Clinical trial NCT03217188: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Head and Neck Cancer
Keywords: Proton Re-Irradiation
17-300
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: locoregional recurrence-free
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baptist Alliance MCI
state: Florida
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Rockville Centre
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Nancy Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: