Head and Neck CancerPhase 2NCT03217188
Proton Re-Irradiation for Recurrent Head and Neck Cancer
A Phase 2 study testing conventionally fractionated full dose re-irradiation and hypofractionated palliative re-irradiation in people with Head and Neck Cancer, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.
Trial summary
The purpose of this study is to evaluate the tumor control and the side effects of using proton therapy for head and neck cancer that has come back. 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?
- conventionally fractionated full dose re-irradiation and hypofractionated palliative re-irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 9 sitesUnited States
- Study dates
- 10 Jul 2017to 18 Mar 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient willing and able to provide written informed consent
- Age ≥18 years at the time of consent
- Pathologically confirmed diagnosis of a recurrent or a new primary head and neck cancer
- A history of prior radiation to the head and neck (>/= 40 Gy, in 2 Gy/fraction equivalent)
- The recurrent or the second primary tumor is unresectable, the patient elects against surgical resection; patients who underwent surgery who has indications for postoperative radiation therapy is also eligible
- Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months after treatment Note: Patient with <6 months of life expectancy will be treated with palliative QUAD shot radiotherapy and those with > 6 months of life expectancy will be treated with conventionally fractionated full dose re-irradiation approach. Additional other factors determining which patients will be treated with Quad Shot therapy rather than full dose are if the patients have poor performance status, bulky or diffuse disease, significant medical co-morbidities, and significant metastatic disease burden.
Who cannot join
- Women who are pregnant or lactating
- Inability to comply with study and/or follow-up procedures
- <6 months between completion of prior RT and initiation of reirradiation using proton therapy
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
Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, 11570
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
About this study
Official title: A Phase II Study of Proton Re-Irradiation for Recurrent Head and Neck Cancer
The purpose of this study is to evaluate the tumor control and the side effects of using proton therapy for head and neck cancer that has come back.
- Conditions
- Head and Neck Cancer
- Being tested
- conventionally fractionated full dose re-irradiation, hypofractionated palliative re-irradiation
- Keywords
- Proton Re-Irradiation, 17-300
- 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.
conventionally fractionated full dose re-irradiationRadiation
re-irradiation [60-70 Gy (RBE) in 2 Gy (RBE) fractions
hypofractionated palliative re-irradiationRadiation
course or a hypofractionated palliative re-irradiation "Quad Shot" course (3.7 Gy (RBE) twice daily x 2 days, followed by a 4 week break [+/- 2 weeks], repeated up to 4 cycles).
| Study group | Role | What they receive |
|---|---|---|
| fractionated full dose re-irradiation | Experimental | Not described Receives: Radiation: conventionally fractionated full dose re-irradiation |
| hypofractionated palliative re-irradiation | Experimental | Not described Receives: Radiation: hypofractionated palliative re-irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
locoregional recurrence-free
Locoregional recurrence includes events of local and/or regional recurrence, or death due to any cause. Patients who are lost to follow-up without any event may be removed from the protocol at the discretion of the principal investigator.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start10 Jul 2017
- Primary completion18 Mar 2026
- Study completion18 Mar 2026
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a phase II study evaluating proton reirradiation for patients who have a recurrent or a second primary head and neck cancer.
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy Lee, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217188
- Sponsor's protocol ID
- 17-300
- Status last verified
- Mar 2026
- First submitted
- 11 Jul 2017
- Last updated
- 23 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Dee EC, Barker CA, Kalman NS, Wu Y, White C, Zhang Z, Lin H, Gelblum DY, Yu Y, Kang JJ, Tsai CJ, Zakeri K, Chen L, McBride SM, Shamseddine A, Michel LS, Dunn LA, Ho AL, Cohen MA, Ganly I, Cracchiolo JR, Wong RJ, Romesser PB, Riaz N, Sherman EJ, Lee NY. A multicenter, prospective, phase 2 trial on proton re-irradiation for patients with previously treated head and neck cancer. Cancer. 2026 Nov 1;132(21):e70643. doi: 10.1002/cncr.70643.
PubMed 42963935
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Proton Re-Irradiation for Recurrent Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT03217188
- Acronym / sponsor ID
- 17-300
- Conditions
- Head and Neck Cancer
- Keywords
- Proton Re-Irradiation, 17-300
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 18 Mar 2026 (actual)
- Study completion
- 18 Mar 2026 (actual)
- First posted
- 14 Jul 2017 (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 evaluate the tumor control and the side effects of using proton therapy for head and neck cancer that has come back.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a phase II study evaluating proton reirradiation for patients who have a recurrent or a second primary head and neck cancer.
| Arm | Type | Receives |
|---|---|---|
| fractionated full dose re-irradiation | Experimental | Radiation: conventionally fractionated full dose re-irradiation |
| hypofractionated palliative re-irradiation | Experimental | Radiation: hypofractionated palliative re-irradiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient willing and able to provide written informed consent
- Age ≥18 years at the time of consent
- Pathologically confirmed diagnosis of a recurrent or a new primary head and neck cancer
- A history of prior radiation to the head and neck (>/= 40 Gy, in 2 Gy/fraction equivalent)
- The recurrent or the second primary tumor is unresectable, the patient elects against surgical resection; patients who underwent surgery who has indications for postoperative radiation therapy is also eligible
Key exclusion criteria (3 listed)
- Women who are pregnant or lactating
- Inability to comply with study and/or follow-up procedures
- <6 months between completion of prior RT and initiation of reirradiation using proton therapy
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 |
|---|---|---|
| conventionally fractionated full dose re-irradiationre-irradiation [60-70 Gy (RBE) in 2 Gy (RBE) fractions | Radiation | fractionated full dose re-irradiation |
| hypofractionated palliative re-irradiationcourse or a hypofractionated palliative re-irradiation "Quad Shot" course (3.7 Gy (RBE) twice daily x 2 days, followed by a 4 week break [+/- 2 weeks], repeated up to 4 cycles). | Radiation | hypofractionated palliative re-irradiation |
Primary outcome
locoregional recurrence-free
Time frame: 12 months
Locoregional recurrence includes events of local and/or regional recurrence, or death due to any cause. Patients who are lost to follow-up without any event may be removed from the protocol at the discretion of the principal investigator.
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 23 Mar 2026.
- Derived from this study: PubMed 42963935Dee EC, Barker CA, Kalman NS, Wu Y, White C, Zhang Z, Lin H, Gelblum DY, Yu Y, Kang JJ, Tsai CJ, Zakeri K, Chen L, McBride SM, Shamseddine A, Michel LS, Dunn LA, Ho AL, Cohen MA, Ganly I, Cracchiolo JR, Wong RJ, Romesser PB, Riaz N, Sherman EJ, Lee NY. A multicenter, prospective, phase 2 trial on proton re-irradiation for patients with previously treated head and neck cancer. Cancer. 2026 Nov 1;132(21):e70643. doi: 10.1002/cncr.70643.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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 conventionally fractionated full dose re-irradiation and hypofractionated palliative re-irradiation 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 6 inclusion and 3 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 23 Mar 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?
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?
locoregional recurrence-free (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 NCT03217188, 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 23 Mar 2026.