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Proton Re-Irradiation for Recurrent Head and Neck Cancer

Primary Purpose

Head and Neck Cancer

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
conventionally fractionated full dose re-irradiation
hypofractionated palliative re-irradiation
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Proton Re-Irradiation, 17-300

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Baptist Alliance MCI
  • Memorial Sloan Kettering Basking Ridge
  • Memorial Sloan Kettering Monmouth
  • Memorial Sloan Kettering Bergen
  • Memorial Sloan Kettering Commack
  • Memorial Sloan Kettering Westchester
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Rockville Centre
  • Memorial Sloan Kettering Nassau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

fractionated full dose re-irradiation

hypofractionated palliative re-irradiation

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 11, 2017
Last Updated
October 9, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03217188
Brief Title
Proton Re-Irradiation for Recurrent Head and Neck Cancer
Official Title
A Phase II Study of Proton Re-Irradiation for Recurrent Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 10, 2017 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
Proton Re-Irradiation, 17-300

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fractionated full dose re-irradiation
Arm Type
Experimental
Arm Title
hypofractionated palliative re-irradiation
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
conventionally fractionated full dose re-irradiation
Intervention Description
re-irradiation [60-70 Gy (RBE) in 2 Gy (RBE) fractions
Intervention Type
Radiation
Intervention Name(s)
hypofractionated palliative re-irradiation
Intervention Description
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).
Primary Outcome Measure Information:
Title
locoregional recurrence-free
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Lee, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baptist Alliance MCI
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Memorial Sloan Kettering Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
Memorial Sloan Kettering Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Rockville Centre
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
Memorial Sloan Kettering Nassau
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

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Proton Re-Irradiation for Recurrent Head and Neck Cancer

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