Radiation Therapy Head and Neck Cancer Clinical Trials
New Patient Appointment or 214-645-8525
The Department of Radiation Oncology at UT Southwestern Medical Center has a multidisciplinary team of physicians, nurses, radiation therapists, speech therapists, and dietitians to provide comprehensive treatment for patients with head and neck cancers. With a brand new facility that opened in May 2021 and state-of-the-art technology optimized for adaptive radiation therapy, patients receive the most precise and personalized radiation therapy available.
In addition, our Department offers opportunities to enroll on novel clinical trials not available elsewhere. We have trials for almost all types of pathology in the head and neck region—each focused on minimizing toxicity, maximizing quality of life, decreasing treatment burden, and/or discovering new combination treatments with radiation therapy.
A brief description of the trials available are listed below. To learn more, watch the videos or call our research team directly at 214-648-1836.
Definitive Radiation Therapy
DARTBOARD: A Randomized Phase II Study of Daily Adaptive Radiotherapy to Better OAR (organs at risk) Doses in Head and Neck Cancer
Background: We have previously performed a prospective study that investigated the impact of significantly shrinking the volume of radiotherapy to a patient’s neck (“involved nodal radiation therapy”), finding excellent quality-of-life outcomes. However, we are continually trying to improve the short- and long-term outcomes of our treatments. Our Department has installed two cutting-edge Ethos adaptive radiotherapy linear accelerators, which allows for daily optimization of the radiation plan. With this type of precision therapy, we are able to significantly reduce “set-up” margins and adjust to the patient’s continually changing anatomy, which should reduce the dose of radiotherapy to normal tissue. However, we do not know whether such a change will improve the patient’s quality of life.
Purpose: To assess the impact of daily adaptive therapy in which the radiation plan is updated each day in real time to the patient’s anatomy and position.
Eligibility: Patients with T1-4, N0-3 oropharynx, larynx, and hypopharynx cancer.
Treatment: Randomized to Arm 1 or 2
- Arm 1: Involved nodal radiation therapy +/- chemotherapy as indicated
- Arm 2: “Marginless” daily adaptive involved nodal radiation therapy +/- chemotherapy as indicated
HYHOPE: A Phase I Study of De-intensified Hypofractionated Radiation Therapy for Human Papilloma Virus-associated Oropharynx Cancer
Background: Human papillomavirus (HPV)-associated oropharyngeal cancer is a uniquely favorable head and neck cancer, and several studies have shown excellent outcomes with reduced doses of treatment. Nevertheless, even these reduced doses of radiotherapy require six weeks to deliver, with six cycles of chemotherapy. We believe that similarly impressive outcomes can be obtained with a shorter regimen of radiation and chemotherapy.
Purpose: To assess the safety of de-escalated radiation therapy for favorable oropharynx cancer (tonsil, base of tongue, soft palate).
Eligibility: Patients with T1-3, N0-2 (except T1-2N0) p16 positive (HPV associated) oropharynx cancer with ≤10 pack-year smoking history.
Treatment: Shortened (hypofractionated) and volume/dose de-intensified radiation therapy delivered in 3 weeks with weekly cisplatin chemotherapy (vs 7-week standard of care radiation therapy).
EA3161: A Phase II/III Randomized Study of Maintenance Nivolumab versus Observation in Patients with Locally Advanced, Intermediate- Risk HPV Positive Oropharynx Squamous Cell Carcinoma (OPSCC)
Background: Although HPV-related head and neck cancer is typically associated with an excellent prognosis, there is still room for improvement for individuals with “intermediate-risk” disease, composed of patients with a significant smoking history or bulkier disease. Immunotherapy, which teaches the body’s immune system to fight the cancer, has been shown to improve survival for patients with metastatic head and neck cancer, and so there is much interest in trying to use immunotherapy to help cure more patients with non-metastatic disease.
Purpose: To assess the role of immunotherapy following standard chemoradiation therapy for higher risk oropharynx cancer (tonsil, base of tongue, soft palate).
Eligibility: Patients with p16 positive (HPV-associated) oropharynx cancer with:
- ≥10 pack-years, stage T1-2N2-3 or T3-4N0-3 or
- <10 pack-years, stage T4N0-3 or T1-3N2-3
Treatment: Randomized to Arm 1 or 2
- Arm 1: Radiation therapy in 7 weeks with cisplatin chemotherapy weekly (standard of care)
- Arm 2: Radiation therapy in 7 weeks with cisplatin chemotherapy weekly followed by nivolumab immunotherapy every 4 weeks for 12 cycles
Post-Operative Radiation Therapy
HYPORT: A Randomized Phase II Study of Hypofractionated Post-operative Radiation Therapy for Head and Neck Squamous Cell Carcinoma
Background: Post-operative radiotherapy has become progressively more tolerable as radiotherapy techniques have improved. However, the treatment can still take 6 weeks to complete, which is a significant treatment burden for many patients and also leads to a long overall treatment time since patients first undergo, and then recover from, surgical resection. Shorter course, or hypofractionated, radiotherapy, has been shown to be equally efficacious and tolerable in other cancer treatments, and we are evaluating whether such shorter treatments can also be used in head and neck cancer.
Purpose: To assess the toxicity and effectiveness of shortened post-operative radiation therapy from 6 weeks to 3 weeks.
Eligibility: Patients with stage I-IVB oral cavity, oropharynx, hypopharynx, or larynx cancer following surgical resection with pathology showing intermediate risk factor(s): T3/4 disease, positive lymph node(s), close margin(s), perineural invasion, and/or lymphovascular invasion.
Treatment: Randomized to Arm 1 or 2
- Arm 1: Post-operative radiation therapy for 6 weeks (standard of care)
- Arm 2: Shortened (hypofractionated) post-operative radiation therapy for 3 weeks
RTOG 1216: A Randomized Phase II/III Trial of Adjuvant Radiation Therapy with Cisplatin, Docetaxel-Cetuximab, or Cisplatin-Atezolizumab in Pathologic High-Risk Squamous Cell Cancer of the Head and Neck
Background: Some patients face a harder prognosis despite high-quality surgical resection. Indeed, individuals whose surgery results in “positive margins” or those who have “extranodal extension” around positive lymph nodes have a higher risk of recurrence. There have been several studies testing whether different chemotherapy treatments will improve the outcome in these conditions, and these different systemic therapy treatments delivered with radiotherapy are the subject of this large, national trial.
Purpose: To assess the effectiveness of novel chemotherapy/immunotherapy combinations with post-operative radiation therapy for high-risk head and neck cancers.
Eligibility: Patients with oral cavity, larynx, hypopharynx, or p16 negative oropharynx cancer following surgical resection with high risk pathologic features including extracapsular nodal extension or positive resection margin(s).
Treatment: Randomized to Arm 1, 2, or 3 in 1:1:2 ratio
- Arm 1: Radiation therapy for 6 weeks with cisplatin chemotherapy weekly (standard of care)
- Arm 2: Radiation therapy for 6 weeks with docetaxel and cetuximab chemotherapy weekly
- Arm 3: Radiation therapy for 6 weeks with cisplatin chemotherapy weekly and atezolizumab immunotherapy every 3 weeks
Recurrent/Second Cancer Radiation Therapy
RTOG 3507 KEYSTROKE: A Randomized Phase II Study of Pembrolizumab Plus Stereotactic Re-irradiation versus SBRT Alone for Locoregionally Recurrent or Second Primary Head and Neck Carcinoma
Background: Outcomes need significant improvement in patients who develop another cancer in the same location as previous radiotherapy, whether it is a recurrence from the original malignancy or an entirely new cancer. Immunotherapy is a new treatment that directs the body to fight the cancer with the immune system, and it has been shown to improve survival in patients with metastatic disease. However, we do not know whether this treatment will improve survival in patients with non-metastatic cancer who have previously received radiotherapy.
Purpose: To assess the role of immunotherapy in combination with stereotactic body radiation therapy (SBRT) in patients with recurrent or second primary head and neck cancers.
Eligibility: Patients with pathologically confirmed recurrent or new primary head and neck cancer that is not amenable to curative resection with a history of prior radiation therapy to the head and neck and disease limited to a single site or adjacent sites.
Treatment: Randomized to Arm 1 or 2
- Arm 1: Re-irradiation SBRT in 5 treatments over 2 weeks
- Arm 2: Re-irradiation SBRT in 5 treatments over 2 weeks with pembrolizumab immunotherapy every 3 weeks for up to 2 years