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1. A Study to Determine the Best Individualized Cancer Therapy Using Circulating Tumor DNA (ctDNA) in Patients with GI, CNS, and Thoracic Cancers.

   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.

2. A Study to Evaluate Contouring Organs at Risk for Treatment Planning

   Scottsdale/Phoenix, Ariz., Jacksonville, Fla., Rochester, Minn.

   The purpose of this study is to determine:  if the artificial intelligence (AI)-generated results are less arduous than manual tracing by radiation oncologist, and the non-inferiority of the quality of AI vs. manual tracing.  These aims will be evaluated in a clinical environment to investigate the impact of an AI algorithm on the clinical workflow. 

   Radiotherapy treatment planning requires precise calculations of radiation exposure, not only for the target volumes (tissue containing malignancy), but of nearby organs-at-risk (OARs), in which the exposure needs to be minimized. Manual segmentation of these organs is a time-consuming task with high interobserver variability. Producing these segmentations automatically will reduce the time required for treatment planning and improve the interobserver variability.

3. Reduced Craniospinal Radiation Therapy and Chemotherapy in Treating Younger Patients With Newly Diagnosed WNT-Driven Medulloblastoma

   Rochester, Minn.

   This phase II trial studies how well reduced doses of radiation therapy to the brain and spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of brain tumor called WNT)/Wingless (WNT)-driven medulloblastoma. Recent studies using chemotherapy and radiation therapy have been shown to be effective in treating patients with WNT-driven medulloblastoma. However, there is a concern about the late side effects of treatment, such as learning difficulties, lower amounts of hormones, or other problems in performing daily activities. Radiotherapy uses high-energy radiation from x-rays to kill cancer cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, vincristine sulfate, cyclophosphamide and lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving reduced craniospinal radiation therapy and chemotherapy may kill tumor cells and may also reduce the late side effects of treatment.

4. Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients with Locally Advanced Rectal Cancer Undergoing Surgery

   Scottsdale/Phoenix, Ariz., Rochester, Minn.

   The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation therapy) prior to surgery. Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of the cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation and there have been important advances in chemotherapy, surgery, and radiation which may be of benefit. The purpose of this study is to compare the effects, both good and bad, of the standard treatment of chemotherapy and radiation to chemotherapy using a combination regimen known as FOLFOX, (the drugs 5-fluorouracil (5-FU), oxaliplatin and leucovorin) and selective use of the standard treatment, depending on response to the FOLFOX. The drugs in the FOLFOX regimen are all FDA (Food and Drug Administration) approved and have been used routinely to treat patients with advanced colorectal cancer.

5. 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

   Rochester, Minn.

   This randomized phase II/III trial studies how well radiation therapy works when given together with cisplatin compared to docetaxel or cetuximab and docetaxel after surgery in treating patients with stage III-IV squamous cell head and neck 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 cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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 transmit tumor killing molecules to them. It is not yet known whether radiation therapy is more effective when given with cisplatin, docetaxel, or cetuximab and docetaxel.

6. A Study to Evaluate Fractionated Radiation Therapy Utilizing GRID Therapy for Locally-advanced Bulky Tumors

   Rochester, Minn., Jacksonville, Fla.

   The purpose of this research is to study radiographic control at the 3 month time-point, the side effects (good & bad), survival outcomes and proof of this idea in patients who have had grid therapy for locally advanced bulky tumors of the heat and neck, thorax, abdomen and extremities.

7. A Study of Proton Radiation Divided into Fewer Doses for Low Risk Prostate Cancer

   Rochester, Minn., Scottsdale/Phoenix, Ariz.

   The purpose of this study is to compare the effects (good and bad) on patients with prostate cancer by comparing the standard dose of radiation therapy (44 treatments over 8½-9 weeks) with a higher daily dose of radiation (5 treatments over 1-2 weeks) to see if the effects of the treatments are similar or better.

8. A Consortium Trial to Evaluate Proton vs. Photon Therapy for Patients with Non-metastatic Breast Cancer

   Jacksonville, Fla.

   The purpose of this study to assess the effectiveness of proton vs. photon therapy in reducing major cardiovascular events (MCE), defined as atherosclerotic coronary heart disease or other heart disease death, myocardial infarction, coronary revascularization, or hospitalization for major cardiovascular event (heart failure, valvular disease, arrhythmia, or unstable angina or other major cardiovascular event) in patients with locally-advanced breast cancer.

    

9. Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy with Adjuvant PCV Chemotherapy in Patients with Anaplastic Glioma or Low Grade Glioma

   Jacksonville, Fla., Rochester, Minn.

   The purpose of this study is to evaluate whether radiation therapy with adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma.

    

    

10. A Study to Evaluate Circulating Tumor DNA (ctDNA) and Immunophenotyping as Potential Biomarkers in Patients Undergoing Regional Nodal Irradiation for Breast Cancer

    Rochester, Minn.

    The purpose of this study is to estimate the circulating tumor DNA (ctDNA)detection rate and mutational load in breast cancer patients with indications for regional nodal irradiation.