Randomized Trial of Intensity-Modulated Proton Beam Therapy (IMPT) Versus Intensity-Modulated Photon Therapy (IMRT) for the Treatment of Oropharyngeal Cancer of the Head and Neck

Overview

Información sobre este estudio

The overall goal of this trial is to identify a less toxic approach to the delivery of conformal radiation therapy for patients with cancers of the oropharynx.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Age ≥ 18 years old.
  • ***Histologically documented Squamous Cell Carcinoma of the oropharynx (AJCC v7** Stage III-IV A,B).
  • *Tumor tissue (primary or cervical metastasis) available for human papilloma virus (HPV) and/or p16 (in situ hybridization (ISH), immunohistochemistry (IHC) or genotyping testing).
  • If you do not have enough leftover tumor tissue available, you will have a tumor biopsy for tumor marker testing.
  • Eastern Cooperative Oncology Group (ECOG) performance status= 0, 1, or 2.
  • Negative pregnancy test for women of child bearing potential.
  • Concurrent chemotherapy.
  • Bilateral neck radiation.

Exclusion Criteria:

  • Previous radiation treatment for head and neck mucosal primary cancers within the past 5 years (i.e., oropharynx, nasopharynx, hypopharynx, larynx, and oral cavity).
  • Pregnant or breast-feeding females.
  • Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to:
    • Symptomatic congestive heart failure, unstable angina, or cardiac dysrrhythmia not controlled by pacer device;
    • No myocardial infarction within 3 months of registration.
  • Distant metastases (AJCC v7** Stage IV C, any T, any N and M1).
  • Previous surgical resection or neck dissection for oropharyngeal cancer, administered with therapeutic intent.

*    If you do not have enough leftover tumor tissue available, you will have a tumor biopsy for tumor marker testing.
**  American Joint Committee on Cancer (AJCC) 7th edition.
*** For clinically visible or radiographically diagnosed oropharynx cancer, neck mass biospy/US FNA is acceptable.

 

 

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Daniel Ma, M.D.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Samir Patel, M.D.

Cerrado para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publicaciones

Publications are currently not available
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CLS-20267893

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