5 GyE/5 Fx for boost for visible tumors. Receives: Radiation: Photon; Radiation: Carbon ion |
| Proton combined with Carbon ion | Experimental | The participants received proton: 56 GyE/28 Fx for high-risk area(CTVhigh), 50.4 GyE/28 Fx for lower neck low-risk area(CTVlow), plus carbon ion: 15-17.5 GyE/5 Fx for boost for visible tumors. Receives: Radiation: Proton; Radiation: Carbon ion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related Xerostomia (≥Grade 2) as assessed by NCI CTCAE v4.03
CTCAE refers to Common Terminology Criteria for Adverse Events, which is one of the most frequently used criteria for toxicity grading after anti-cancer treatment.
Measured: Xerostomia (≥Grade 2) occurred at 6 months after completion of radiotherapy
Secondary outcomes (6)
Overall survival of all patients
Measured: From randomization to death, a median of 3 years.
Progression-free survival of all patients
Measured: From randomization to death or disease progression, a median of 3 years.
Local control
Measured: From randomization to local failure, a median of 3 years.
Regional control
Measured: From randomization to regional failure, a median of 3 years.
Distant control
Measured: From randomization to distant failure, a median of 3 year.
Treatment-related adverse events as assessed by NCI CTCAE v4.03
Acute and late toxicities induced by radiation therapy other than xerostomia.
Measured: Time interval from start to 3 months after completion of radiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start29 Apr 2019
- Primary completion8 Mar 2022
- Study completion30 Jun 2024
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Proton and Heavy Ion Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiade J. Lu, Shanghai Proton and Heavy Ion Center
- Investigators
- Jiade Lu, MD, Principal investigator, Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528394
- Sponsor's protocol ID
- SPHIC-TR-HNCNS-2019-32
- Status last verified
- Jun 2026
- First submitted
- 24 Aug 2020
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data including baseline characteristics, treatment information and follow-up data on toxicity, survival and disease control will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial Evaluating Toxicity and Efficacy Between Proton and Photon for Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT04528394
- Acronym / sponsor ID
- SPHIC-TR-HNCNS-2019-32
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal carcinoma, Intensity-modulated radiation therapy, Proton beam therapy, Carbon-ion radiotherapy, Toxicity, Survival, Disease control
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Shanghai Proton and Heavy Ion CenterUniversity, hospital or other
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 8 Mar 2022 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 27 Aug 2020 (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.
The purpose of this study is to compare the toxicity and therapeutic efficacy of proton or photon combined with carbon ion radiotherapy for newly diagnosed nasopharyngeal carcinoma.Participants will be randomized to 2 arms. Arm 1, participants received photon combined with carbon ion radiotherapy group, Arm 2, participants received proton combined with carbon ion radiotherapy.
Detailed description
The purpose of this study is to compare the toxicity and therapeutic efficacy of photon or proton combined with carbon ion radiotherapy for newly diagnosed nasopharyngeal carcinoma.Participants will be randomized to 2 arms. Arm 1 participants received photon combined with carbon ion radiotherapy (photon: 56 Gy/28 Fx, plus carbon: 15-17.5 gray equivalent [GyE]/5 Fx for boost). Arm 2, participants received proton combined with carbon ion radiotherapy (proton: 56 GyE/28 Fx, plus carbon: 15-17.5 GyE/5 Fx for boost). Adverse events will be documented according to CTCAE v4.03.The response of treatment will be evaluated according to RECIST criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photon combined with Carbon ion | Experimental | Radiation: Photon, Radiation: Carbon ionThe participants received photon: 56 Gy/28 Fx for high-risk area(CTVhigh), 50.4 Gy/28 Fx for lower neck low-risk area(CTVlow), plus carbon ion: 15-17.5 GyE/5 Fx for boost for visible tumors. |
| Proton combined with Carbon ion | Experimental | Radiation: Proton, Radiation: Carbon ionThe participants received proton: 56 GyE/28 Fx for high-risk area(CTVhigh), 50.4 GyE/28 Fx for lower neck low-risk area(CTVlow), plus carbon ion: 15-17.5 GyE/5 Fx for boost for visible tumors. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pathologically confirmed Nasopharyngeal carcinoma(WHO II/III type).
- Age ≥ 18 and ≤ 70 years of age.
- Eastern Cooperative Oncology Group score: 0-1.
- Adequate laboratory values within 30 dyas of enrollment to study defined as follows: 1) neutrophil > 2000/mm^3; 2) platelet > 100,000/mm^3; 3) total bilirubin < 1.5mg/dl; 4) alanine aminotransferase/aspartate aminotransferase < 1.5 upper limit of normal; 5) SCr < 1.5mg/dl; creatinine clearance rate > 60ml/min.
- Willing to accept adequate contraception for women with childbearing potential.
Key exclusion criteria (7 listed)
- Presence of distant metastasis.
- Received radiotherapy for head and neck before.
- Received surgery(except for biopsy) for primary lesion or cervical lymph node.
- Previous history of malignant tumor (within 5 years) or simultaneous existence of multiple primary tumors.
- Presence of diseases (such as Sjögren syndrome) that may interfere evaluation of xerostomia.
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 |
|---|---|---|
| PhotonPhoton combined with Carbon ion in Arm 1 | Radiation | Photon combined with Carbon ion |
| ProtonProton combined with Carbon ion in Arm 2 | Radiation | Proton combined with Carbon ion |
| Carbon ionSame dose and fractionation will be used in both arms. | Radiation | Photon combined with Carbon ion, Proton combined with Carbon ion |
Primary outcome
Number of participants with treatment-related Xerostomia (≥Grade 2) as assessed by NCI CTCAE v4.03
Time frame: Xerostomia (≥Grade 2) occurred at 6 months after completion of radiotherapy
CTCAE refers to Common Terminology Criteria for Adverse Events, which is one of the most frequently used criteria for toxicity grading after anti-cancer treatment.
6 secondary outcomes
Overall survival of all patients
Time frame: From randomization to death, a median of 3 years.
Progression-free survival of all patients
Time frame: From randomization to death or disease progression, a median of 3 years.
Local control
Time frame: From randomization to local failure, a median of 3 years.
Regional control
Time frame: From randomization to regional failure, a median of 3 years.
Distant control
Time frame: From randomization to distant failure, a median of 3 year.
Treatment-related adverse events as assessed by NCI CTCAE v4.03
Time frame: Time interval from start to 3 months after completion of radiotherapy.
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 24 Jun 2026.
- Individual participant dataSharing planned: Yes. Individual participant data including baseline characteristics, treatment information and follow-up data on toxicity, survival and disease control will be shared.
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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.
Jiade Lu, MD principal investigator
Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC
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 Photon, Proton and Carbon ion in people with Nasopharyngeal Carcinoma, run by Shanghai Proton and Heavy Ion Center 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 6 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: finished, as of the sponsor's last update on 24 Jun 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 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?
Number of participants with treatment-related Xerostomia (≥Grade 2) as assessed by NCI CTCAE v4.03 (time frame: Xerostomia (≥Grade 2) occurred at 6 months after completion of radiotherapy). 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 24 Jun 2026.