Head and Neck Cancer
Conditions
Keywords
Proton Re-Irradiation, 17-300
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.
Interventions
RADIATIONconventionally fractionated full dose re-irradiation
re-irradiation \[60-70 Gy (RBE) in 2 Gy (RBE) fractions
RADIATIONhypofractionated 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).
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| locoregional recurrence-free | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNancy Lee, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed