Byron C. May, M.D.

Closed for Enrollment

• A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Superoxide Dismutase Mimetic GC4419 to Reduce Severe Oral Mucositis (SOM) Associated With Chemoradiotherapy for Locally Advanced, Non-Metastatic Head and Neck Cancer Jacksonville, Fla.

  The purpose of this study is to determine if GC4419, administered prior to intensity-modulated radiation therapy (IMRT), reduces the severity of radiation-induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck.

• 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 Phase II-R and a Phase III Trial Evaluating Both *Erlotinib (PH II-R) and Chemoradiation (PH III) as Adjuvant Treatment For Patients with Resected Head of Pancreas Adenocarcinoma Rochester, Minn., Jacksonville, Fla.

  This randomized phase II-R/III trial studies gemcitabine hydrochloride with or without erlotinib hydrochloride followed by the same chemotherapy regimen with or without radiation therapy and capecitabine or fluorouracil in treating patients with pancreatic cancer that was removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, capecitabine, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. Giving chemotherapy together with or without erlotinib hydrochloride and/or radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective when given with or without erlotinib hydrochloride and/or radiation therapy in treating pancreatic cancer.

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

• Biologically Adaptive Therapy (BAT) for Locally Advanced GI, CNS and Thoracic Malignancies at Mayo Clinic Florida: Personalizing Cancer Therapy Through Genomic Assessment of Blood-derived Circulating Tumor DNA (ctDNA). Jacksonville, Fla.

  This study proposes to develop and maintain a biorepository of blood samples collected from patients receiving definitive chemoradiotherapy for locally advanced rectal cancer, locally advanced pancreatic cancer, non-small cell lung cancer, or cervical cancer. The ultimate goal of this biorepository will be to provide the resource to initiate an exploration of ctDNA as a potential liquid biopsy for GI and Thoracic malignancy detection and surveillance.

• PACER (Pancreatic AdenoCarcinoma with Electron intraoperative Radiation therapy): An exploratory study of electron beam intraoperative radiation therapy following chemoradiation in patients with pancreatic cancer with vascular involvement Rochester, Minn., Jacksonville, Fla.

  The purpose of this study is to to evaluate the rate of overall survival (OS) at two years in patients with either borderline or locally advanced pancreatic cancer who receive electron beam intraoperative radiation therapy (IORT) following chemotherapy and radiation therapy.

• ROR2272: Evaluation of a Novel Auto Segmentation Algorithm for Normal Structure Delineation in Radiation Treatment Planning (ROR2272) Mankato, Minn., Rochester, Minn., La Crosse, Wis., Jacksonville, Fla., Eau Claire, Wis., Albert Lea, Minn., Scottsdale/Phoenix, Ariz.

  The purpose of this study is to integrate a novel head and neck segmentation algorithm into the current clinical standard operating procedure for radiation treatment planning within the Mayo Clinic Department of Radiation Oncology Practice.