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.

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

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/

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

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

Exclusion Criteria

EXCLUSION: Metastases Previous HN treatment Other malignancy Infection Medical/psychiatric illness Certain chemotherapy

Research Questions Addressed Advanced therapy deliverance can spare

critical tissue Reduce radiation side effects

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

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

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

Localization, Simulation, Immobilization

Localization Treatment planning

CT scans MRI scans Include all areas of

interest Immobilization

Same for all scanning modalities

Treatment Planning Target Volumes ICRU Report #50

GTV CTV PTV

Primary target PTV 66

Secondary Target PTV 54

Lymph Nodes

Critical Structures

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

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

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

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

Thanks for listening!

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.