Radiation Therapy for Tongue Cancer

Recruiting at 7 trial locations

Overseen By Nancy Lee, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Nodal disease, Positive nodes, Auto-immune, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 30

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of delivering radiation therapy for individuals who have undergone surgery for tongue cancer. The goal is to determine if avoiding radiation to the surgical site in the mouth can reduce side effects while still preventing cancer recurrence. Researchers will ask participants to complete surveys to assess how this treatment impacts their quality of life. This trial suits those who have had tongue cancer surgery, meet specific tumor and lymph node criteria, and currently show no visible cancer. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group.

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 team or your doctor.

What prior data suggests that this radiation therapy is safe for tongue cancer patients?

Research has shown that intensity-modulated radiation therapy (IMRT) effectively treats head and neck cancers, such as tongue cancer, by delivering precise radiation doses. This method targets cancer cells while protecting healthy areas. Studies have found that IMRT can lead to good results and reduce side effects, such as painful mouth inflammation and the need for pain medication.

While patients generally tolerate IMRT well, some side effects, like mild to moderate discomfort in treated areas, can occur. Research suggests that IMRT is safer for many patients compared to other radiation methods.

This trial is in Phase 2, indicating that initial safety has been checked, but researchers are still studying how well participants handle this treatment. Participants will be monitored for any side effects, and doctors will ensure the treatment remains as safe as possible. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Photon intensity modulated radiation therapy (IMRT) is unique because it delivers precise doses of radiation to tongue cancer cells while minimizing exposure to surrounding healthy tissue. Unlike traditional radiation methods, which can affect both cancerous and non-cancerous areas, IMRT uses advanced technology to shape radiation beams to the contours of the tumor. This targeted approach can potentially reduce side effects and improve the quality of life for patients. Researchers are excited about IMRT because it offers a promising way to balance treatment effectiveness with patient comfort.

What evidence suggests that photon intensity modulated radiation therapy (IMRT) might be an effective treatment for tongue cancer?

Research has shown that intensity-modulated radiotherapy (IMRT) effectively treats head and neck cancers, including tongue cancer. Studies indicate that IMRT delivers precise radiation, targeting cancer cells while protecting healthy tissue. This trial will use IMRT to treat participants, and previous research demonstrated 5-year survival rates between 60% and 75%, offering better cancer control. Additionally, research found that IMRT can be adjusted to avoid the oral tongue area, potentially reducing side effects while still treating necessary areas. Overall, IMRT is a promising treatment for effectively managing tongue cancer. ^{2 3 6 7 8}

Who Is on the Research Team?

Sean McBride, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals who have undergone surgery for oral tongue squamous cell carcinoma. Participants should be those who are now considering radiation therapy as the next step in their treatment.

Inclusion Criteria

My cancer has at least two high-risk features based on my pathology report.

My tongue cancer is in an early stage and has not spread widely.

Signed informed consent form by the participant or their legally authorized representative (LAR)

Exclusion Criteria

I have more than two lymph nodes with cancer.

My cancer surgery margins were less than 3 mm.

My cancer has spread along my nerves.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive bilateral cervical nodal irradiation with the primary post operative site excluded (30 fractions)

6 weeks

30 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of local failure and quality of life

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Photon intensity modulated radiation therapy (IMRT)

Trial Overview

The study is testing a modified form of photon intensity modulated radiation therapy (IMRT) that avoids the surgical site on the oral tongue, aiming to reduce side effects and assess its impact on cancer recurrence and quality of life.

How Is the Trial Designed?

Group I: Radiation Therapy Experimental Treatment 2 Interventions

These patients will then receive bilateral cervical nodal irradiation with the primary post operative site excluded (30 fractions). They will be monitored for both physician reported toxicities.

Photon intensity modulated radiation therapy (IMRT) is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Intensity Modulated Radiation Therapy for:

• Head and neck cancer
• Brain tumors
• Breast cancer
• Esophageal cancer
• Gynecological cancers
• Liver cancer
• Lung cancer
• Pancreatic cancer
• Prostate cancer

Approved in United States as Intensity Modulated Radiation Therapy for:

• Head and neck cancer
• Brain tumors
• Breast cancer
• Esophageal cancer
• Gynecological cancers
• Liver cancer
• Lung cancer
• Pancreatic cancer
• Prostate cancer

Approved in Canada as Intensity Modulated Radiation Therapy for:

• Head and neck cancer
• Brain tumors
• Breast cancer
• Esophageal cancer
• Gynecological cancers
• Liver cancer
• Lung cancer
• Pancreatic cancer
• Prostate cancer

Approved in Japan as Intensity Modulated Radiation Therapy for:

• Head and neck cancer
• Brain tumors
• Breast cancer
• Esophageal cancer
• Gynecological cancers
• Liver cancer
• Lung cancer
• Pancreatic cancer
• Prostate cancer

Approved in China as Intensity Modulated Radiation Therapy for:

• Head and neck cancer
• Brain tumors
• Breast cancer
• Esophageal cancer
• Gynecological cancers
• Liver cancer
• Lung cancer
• Pancreatic cancer
• Prostate cancer

Approved in Switzerland as Intensity Modulated Radiation Therapy for:

• Head and neck cancer
• Brain tumors
• Breast cancer
• Esophageal cancer
• Gynecological cancers
• Liver cancer
• Lung cancer
• Pancreatic cancer
• Prostate cancer

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

Intensity-modulated radiotherapy (IMRT) after surgery for oral cavity cancer showed promising effectiveness, with 2- and 3-year overall survival rates of 74% and 74%, respectively, among 35 patients studied over a median follow-up of 28.1 months.

