IMRT vs Proton Radiation Therapy for Sinonasal Cancer

Recruiting at 1 trial location

Overseen By Annie W Chan, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Active alcohol addiction, Pregnant, Metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6-8 weeks

45 Participants Needed

What You Need to Know Before You Apply

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

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.

Is IMRT or Proton Radiation Therapy safe for treating sinonasal cancer?

Both IMRT and Proton Radiation Therapy have been studied for sinonasal cancer, showing acceptable safety profiles. IMRT has been evaluated for therapy-related toxicity, while Proton Therapy is noted for reducing the risk of secondary cancers compared to other methods. ^{1 2 3 4 5}

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. ^{1 4 5 6 7}

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. ^{1 4 6 8 9}

Who Is on the Research Team?

Annie W. Chan

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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

My organs and bone marrow are functioning normally.

I have a confirmed advanced tumor in my sinus, nasal area, or related structures.

I am fully active or able to carry out light work.

Exclusion Criteria

I am allergic to medications similar to cisplatin.

I've been cancer-free for 2 years, except for certain skin, cervical, or breast cancers.

I have had radiation therapy for a tumor in my head, neck, skull base, or brain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily proton or IMRT radiation therapy, with optional concurrent standard chemotherapy

6-8 weeks

Daily visits for radiation therapy, weekly visits for side effect review and tests

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

First follow-up visit at 6-8 weeks, then every 3 months for 2 years, and every 6 months for years 3-5

What Are the Treatments Tested in This Trial?

Interventions

• Intensity-modulated radiotherapy
• Proton radiation therapy

Trial Overview The study compares intensity-modulated radiotherapy (IMRT) and proton radiation therapy to see which one is better at controlling cancer growth while causing fewer side effects in treating advanced sinonasal malignancy. It's the first prospective study of its kind on these treatments.

How Is the Trial Designed?

Group I: Proton beam therapy Active Control 1 Intervention

Subjects treated at Massachusetts General Hospital with proton beam therapy

Group II: IMRT Active Control 1 Intervention

Intensity-modulated radiation therapy at institutions other than Massachusetts General Hospital

Intensity-modulated radiotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as IMRT for:

• Head and neck cancers
• Brain tumors
• Prostate cancer

Approved in United States as IMRT for:

• Head and neck cancers
• Brain tumors
• Prostate cancer
• Breast cancer

Approved in Canada as IMRT for:

• Head and neck cancers
• Brain tumors
• Prostate cancer

Approved in Japan as IMRT for:

• Head and neck cancers
• Brain tumors
• Prostate cancer

Approved in China as IMRT for:

• Head and neck cancers
• Brain tumors
• Prostate cancer

Approved in Switzerland as IMRT for:

• Head and neck cancers
• Brain tumors
• Prostate cancer

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 36 patients treated with intensity-modulated radiation therapy (IMRT) for sinonasal malignancies, the 5-year overall survival rate was 45%, indicating that while disease control may not significantly improve, patients can have a reasonable chance of survival.

IMRT demonstrated a low incidence of complications, with minimal ocular toxicity reported and only a few cases of late complications, suggesting that this treatment is relatively safe for patients with these types of cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiation therapy for malignancies of the nasal cavity and paranasal sinuses. Daly, ME., Chen, AM., Bucci, MK., et al.[2006]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Carbon ion radiation therapy for sinonasal malignancies: Promising results from 2282 cases from the real world. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiotherapy for sinonasal tumors: Ghent University Hospital update. [2009]

3. United States pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiation therapy for malignancies of the nasal cavity and paranasal sinuses. [2006]

4. England pubmed.ncbi.nlm.nih.gov

Management of sinonasal cancers: Survey of UK practice and literature overview. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Treatment planning comparison of conventional, 3D conformal, and intensity-modulated photon (IMRT) and proton therapy for paranasal sinus carcinoma. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Intensity modulated radiotherapy (IMRT) in patients with carcinomas of the paranasal sinuses: clinical benefit for complex shaped target volumes. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Intensity modulated radiation therapy (IMRT) for sinonasal tumors: a single center long-term clinical analysis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Intensity Modulated Proton Therapy Better Spares Non-Adjacent Organs and Reduces the Risk of Secondary Malignant Neoplasms in the Treatment of Sinonasal Cancers. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

The role of intensity modulated radiation therapy for favorable stage tumor of the nasal cavity or ethmoid sinus. [2019]