IMRT vs Proton Radiation Therapy for Sinonasal Cancer

Not currently recruiting at 1 trial location
EW
AW
Overseen ByAnnie W Chan, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two types of radiation therapy, Intensity-modulated radiotherapy (IMRT) and proton radiation, to determine which is more effective with fewer side effects for treating advanced sinonasal cancer. The goal is to identify whether one therapy controls the cancer more effectively without causing additional harm. Individuals with locally advanced sinonasal cancer, particularly those with tumors involving the nasal cavity, sinuses, or surrounding areas, may be suitable candidates. The study will use either IMRT or proton therapy, depending on the technology available at the treatment center. As an unphased trial, this study allows patients to contribute to important research that could enhance future cancer treatments.

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 prior data suggests that these radiation therapy techniques are safe for sinonasal cancer?

Research has shown that both proton radiation therapy and intensity-modulated radiotherapy (IMRT) are well-tolerated treatments for sinonasal cancer. Proton therapy is a safe and effective choice for sinonasal tumors, with side effects similar to other treatments and manageable in both the short and long term.

Similarly, IMRT is a safe and effective method for treating sinonasal cancer. Studies indicate that it produces good results without causing serious long-term side effects, and most patients tolerate it well.

In summary, research demonstrates that both proton radiation therapy and IMRT are safe, with manageable side effects.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for sinonasal cancer because they offer advanced ways to target tumors with precision. Intensity-modulated radiotherapy (IMRT) uses sophisticated technology to shape radiation beams, focusing on the tumor while minimizing damage to surrounding healthy tissue. Proton radiation therapy, on the other hand, uses protons instead of X-rays, delivering radiation with pinpoint accuracy and potentially reducing side effects even further. Both techniques aim to improve outcomes and quality of life for patients compared to traditional radiation therapy, which is less precise in sparing healthy tissues.

What evidence suggests that this trial's treatments could be effective for sinonasal cancer?

This trial will compare Intensity-modulated radiotherapy (IMRT) with Proton radiation therapy for treating sinonasal cancer. Research has shown that proton radiation therapy can effectively control sinonasal cancer over the long term. In one study, 77.5% of patients were alive three years after receiving proton therapy, and 59.6% did not experience cancer progression during this period. Proton therapy is generally well-tolerated and has improved outcomes compared to traditional radiation methods.

Similarly, intensity-modulated radiotherapy (IMRT) effectively treats sinonasal cancer. Studies have shown that 64% of patients did not develop distant cancer spread within three years, and 81% were still alive. IMRT is known for being both effective and safe, with good survival rates and few long-term side effects. Both treatments have shown promising results, but this trial aims to provide more clarity on which is better.12467

Who Is on the Research Team?

AW

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.
See 3 more

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.
See 5 more

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?
2Treatment groups
Active Control
Group I: Proton beam therapyActive Control1 Intervention
Group II: IMRTActive Control1 Intervention

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

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Approved in European Union as IMRT for:
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Approved in United States as IMRT for:
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Approved in Canada as IMRT for:
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Approved in Japan as IMRT for:
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Approved in China as IMRT for:
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Approved in Switzerland as IMRT for:

Find a Clinic Near You

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

Citations

Intensity modulated radiation therapy (IMRT) for sinonasal ...Intensity modulated radiation therapy (IMRT) represents an effective and safe treatment approach for patients with sinonasal carcinomas.
Intensity-modulated radiotherapy with carbon ion boost for ...Previous studies on CIRT of sinonasal cancer reported favorable local control and toxicity rates, compared to conventional RT for various tumor ...
Intensity modulated radiotherapy (IMRT) in patients with ...Distant metastases-free survival in patients treated with IMRT as primary RT was 83% after 1 and 64% after 3 years. For patients treated as primary irradiation ...
Intensity modulated radiation therapy (IMRT) for sinonasal tumorsIMRT produced acceptable 3-year outcomes in terms of OS, progression-free survival, LPFS, and RPFS rates without substantial late adverse effects, ...
Outcomes and toxicities of definitive radiotherapy and ...The 2-year local control (LC), distant control, disease-free survival, and overall survival rates were 83%, 84%, 74%, and 81%, respectively, for ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/26847089/
Intensity modulated radiation therapy (IMRT) for sinonasal ...Our data support the results of previous studies and indicate that intensity modulated radiation therapy (IMRT) represents an effective and ...
(PDF) Intensity modulated radiotherapy (IMRT) in patients ...Distant metastases-free survival in patients treated with IMRT as primary RT was 83% after 1 and 64% after 3 years. For patients treated as ...
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