IMRT vs Proton Radiation Therapy for Sinonasal Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Intensity-modulated radiotherapy (IMRT) and Proton radiation therapy for sinonasal cancer?
Research comparing different radiation therapies for sinonasal cancer shows that both proton radiation therapy (PRT) and intensity-modulated radiation therapy (IMRT) have similar effectiveness in terms of overall survival and local control. However, carbon ion radiation therapy (CIRT) showed better outcomes than both PRT and IMRT, suggesting that while PRT and IMRT are effective, there may be more effective options available.12345
Is IMRT or Proton Radiation Therapy safe for treating sinonasal cancer?
How does IMRT differ from other treatments for sinonasal cancer?
IMRT (Intensity-modulated radiation therapy) and proton radiation therapy are advanced forms of radiation treatment that precisely target tumors, minimizing damage to surrounding healthy tissues. Unlike conventional radiation, these therapies can better spare non-adjacent organs and reduce the risk of secondary cancers, making them unique options for treating sinonasal cancer.14589
What is the purpose of this trial?
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
Research Team
Annie W. Chan
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
This trial is for patients with advanced sinonasal cancers, including various carcinoma types and melanoma. Participants must have a good performance status, meaning they can carry out daily activities with little or no assistance. They should also have normal organ function and no history of allergic reactions to similar chemotherapy drugs if receiving chemotherapy.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daily proton or IMRT radiation therapy, with optional concurrent standard chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Intensity-modulated radiotherapy
- Proton radiation therapy
Intensity-modulated radiotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Head and neck cancers
- Brain tumors
- Prostate cancer
- Head and neck cancers
- Brain tumors
- Prostate cancer
- Breast cancer
- Head and neck cancers
- Brain tumors
- Prostate cancer
- Head and neck cancers
- Brain tumors
- Prostate cancer
- Head and neck cancers
- Brain tumors
- Prostate cancer
- Head and neck cancers
- Brain tumors
- Prostate cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
National Cancer Institute (NCI)
Collaborator