Head and Neck CancerPhase 2NCT02923570
Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Head and Neck Cancer
A Phase 2 study testing Photon intensity modulated radiation therapy (IMRT) and Proton beam radiotherapy (PBRT) in people with Head and Neck Cancer, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.
Trial summary
Compared to IMRT, PBRT is thought to give less radiation exposure to the surrounding healthy tissues. It is possible that side effect rates with PBRT will be lower or the same compared to IMRT, but this has not been well studied to date. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Photon intensity modulated radiation therapy (IMRT) and Proton beam radiotherapy (PBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 9 sitesUnited States
- Study dates
- 3 Oct 2016to Oct 2027
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18.
- Histopathologically confirmed diagnosis of one the following cancer types:
- Salivary gland cancer
- Skin cancer
- Melanoma
- HNSCC that require ipsilateral radiation
Show all 9Show fewer
- Patients must be a candidate for ipsilateral radiation therapy.
- Karnofsky performance status ≥70.
- Negative pregnancy test for women of childbearing potential (<51 years of age) as per institutional policy.
Who cannot join
- Any prior head or neck irradiation.
- Physician recommendation of bilateral neck radiation.
- Non-resectable disease
- Physician recommendation of mucosal radiation
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Baptist Alliance MCI
Miami, Florida, 33143
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Mayo Clinic
Rochester, Minnesota, 55905
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
About this study
Official title: A Phase II Randomized Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Unilateral Head and Neck Cancer
Compared to IMRT, PBRT is thought to give less radiation exposure to the surrounding healthy tissues. It is possible that side effect rates with PBRT will be lower or the same compared to IMRT, but this has not been well studied to date. Although both of these radiation therapies have been used in the past to treat head and neck cancer, this research study will compare the effects of these two different radiation treatment modalities with each other to see whether PBRT is better, the same or worse than IMRT.
- Conditions
- Head and Neck Cancer
- Being tested
- Photon intensity modulated radiation therapy (IMRT), Proton beam radiotherapy (PBRT)
- Keywords
- proton-beam radiation therapy (PBRT), intensity-modulated radiation therapy (IMRT), 16-1416
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photon intensity modulated radiation therapy (IMRT)Radiation
Photon intensity modulated radiation therapy (IMRT) to standard dose of 60-66Gy in standard 2 Gy per fraction.
Proton beam radiotherapy (PBRT)Radiation
Proton beam radiotherapy (PBRT) to standard dose of 60-66Gy in standard 2 Gy per fraction.
| Study group | Role | What they receive |
|---|---|---|
| Photon intensity modulated radiation therapy (IMRT) | Experimental | IMRT to standard dose of 60-66Gy Receives: Radiation: Photon intensity modulated radiation therapy (IMRT) |
| Proton beam radiotherapy (PBRT) | Experimental | PBRT to standard dose of 60-66Gy Receives: Radiation: Proton beam radiotherapy (PBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with grade 2 or greater acute mucositis
via the CTCAE v4.0.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study start3 Oct 2016
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (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 Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a phase II randomized two-arm trial comparing proton-beam radiation therapy (PBRT) with photon- based intensity-modulated radiation therapy (IMRT) for cancers in the head and neck region requiring ipsilateral radiation.
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Nancy Lee, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923570
- Sponsor's protocol ID
- 16-1416
- Status last verified
- Nov 2026
- First submitted
- 3 Oct 2016
- Last updated
- 5 Nov 2026
- Results posted
- No
Publications
Dee EC, Kalman NS, Ma DJ, Lester SC, Zhang Z, Gelblum D, Yu Y, Chen L, McBride SM, Riaz N, Mueller BA, Shamseddine A, Zakeri K, Kang JJ, Tsai CJ, Wu Y, Mah D, Sine K, Shim A, Lin H, Ho A, Wong RJ, Romesser PB, Barker CA, Lee NY. A phase II randomized study of proton therapy vs intensity-modulated radiation therapy in patients with unilateral head and neck cancer. J Natl Cancer Inst. 2026 Sep 3:djag257. doi: 10.1093/jnci/djag257. Online ahead of print.
PubMed 42690689
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Unilateral Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT02923570
- Acronym / sponsor ID
- 16-1416
- Conditions
- Head and Neck Cancer
- Keywords
- proton-beam radiation therapy (PBRT), intensity-modulated radiation therapy (IMRT), 16-1416
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Mayo Clinic
- Study start
- 3 Oct 2016 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 4 Oct 2016 (estimated)
- 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.
Compared to IMRT, PBRT is thought to give less radiation exposure to the surrounding healthy tissues. It is possible that side effect rates with PBRT will be lower or the same compared to IMRT, but this has not been well studied to date. Although both of these radiation therapies have been used in the past to treat head and neck cancer, this research study will compare the effects of these two different radiation treatment modalities with each other to see whether PBRT is better, the same or worse than IMRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a phase II randomized two-arm trial comparing proton-beam radiation therapy (PBRT) with photon- based intensity-modulated radiation therapy (IMRT) for cancers in the head and neck region requiring ipsilateral radiation.
| Arm | Type | Receives |
|---|---|---|
| Photon intensity modulated radiation therapy (IMRT) | Experimental | Radiation: Photon intensity modulated radiation therapy (IMRT)IMRT to standard dose of 60-66Gy |
| Proton beam radiotherapy (PBRT) | Experimental | Radiation: Proton beam radiotherapy (PBRT)PBRT to standard dose of 60-66Gy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age greater than or equal to 18.
- Histopathologically confirmed diagnosis of one the following cancer types:
- HNSCC that require ipsilateral radiation
- Patients must be a candidate for ipsilateral radiation therapy.
- Karnofsky performance status ≥70.
Key exclusion criteria (4 listed)
- Any prior head or neck irradiation.
- Physician recommendation of bilateral neck radiation.
- Non-resectable disease
- Physician recommendation of mucosal radiation
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 |
|---|---|---|
| Photon intensity modulated radiation therapy (IMRT)Photon intensity modulated radiation therapy (IMRT) to standard dose of 60-66Gy in standard 2 Gy per fraction. | Radiation | Photon intensity modulated radiation therapy (IMRT) |
| Proton beam radiotherapy (PBRT)Proton beam radiotherapy (PBRT) to standard dose of 60-66Gy in standard 2 Gy per fraction. | Radiation | Proton beam radiotherapy (PBRT) |
Primary outcome
number of patients with grade 2 or greater acute mucositis
Time frame: 1 year
via the CTCAE v4.0.
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 5 Nov 2026.
- Derived from this study: PubMed 42690689Dee EC, Kalman NS, Ma DJ, Lester SC, Zhang Z, Gelblum D, Yu Y, Chen L, McBride SM, Riaz N, Mueller BA, Shamseddine A, Zakeri K, Kang JJ, Tsai CJ, Wu Y, Mah D, Sine K, Shim A, Lin H, Ho A, Wong RJ, Romesser PB, Barker CA, Lee NY. A phase II randomized study of proton therapy vs intensity-modulated radiation therapy in patients with unilateral head and neck cancer. J Natl Cancer Inst. 2026 Sep 3:djag257. doi: 10.1093/jnci/djag257. Online ahead of print.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Nancy Lee, MD principal investigator
Memorial Sloan Kettering Cancer Center
9 sites 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 intensity modulated radiation therapy (IMRT) and Proton beam radiotherapy (PBRT) in people with Head and Neck Cancer, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.
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 9 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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?
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?
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 patients with grade 2 or greater acute mucositis (time frame: 1 year). 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 NCT02923570, 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 5 Nov 2026.