A Prospective Study of Daily Adaptive Radiotherapy to Better Organ-at-Risk Doses in Head and Neck Cancer

• Status: Not yet recruiting
• Trial end date: 2023-12-15
• Target enrollment: 0
• Participant gender: All

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 treatment for that day can be created on-the-fly based on the patient's current positioning and anatomy. This system is commercially-available and FDA-approved, and UTSW Radiation Oncology has installed two such units. The ability to adjust the dose delivery every day means both that adaptive therapy is possible with every fraction and that the PTV margin can be dramatically reduced/eliminated, since investigators are treating for that day's patient setup. Investigators are therefore proposing a randomized trial using DART with near marginless (ML) setup margins (a 1 mm margin will be retained for intrafractional motion).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Carboplatin; Cetuximab; Paclitaxel

Criteria

Inclusion Criteria:

• Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx, larynx, or hypopharynx.

• clinically or radiographically evident measurable disease at the primary site and/or nodal stations

• 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

• 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.

• Negative serum or urine pregnancy test

• 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.

Exclusion Criteria:

• 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

• Prior invasive malignancy with an expected disease-free interval of less than 3 years.

• Prior systemic chemotherapy for the study cancer;

• 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

• pregnant or nursing women

• History of severe immunosuppression, including HIV, and organ or autologous or allogeneic stem cell transplant.