Clinical Trial - NCT01586767

Intensity-Modulated or Proton Radiation Therapy for Sinonasal Malignancy

Recruiting

Sponsor: Massachusetts General Hospital

Collaborators: National Institutes of Health (NIH), National Cancer Institute (NCI)

Information provided by (Responsible party): Principal Investigator Massachusetts General Hospital Annie W. Chan, MD Assistant Professor

ClinicalTrials.gov Identifier: NCT01586767

Protocol Info

Short Description: Phase II of Proton Beam Therapy For Locally Advanced Sinonasal Malignancies
Long Description: A Phase II Study Of Proton Beam Therapy For Locally Advanced Sinonasal Malignancies
MGH Status: Open
Sponsor: DF/HCC
Disease Program: Proton

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




Purpose

The purpose of this study is to test the hypothesis that 1)intensity-modulated radiotherapy (IMRT) or proton radiation therapy would result in improved local control rate and lowered toxicity compared to conventional radiotherapy, and 2) proton radiation therapy would result in equivalent or improved local control rate with similar or lower toxicity compared to IMRT, in the treatment of locally advanced sinonasal malignancy. Data from retrospective studies suggest that IMRT or proton radiation therapy resulted in promising outcome in patients with sinonasal malignancy. To this date, no prospective study has been conducted to evaluate the outcome of sinonasal cancer treated with IMRT or proton radiation therapy. This Phase II trial is the first prospective study conducted to determine the treatment outcome and toxicity of IMRT or proton in the treatment of sinonasal cancer. IMRT and proton radiation therapy are the two most established and most commonly employed advanced radiotherapy techniques for the treatment of sinonasal cancer. It is highly controversial whether 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. Due to the rarity and heterogeneity of sinonasal malignancies and the fact that proton beam is only available at a few centers in the United States, it is not feasible at present to do a Phase III study randomizing patients between IMRT and proton radiation therapy. In this study, a planned secondary analysis will be performed, comparing the treatment and toxicity outcome between IMRT and proton. The data on the IMRT and proton comparison from this trial will be used to design future multi-center prospective trials and to determine if randomized trial is necessary. In this study, the treatment technique employed for an individual case will not be determined by the treating physician(s), but rather by the most advanced technology available at the treating institution for the treatment of the sinonasal cancer. At the Massachusetts General Hospital (MGH), proton beam therapy will be used for patients who meet the eligibility criteria. For institutions where protons are not available or institutions where the proton planning systems have not been optimized, IMRT exclusively will be used for the treatment of sinonasal cancer. Patient and tumor characteristics are expected to be comparable between IMRT- and proton- institutions
Condition Title Intervention Phase
Adenoid Cystic Carcinoma Squamous Cell Carcinoma Sinonasal Carcinoma Sinonasal Undifferentiated Carcinoma Mucoepidermoid Carcinoma Schneiderian Carcinoma Myoepithelial Carcinoma Esthesioneuroblastoma Melanoma Proton radiation therapy Intensity-modulated radiotherapy N/A
Study Type Interventional
Official Title A Phase II Study of Intensity-Modulated or Proton Radiation Therapy for Locally Advanced Sinonasal Malignancy

Primary Outcome Measures

Local Control Rates [Time Frame: 2 years] [Designated as safety issue: ]


Secondary Outcome Measures

Vision preservation [Time Frame: 5 years] [Designated as safety issue: ]

Regional control [Time Frame: 2 years] [Designated as safety issue: ]

Survival [Time Frame: 5 years] [Designated as safety issue: ]

QOL [Time Frame: 5 years] [Designated as safety issue: ]

Patterns of Tumor Relapse [Time Frame: 5 years] [Designated as safety issue: ]

Local control [Time Frame: 5 years] [Designated as safety issue: ]

Neurocognitive function [Time Frame: 5 years] [Designated as safety issue: ]

Estimated Enrollment: 90
Study Start Date: July 2011
Estimated Study Completion Date: July 2024
Estimated Primary Completion Date: July 2021
Arms Assigned Interventions

Active Comparator:Proton beam therapy

Subjects treated at Massachusetts General Hospital with proton beam therapy
Radiation:Proton radiation therapy
Daily proton radiation therapy

Active Comparator:IMRT

Intensity-modulated radiation therapy at institutions other than Massachusetts General Hospital
Radiation:Intensity-modulated radiotherapy
Daily intensity-modulated radiotherapy

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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.
  • Patients with 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 are eligible.
  • Eastern cooperative oncology group (ECOG) performance status 0 - 1 or Karnofsky Performance Status = 70. (Appendix B)
  • All patients 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; and CT of the chest within 60 days prior to study entry.
  • Nutritional and general physical condition must be considered compatible with the proposed radiation +/- 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 are deemed by the investigator to be at low-risk for recurrence. Individuals with 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, and basal cell or squamous ceel carcinoma of the skin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01586767

Locations

  • United States, Massachusetts
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02114
  • United States, Minnesota
    • Mayo Clinic Rochester Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Massachusetts General Hospital

National Institutes of Health (NIH)

National Cancer Institute (NCI)

More Information

No publications provided

Responsible Party: Principal Investigator Massachusetts General Hospital Annie W. Chan, MD Assistant Professor
ClinicalTrials.gov Identifier: NCT01586767
Other Study ID Numbers: 2P01CA021239-29
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Massachusetts General Hospital:

Nasal cavity

Salivary gland tumors

Hard palate

Sinus

Soft Palate

Lacrimal Apparatus

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Adenoid Cystic

Carcinoma, Mucoepidermoid

Esthesioneuroblastoma, Olfactory

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on April 09, 2020