Phase I/II Study of Conformal and Intensity Modulated Irradiation for Oropharyngeal Cancer
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Phase I/II Study of Conformal and Intensity Modulated Irradiation for Oropharyngeal Cancer
RTOG-o022
Heather Schultz Dos 741
October 2012
Principal Investigator: Avraham Eisbruch, M.D.
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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
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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/
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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
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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
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Exclusion Criteria
EXCLUSION: Metastases Previous HN treatment Other malignancy Infection Medical/psychiatric illness Certain chemotherapy
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Research Questions Addressed Advanced therapy deliverance can spare
critical tissue Reduce radiation side effects
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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
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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
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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
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Localization, Simulation, Immobilization
Localization Treatment planning
CT scans MRI scans Include all areas of
interest Immobilization
Same for all scanning modalities
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Treatment Planning Target Volumes ICRU Report #50
GTV CTV PTV
Primary target PTV 66
Secondary Target PTV 54
Lymph Nodes
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Critical Structures
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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
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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
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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
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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
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Thanks for listening!
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References
1. Lenards, Nishele. “Clinical trials.” PowerPoint presentation. D2L UWLax Protocols & Studies. Accessed: October 19, 2012.
2. 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.
3. 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.
4. 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.