OPSCC N0 Nodal Control With Reduced IMRT

Paul W. Read, MD

Status: Terminated

Conditions: Oropharyngeal Squamous Cell Carcinoma (OPSCCA); HPV (Human Papillomavirus)-Associated

Treatments: Radiation: 39.6 Gy radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT01891695

16766

Details and patient eligibility

About

The dose of radiation most commonly used to treat oropharyngeal cancer results in side effects including sores in the mouth and throat, dry mouth and thick saliva, loss or altered taste, swallowing problems including pain or inability to swallow requiring feeding tubes to be placed in the stomach, hoarseness or breathing problems from swelling requiring tracheostomy or a hole surgically placed in the windpipe to allow the patient to breathe, nausea and vomiting, fatigue and loss of energy, decreased hearing from fluid behind the ear drums in the middle ear, skin redness tenderness and blistering.

The purpose of this study is to determine if the investigators can reduce the dose of radiation to the lymph nodes in the neck that may contain cancer cells that are not detected by physical examinations or radiologic studies (CT scans, PET CT scans, or MRI scans) in order to reduce the side effects from treatment and still adequately kill any cancer cells that may be contained in those lymph nodes.

Full description

A Pilot Single Arm Study of Intensity Modulated Radiation Therapy Elective Nodal Dose De-Escalation for HPV-Associated Squamous Cell Carcinoma of the Oropharynx.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patient must be clinically referred for radiation for stage I-IVb OPSCCA
• tumor must be HPV-associated p16+
• patient must be able to lie flat and tolerate immobilization systems

Exclusion criteria

• patients may not be receiving any investigational agents
• prior radiation to head and neck
• any other malignancy except non-melanomatous skin cancer or a carcinoma not of head and neck origin with patient being disease free for at least 5 years
• any major medical, psychiatric, or neurologic illness
• pregnant or breastfeeding women

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Reduced Intensity Radiation

Experimental group

Description:

39.6 Gy radiation to clinically uninvolved cervical lymphatics

Treatment:

Radiation: 39.6 Gy radiation