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Protocol No.20110GCCPrincipal InvestigatorWitek, Matthew
PhasePhase I/II
Age GroupAdult
TitleA single-arm, single-stage phase II trial of Selective Avoidance of nodal VolumEs at minimal Risk (SAVER) in the contralateral neck of patients with p16-positive oropharynx cancer
Key EligibilityInclusion Criteria

Is there pathologically (histologically or cytologically) proven diagnosis of p16+ squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil or base of tongue)?

Does the patient require elective contralateral radiotherapy in the definitive or adjuvant setting (i.e. base of tongue primary or tonsil with base of tongue invasion, soft palate invasion, or medialized as defined by > 1/3 of the distance from the tonsil to the midline of the soft palate?

Does the patient have clinical stage T1-4, N0, N1 or N3, and M0 disease?

Was a general history and physical examination performed within 60 days prior to registration?

Was the patient Zubrod Performance Status 0-1 within 30 days prior to registration?

Is the patient age greater than or equal to 18 years?

For women of childbearing potential, was a serum pregnancy test completed within 2 weeks of initiation or radiotherapy?

If yes, was the serum pregnancy test negative?

If a woman of child-bearing potential or sexually active male, is the patient willing to use effective contraception throughout their participation in the treatment phase of the study and at least 180 days following the last study treatment.

Did the patient provide study specific informed consent prior to study entry, including consent for mandatory submission of tissue for required p16 review?

**For more information, Please call study site contact.




Applicable Disease SitesEsophagus
H&N
Laryngeal
Larynx
Lip, Oral Cavity and Pharynx
StatusOpen
Treatment TypeTreatment
ClinicalTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT04609280
ContactKelly Kitzmiller Phone:
Pager:
Email:kelly.kitzmiller@umm.edu
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