Status:
COMPLETED
A Prospective Study of Daily Adaptive Radiotherapy to Better Organ-at-Risk Doses in Head and Neck Cancer
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Varian Medical Systems has recently deployed a completely novel radiation treatment system called EthosTM, a first-of-its-kind system that allows for daily adapative radiotherapy (DART), such that the...
Detailed Description
IMRT with daily cone-beam computed tomography (CBCT) set up is the current recommended radiation technique for head and neck squamous cell carcinoma. The conformality of IMRT has made it possible to r...
Eligibility Criteria
Inclusion
- Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx, larynx, or hypopharynx. Squamous cell carcinoma of unknown primary is not allowed.
- Patients must have clinically or radiographically evident measureable disease at the primary site and/or nodal stations. Diagnostic lymph node excision (\< 2 nodes) is also allowable.
- Patients may undergo a diagnostic or therapeutic transoral resection for a T1-2 tonsil or base of tongue cancer.
- Clinical stage I-IVB (AJCC, 7th edition); stages I-II glottic cancer are excluded
- Age ≥ 18 years.
- ECOG Performance Status 0-2
- Negative serum or urine pregnancy test within 2 weeks before registration for women of childbearing potential.
- Neck CT and/or neck MRI, and PET-CT (at least skull-to-thigh).
- Ability to understand and the willingness to sign a written informed consent.
- All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
Exclusion
- Distant metastasis.
- Inability to undergo PET-CT.
- Stage I and II glottic carcinoma.
- Gross total excision of both the primary and nodal disease.
- Synchronous non-skin cancer primaries outside of the oropharynx, larynx, and hypopharynx except for low- and intermediate-risk prostate cancer and synchronous well-differentiated thyroid cancer; in the latter case, surgery may occur before or after treatment, provided all other eligibility criteria are met.
- Prior invasive malignancy with an expected disease-free interval of less than 3 years.
- Prior systemic chemotherapy for the study cancer; prior chemotherapy for a remote cancer is allowable
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields.
- Subjects may not be receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the chemotherapy agents in this study (if necessary).
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements
- pregnant or nursing women
- History of severe immunosuppression, including HIV, and organ or autologous or allogeneic stem cell transplant.
Key Trial Info
Start Date :
February 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 4 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04883281
Start Date
February 23 2022
End Date
September 4 2024
Last Update
September 19 2024
Active Locations (1)
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1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390