Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intensity-Modulated or Proton Radiation Therapy for Sinonasal Malignancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01586767
Recruitment Status : Recruiting
First Posted : April 27, 2012
Last Update Posted : June 4, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Annie W. Chan, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE October 21, 2011
First Posted Date  ICMJE April 27, 2012
Last Update Posted Date June 4, 2021
Study Start Date  ICMJE July 2011
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2012)
Local Control Rates [ Time Frame: 2 years ]
To determine the local control rates with IMRT or proton radiation therapy at 2 years.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2012)
  • Vision preservation [ Time Frame: 5 years ]
    To determine the late visual-orbital late effects of IMRT or proton beam
  • Regional control [ Time Frame: 2 years ]
    To determine the regional control at 2 years after IMRT or proton
  • Survival [ Time Frame: 5 years ]
    To determine the long-term survival at 5 years after IMRT or proton
  • QOL [ Time Frame: 5 years ]
    To assess quality-of-life (QOL) outcomes after IMRT or proton
  • Patterns of Tumor Relapse [ Time Frame: 5 years ]
    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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intensity-Modulated or Proton Radiation Therapy for Sinonasal Malignancy
Official Title  ICMJE A Phase II Study of Intensity-Modulated or Proton Radiation Therapy for Locally Advanced Sinonasal Malignancy
Brief Summary

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

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Adenoid Cystic Carcinoma
  • Squamous Cell Carcinoma
  • Sinonasal Carcinoma
  • Sinonasal Undifferentiated Carcinoma
  • Mucoepidermoid Carcinoma
  • Schneiderian Carcinoma
  • Myoepithelial Carcinoma
  • Esthesioneuroblastoma
  • Melanoma
Intervention  ICMJE
  • Radiation: Proton radiation therapy
    Daily proton radiation therapy
  • Radiation: Intensity-modulated radiotherapy
    Daily intensity-modulated radiotherapy
    Other Name: IMRT
Study Arms  ICMJE
  • Active Comparator: Proton beam therapy
    Subjects treated at Massachusetts General Hospital with proton beam therapy
    Intervention: Radiation: Proton radiation therapy
  • Active Comparator: IMRT
    Intensity-modulated radiation therapy at institutions other than Massachusetts General Hospital
    Intervention: Radiation: Intensity-modulated radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 25, 2012)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2024
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Annie W Chan, MD 617-724-1159 awchan@partners.org
Contact: Elizabeth Weyman, BA 617-643-3505 eweyman@partners.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01586767
Other Study ID Numbers  ICMJE 10-308
2P01CA021239-29 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Annie W. Chan, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Annie W Chan, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP