Daniel J. Ma, M.D.

Closed for Enrollment

• A Phase III Study of Postoperative Radiation Therapy (IMRT) /- Cetuximab for Locally-Advanced Resected Head and Neck Cancer Rochester, Minn., Mankato, Minn., La Crosse, Wis., Jacksonville, Fla., Albert Lea, Minn.

  RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses over a shorter period of time, may kill more tumor cells and have fewer side effects. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether radiation therapy is more effective when given alone or together with cetuximab in treating patients with head and neck cancer that has been removed by surgery.

  PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with cetuximab in treating patients who have undergone surgery for locally advanced head and neck cancer.

• A Randomized Evaluation of Machine Learning Assisted Radiation Treatment Planning versus Standard Radiation Treatment Planning (GMROR2371) La Crosse, Wis., Mankato, Minn., Rochester, Minn., Scottsdale/Phoenix, Ariz., Eau Claire, Wis., Jacksonville, Fla., Albert Lea, Minn.

  The purpose of this study is to determine the magnitude of clinical benefit achieved through machine learning assisted radiation treatment planning (MLAP) on post-treatment clinical outcomes such as acute toxicity and patient reported outcomes.

• A Randomized Phase II Study of Concurrent Intensity Modulated Radiation Therapy (IMRT), Paclitaxel and Pazopanib (NSC 737754)/Placebo, for the Treatment of Anaplastic Thyroid Cancer Rochester, Minn., Jacksonville, Fla.

  This randomized phase II trial is studying the side effects and how well giving intensity-modulated radiation therapy (IMRT) and paclitaxel together with or without pazopanib hydrochloride works in treating patients with anaplastic thyroid cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving radiation therapy and paclitaxel together is more effective with pazopanib hydrochloride in treating thyroid cancer.

• A Randomized Phase II/Phase III Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors Rochester, Minn.

  RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given together with chemotherapy or alone after surgery in treating salivary gland tumors. PURPOSE: This randomized phase II/III trial is studying radiation therapy with or without chemotherapy to see how well it works in treating patients with high-risk malignant salivary gland tumors that have been removed by surgery.

• A Study of Mucosal Sparing Proton Beam Therapy (PBT) in Resected Oropharyngeal Tumors Rochester, Minn., Scottsdale/Phoenix, Ariz.

  The purpose of this study is to evaluate the clinical outcomes of lower intensity (mucosal tissue sparing) proton beam therapy after the surgical removal of oropharyngeal tumors in cancer patients who have a favorable level of risk.

• DART-HPV: A Phase III Evaluation of De-escalated Adjuvant Radiation Therapy for HPV-Associated Oropharynx Cancer Rochester, Minn., La Crosse, Wis., Eau Claire, Wis., Scottsdale/Phoenix, Ariz.

  This study is designed for patients with a cancer of the oropharynx (tonsils or base of tongue) caused by the HPV virus. Traditional treatment involves surgery followed by six weeks of daily radiation therapy. This study investigates a less intense radiation treatment following surgery that uses half the dose of radiation given over two weeks rather than six weeks. Patients will be randomly assigned to receive the less intense treatment versus the traditional treatment by coin flip. Patients are twice as likely to receive the less intense treatment during randomization.

• MC1974: A Study of Mucosal Sparing Adjuvant Radiotherapy After Surgical Exploration In HPV Head And Neck Cancer Of Unknown Primaries (HNCUP) Rochester, Minn., Scottsdale/Phoenix, Ariz.

  The purpose of this study is to evaluate the clinical outcomes of de-intensified (mucosal sparing, possible ipsilateral neck) radiotherapy after surgical exploration of favorable risk HNCUP patients. evaluates the clinical outcomes of de-intensified (mucosal sparing, possible ipsilateral neck) radiotherapy after surgical exploration of favorable risk HNCUP patients.

• Phase II Evaluation of Adjuvant Hyperfractionated Radiation and Docetaxel for HPV Associated Oropharynx Cancer Rochester, Minn., Scottsdale/Phoenix, Ariz.

  This phase II trial studies how well radiation therapy and docetaxel work in treating patients with human papillomavirus (HPV)-related oropharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy with docetaxel my kill more tumor cells.

• Phase II/III Randomized Trial of Intensity-Modulated Proton Beam Therapy (IMPT) versus Intensity-Modulated Photon Therapy (IMRT) for the treatment of Oropharyngeal Cancer of the Head and Neck Rochester, Minn., Scottsdale/Phoenix, Ariz.

  The overall goal of this trial is to identify a less toxic approach to the delivery of conformal radiation therapy for patients with cancers of the oropharynx.

• Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-Associated OPSCC (ROR2073) Rochester, Minn.

  The primary purpose of this study is to assess novel tumor genomic biomarkers (TRAF3 and CYLD gene defects and HPV integration) of recurrence risk in patients with Human papillomavirus+oropharyngeal squamous cell carcinoma (HPV+OPSCC) undergoing curative-intent therapy. 

• ROR1771: A Prospective Observational Study of Proton Stereotactic Body Radiation Therapy and Immunotherapy for Recurrent/Progressive Locoregional or Metastatic Head and Neck Cancer Rochester, Minn., Scottsdale/Phoenix, Ariz.

  This study observes the clinical efficacy of combining proton SBRT with PD-1 blockade immunotherapy in both the locoregionally recurrent and metastatic settings.