Intensity-Modulated or Proton Radiation Therapy for Sinonasal Malignancy

This study is currently recruiting participants.
Verified January 2014 by Massachusetts General Hospital
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Annie W. Chan, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01586767
First received: October 21, 2011
Last updated: January 28, 2014
Last verified: January 2014
  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 Intervention Phase
Adenoid Cystic Carcinoma
Squamous Cell Carcinoma
Sinonasal Carcinoma
Sinonasal Undifferentiated Carcinoma
Radiation: Proton radiation therapy
Radiation: Intensity-modulated radiotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Intensity-Modulated or Proton Radiation Therapy for Locally Advanced Sinonasal Malignancy

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Local Control Rates [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To determine the local control rates with IMRT or proton radiation therapy at 2 years.


Secondary Outcome Measures:
  • Vision preservation [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    To determine the late visual-orbital late effects of IMRT or proton beam

  • Regional control [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To determine the regional control at 2 years after IMRT or proton

  • Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To determine the long-term survival at 5 years after IMRT or proton

  • QOL [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To assess quality-of-life (QOL) outcomes after IMRT or proton

  • Patterns of Tumor Relapse [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To determine the patterns of tumor relapse after IMRT or proton

  • Local control [ Time Frame: 5 years ]
    To determine long-term local control after IMRT or proton

  • Neurocognitive function [ Time Frame: 5 years ]
    To determine long-term neurocognitive function after IMRT or proton


Estimated Enrollment: 90
Study Start Date: July 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
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
Other Name: IMRT

Detailed Description:

Subjects will receive daily proton radiation treatment as outpatients at the Francis H. Burr Proton Center at Massachusetts General Hospital. The subjects may also receive concurrent standard chemotherapy every week during their radiation therapy. This chemotherapy is considered standard treatment for their cancer and is not being done for research purposes.

In addition to daily radiation treatments, subjects will have the following tests every week: review of side effects; physical exam, including weight, height, neurological exam and vital signs; and blood tests, only for those subjects also receiving chemotherapy.

Subjects will be followed for 5 years after the completion of study treatment. The first follow-up visit will be 6-8 weeks after completion of study treatment. Additional follow-up visits will be performed every 3 months during the first 2 years following completion of radiation then every 6 month during years 3-5. At each follow-up visit, subjects will receive a physical exam, chest CT scan (at 1st follow-up visit then at least every 6 months), a CT or MRI tumor assessment (at 1st follow-up visit then at least every 6 months), quality-of-life questionnaire, hearing test, neuro-ophthalmology test, and neurocognitive test.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy proven of sinonasal adenoid cystic carcinoma or squamous cell carcinoma within 12 weeks 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

Contacts
Contact: Annie W Chan, MD 617-726-7559 awchan@partners.org
Contact: Barbara Winrich, MS 617-724-2334 bwinrich@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Annie W Chan, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Annie W Chan, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Annie W. Chan, MD, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01586767     History of Changes
Other Study ID Numbers: 10-308, 2P01CA021239-29
Study First Received: October 21, 2011
Last Updated: January 28, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Massachusetts General Hospital:
Nasal cavity
Salivary gland tumors
Hard palate

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Adenoid Cystic
Maxillary Sinus Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Adenocarcinoma
Paranasal Sinus Neoplasms
Nose Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nose Diseases
Respiratory Tract Diseases
Paranasal Sinus Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on April 21, 2014