NCT03217188

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P75+ for phase_2 head-and-neck-cancer

Timeline
Completed

Started Jul 2017

Longer than P75 for phase_2 head-and-neck-cancer

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 11, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 14, 2017

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2026

Completed
Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

8.7 years

First QC Date

July 11, 2017

Last Update Submit

March 19, 2026

Conditions

Head and Neck Cancer

Keywords

Proton Re-Irradiation17-300

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Study Arms (2)

fractionated full dose re-irradiation

EXPERIMENTAL
Radiation: conventionally fractionated full dose re-irradiation

hypofractionated palliative re-irradiation

EXPERIMENTAL
Radiation: hypofractionated palliative re-irradiation

Interventions

conventionally fractionated full dose re-irradiationRADIATION

re-irradiation \[60-70 Gy (RBE) in 2 Gy (RBE) fractions

fractionated full dose re-irradiation
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).

hypofractionated palliative re-irradiation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Baptist Alliance MCI

Miami, Florida, 33143, United States

Location

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Rockville Centre

Rockville Centre, New York, 11570, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Related Links

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Nancy Lee, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a phase II study evaluating proton reirradiation for patients who have a recurrent or a second primary head and neck cancer.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2017

First Posted

July 14, 2017

Study Start

July 10, 2017

Primary Completion

March 18, 2026

Study Completion

March 18, 2026

Last Updated

March 23, 2026

Record last verified: 2026-03

Locations

US(9)