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A Study to Determine the Treatment Outcomes and Toxicity of Intensity-Modulated or Proton Radiation Therapy for Sinonasal Malignancy

Overview

About this study

The purpose of this study is to determine if intensity-modulated radiotherapy (IMRT) or proton radiation therapy would result in improved local control rates and lowered toxicity compared to conventional radiotherapy. Data from retrospective studies suggest that IMRT and proton radiation therapy each resulted in promising outcomes for patients with sinonasal malignancy. No previous prospective study has been conducted to evaluate the outcome of sinonasal cancer treated with IMRT or proton radiation therapy.

The study would also assess if proton radiation therapy would result in equivalent or improved local control rate with similar or lower toxicity compared to IMRT.  It is not known if one is superior to the other in terms of local control and toxicity outcome. It is also not clear if a subset of patients would benefit more from one treatment technology versus the other.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Biopsy proven, within 16 weeks prior to study entry, sinonasal adenoid cystic carcinoma, adenocarcinoma, mucoepidermoid carcinoma, squamous cell carcinoma, including sinonasal carcinoma, sinonasal undifferentiated carcinoma, Schneiderian carcinoma, myoepithelial carcinoma, undifferentiated carcinoma, esthesioneuroblastoma, or melanoma AJCC 7th edition Stage III - IVA/B tumors, or with skull base or intracranial extension
  • Pathology must be confirmed by review at the treating institution
  • Biopsy proven locally advanced sinus, nasal cavity, hard palate, soft palate, major or minor salivary gland tumors, or lacrimal apparatus, with nasal cavity, sinus, auditory canal, or skull base involvement
  • Eastern cooperative oncology group (ECOG) performance status 0 - 1 or Karnofsky Performance Status ≥ 70. (Appendix B)
  • Must undergo pre-treatment evaluation of tumor extent prior to study entry through imaging studies and clinical examinations, including
    • CT and/or MRI of skull base, brain and neck within 28 days prior to study entry
    • Physical examination +/- nasal endoscopy within 28 days prior to study entry
    • CT of the chest within 60 days prior to study entry
  • Nutritional and general physical condition must be considered compatible with the proposed radiation with or without chemotherapy treatment
  • Normal organ and marrow function

Exclusion Criteria:

  • Active alcohol addiction
  • Pregnant or breastfeeding
  • Receiving any other study agents
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin for subjects who will receive chemotherapy
  • Evidence of distant metastases or distant leptomeningeal metastases
  • Previous irradiation for head and neck tumor, skull base, or brain tumors
  • Uncontrolled intercurrent illness
  • History of a different malignancy unless disease-free for at least 2 years and deemed by the investigator to be at low-risk for recurrence
    • The following cancers are eligible if diagnosed and treated for cure within the past 2 years
      • Cervical cancer in situ
      • Carcinoma in situ of the breast
      • Basal cell or squamous cell carcinoma of the skin

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Robert Foote, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

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CLS-20307638

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