Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Proton Re-Irradiation for Recurrent Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03217188
Recruitment Status : Recruiting
First Posted : July 14, 2017
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Radiation: conventionally fractionated full dose re-irradiation Radiation: hypofractionated palliative re-irradiation Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: A Phase II Study of Proton Re-Irradiation for Recurrent Head and Neck Cancer
Actual Study Start Date : July 10, 2017
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: fractionated full dose re-irradiation Radiation: conventionally fractionated full dose re-irradiation
re-irradiation [60-70 Gy (RBE) in 2 Gy (RBE) fractions

Experimental: hypofractionated palliative re-irradiation Radiation: hypofractionated palliative re-irradiation
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 Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03217188


Contacts
Layout table for location contacts
Contact: Nancy Lee, MD 212-639-3341 leen2@mskcc.org
Contact: Oren Cahlon, MD 212-639-5219

Locations
Layout table for location information
United States, Florida
Baptist Alliance MCI Recruiting
Miami, Florida, United States, 33143
Contact: Noah Kalman, MD    786-596-2000      
United States, New Jersey
Memoral Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Nancy Lee, MD    212-639-3341      
Memoral Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Nancy Lee, MD    212-639-3341      
Memorial Sloan Kettering Bergen Recruiting
Montvale, New Jersey, United States, 07645
Contact: Nancy Lee, MD    212-639-3341      
United States, New York
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Nancy Lee, MD    212-639-3341      
Memoral Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Nancy Lee, MD    212-639-3341      
New York Proton Center Not yet recruiting
New York, New York, United States, 10035
Contact: Nancy Lee, MD    212-639-3341      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Nancy Lee, MD    212-639-3341      
Contact: Oren Cahlon, MD    212-639-5219      
Principal Investigator: Nancy Lee, MD         
Memorial Sloan Kettering Rockville Centre Recruiting
Rockville Centre, New York, United States, 11570
Contact: Nancy Lee, MD    212-639-3341      
Memorial Sloan Kettering Nassau Recruiting
Uniondale, New York, United States, 11553
Contact: Nancy Lee, MD    212-639-3341      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Nancy Lee, MD Memorial Sloan Kettering Cancer Center
Additional Information:
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03217188    
Other Study ID Numbers: 17-300
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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
Keywords provided by Memorial Sloan Kettering Cancer Center:
Proton Re-Irradiation
17-300
Additional relevant MeSH terms:
Layout table for MeSH terms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms