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Phase I/II Study of Conformal and Intensity Modulated Irradiation for Oropharyngeal Cancer

Principal Investigator:  Avraham Eisbruch, M.D. RTOG-o022. Phase I/II Study of Conformal and Intensity Modulated Irradiation for Oropharyngeal Cancer. Heather Schultz Dos 741 October 2012. Clinical Trial. Current Version Date: 7/7/2004 Target Accrual:  64 Current Accrual:  69

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Phase I/II Study of Conformal and Intensity Modulated Irradiation for Oropharyngeal Cancer

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  1. Principal Investigator: Avraham Eisbruch, M.D. RTOG-o022 Phase I/II Study of Conformal and Intensity Modulated Irradiation for Oropharyngeal Cancer Heather Schultz Dos 741 October 2012

  2. Clinical Trial • Current Version Date: 7/7/2004 • Target Accrual: 64 • Current Accrual: 69 • **Closed to accrual • Stage I/II randomized clinical trial • Looking at safety and how well the treatment works

  3. Trial Objectives • Coverage vs. Sparing • Locoregional tumor recurrence • Acute and late side effects http://ncip.nci.nih.gov/blog/2012/08/03/radiation-therapy-oncology-group-rtog-bioinformatics/

  4. Background • The standard radiation for advanced oropharyngeal tumors typically involves administering a high radiation dose to the major salivary glands bilaterally. • Xerostomia • Use of conformal and IMRT techniques to spare tissues and irradiate targets • Important issues • Target outlining • Target miss • Accelerated fractionation

  5. Inclusion Criteria • INCLUSION: • Biopsy-proven stage I-III • Surgery limited • Performance status • Pre-Tx evaluation • General health • Mentally reliable • No other HN treatment • Signed informed consent

  6. Exclusion Criteria • EXCLUSION: • Metastases • Previous HN treatment • Other malignancy • Infection • Medical/psychiatric illness • Certain chemotherapy

  7. Research Questions Addressed • Advanced therapy deliverance can spare critical tissue • Reduce radiation side effects

  8. Study Controls/Arms • Treatment arms • RTOG 0022 for those qualified for oropharyngeal radiation therapy treatment • Evaluating outcomes • Advanced radiation therapy techniques vs • Standard radiation therapy techniques

  9. Radiation Therapy Treatment Planning • Planning Goals: Salivary Glands • Parotid glands: • Mean dose to either parotid < 26 Gy or • At least 50% of the either parotid gland will receive < 30 Gy or • At least 20 cc of the combined volume of both parotid glands will receive < 20Gy. • Submandibular/sublingual glands and oral cavity: • Planning Priorities • Critical normal structure constraints followed by the prescription goals are the most important planning priorities. • The priorities in addressing the protocol aims and constraints will be in the following order: • Critical Normal Structure Constraints

  10. Dose Specifications • The prescription dose is the isodose which encompasses at least 95% of the planning target volume (PTV). • Prescription dose to the PTVs shall be according to the following • The reported doses for each PTV shall include the prescription dose • The method used for tissue heterogeneity calculations shall be reported

  11. Localization, Simulation, Immobilization • Localization • Treatment planning CT scans • MRI scans • Include all areas of interest • Immobilization • Same for all scanning modalities

  12. Treatment Planning Target Volumes • ICRU Report #50 • GTV • CTV • PTV • Primary target • PTV 66 • Secondary Target • PTV 54 • Lymph Nodes

  13. Critical Structures

  14. Risks of Patient Involvement • Very Likely Risks • Redness/irritation • Dysphagia • Xerostomia • Ulceration • Hair loss • Nausea • Change in appetite • Decrease in blood counts/fatigue • Less Likely Risks • Hoarseness • Osteoradionecrosis • Thyroid issues • Irradiation of the spinal cord **small risk that your chance of cure may be lower

  15. Benefits of Patient Participation • Patients receiving treatment • Clinics incorporating effective treatment regiments developed from this clinical trial • People/Organizations conducting research similar to this clinical trial

  16. Benefits of Clinical Trials • Determining effectiveness of interventions • Treatment dependant outcome variances • Influential to clinical practice • Part of research process • Knowledge of progress against cancer

  17. Involved Organizations • Food and Drug Administration (FDA) • National Cancer Institute (NCI) • Radiation Therapy Oncology Group (RTOG) • American College of Radiology (ACR) https://www.chartrounds.com/clinical_trials.aspx

  18. Thanks for listening!

  19. References 1. Lenards, Nishele. “Clinical trials.” PowerPoint presentation. D2L UWLax Protocols & Studies. Accessed: October 19, 2012. RTOG Website. Phase I/II Study of Conformal and Intensity Modulated Irradiation for Oropharyngeal Cancer. http://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?study=0022. Accessed October 17, 2012. Radiation Therapy Oncology Group. Clinical Trials Exploring New Directions in Radiation Therapy, Quality of Life Research, Radiation Therapy Oncology Group Translational Research Philadelphia PA; October 2010. Ploquin N, Lau H, Dunscombe P. Intensity modulated and three-dimensional conformal radiation therapy plans for oropharyngeal cancer: a comparison of their sensitivity to set-up errors and uncertainties. Curr Oncol. 2006 Apr;13(2):61-6.

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