While IMRT was effective, some patients experienced significant side effects, including acute dermatitis (54%) and mucositis (66%), but the overall toxicity was considered acceptable for the benefits gained.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiotherapy in postoperative treatment of oral cavity cancers. Gomez, DR., Zhung, JE., Gomez, J., et al.[2022]

Intensity-modulated radiation therapy (IMRT) is a cutting-edge technique in radiotherapy that allows for highly precise targeting of tumors while minimizing damage to surrounding healthy tissues, particularly beneficial for complex shapes like those found in head-and-neck cancers.

The review discusses the authors' clinical experience with IMRT in treating 126 patients, highlighting the effectiveness of their serial tomotherapy techniques in improving treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical experience of head-and-neck cancer IMRT with serial tomotherapy. Ozyigit, G., Chao, KS.[2019]

Intensity-modulated radiation therapy (IMRT) shows promise in treating head and neck cancer by delivering precise radiation doses, which may reduce side effects compared to traditional methods.

While advancements in IMRT techniques and target selection are being made, there is still a lack of mature clinical data to fully establish its safety and efficacy in head and neck cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiation therapy in the management of head and neck cancer. Hong, TS., Tomé, WA., Harari, PM.[2019]

Intensity-modulated radiation therapy (IMRT) significantly reduced the incidence of late xerostomia (dry mouth) in patients with oropharyngeal cancer compared to conventional radiation therapy (CRT), indicating a safety advantage for IMRT.

The study, which followed 430 patients over a median of 3.9 years, found that IMRT did not negatively affect tumor control or disease-free survival rates, demonstrating its efficacy in treating oropharyngeal carcinoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiation therapy reduces late salivary toxicity without compromising tumor control in patients with oropharyngeal carcinoma: a comparison with conventional techniques. Chao, KS., Majhail, N., Huang, CJ., et al.[2022]

In a case series of 4 patients with stage III to IV oral tongue cancer, all experienced locoregional recurrence in areas that were not targeted by intensity-modulated radiotherapy (IMRT), suggesting that selective targeting may lead to marginal failures.

The median time to recurrence was relatively short at 3.9 months, indicating that selective radiation targeting may not provide adequate coverage and raises concerns about its safety and efficacy in treating oral tongue cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Marginal recurrences after selective targeting with intensity-modulated radiotherapy for oral tongue cancer. Damast, S., Wolden, S., Lee, N.[2022]

Intensity-modulated radiation therapy (IMRT) allows for more precise radiation delivery in head and neck cancers, improving local control of tumors while minimizing damage to critical structures like the spine and parotid glands.

IMRT has been shown to preserve salivary function by sparing the parotid glands, although there are ongoing concerns about potential side effects, such as difficulties with swallowing and the risk of secondary cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiotherapy for head and neck cancer. Caglar, HB., Allen, AM.[2007]

The SMART technique for intensity modulated radiotherapy (IMRT) significantly reduces maximum and mean radiation doses to the skin and oral cavity in head and neck cancer patients, while maintaining acceptable coverage of the planning target volume (PTV).

In a study of 16 patients, the SMART technique reduced skin maximum doses from 64.2 Gy to 55.9 Gy and mean doses from 26.7 Gy to 20.2 Gy, indicating a potential for less treatment-related morbidity, particularly in skin toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skin/mucosa avoidance radiotherapy (SMART) versus conventional volumetric arc-based radiotherapy (VMAT) for the treatment of head and neck cancer: Dosimetric feasibility study. Anderson, C., MacDonald, RL., Wilke, D.[2023]

Intensity modulated radiation therapy (IMRT) and brachytherapy are established methods for treating oral cavity cancers, providing targeted irradiation to improve treatment outcomes.

The paper outlines essential aspects of these techniques, including patient preparation, volume selection, dosimetry, and positioning control, which are crucial for effective cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Radiotherapy for oral cavity cancers]. Lapeyre, M., Biau, J., Racadot, S., et al.[2018]

Intensity-modulated radiation therapy (IMRT) significantly reduces the risk of moderate to severe acute and late xerostomia (dry mouth) by 36% and 56% respectively compared to conventional 2D/3D radiotherapy in patients with head and neck squamous cell carcinoma (HNSCC), based on a review of 7 randomized controlled trials involving 1155 patients.

While IMRT shows a potential 24% reduction in loco-regional relapse and a 30% reduction in mortality risk compared to 2D/3D-RT, these benefits were primarily observed in nasopharyngeal cancer patients, indicating variability in effectiveness based on cancer location.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analyses of intensity-modulated radiation therapy versus conventional two-dimensional and/or or three-dimensional radiotherapy in curative-intent management of head and neck squamous cell carcinoma. Gupta, T., Kannan, S., Ghosh-Laskar, S., et al.[2022]

Intensity-modulated radiotherapy (IMRT) has been shown to significantly reduce toxicity-related side effects compared to conventional radiotherapy in various cancers, including head and neck and breast cancers, based on evidence from 61 studies involving over 7,000 patients.

IMRT not only maintains better quality of life by preserving functions like saliva production in head and neck cancer patients but also allows for safer dose escalation in prostate cancer, indicating its efficacy in improving treatment outcomes across multiple tumor sites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the clinical evidence for intensity-modulated radiotherapy. Staffurth, J.[2022]

Intensity-modulated radiotherapy (IMRT) offers significantly higher conformality in dose distribution compared to conventional 3-D conformal radiotherapy (3-DCRT), making it particularly beneficial for treating head and neck cancers where precise dosage is crucial.

IMRT allows for higher doses to be delivered to primary tumors while sparing surrounding healthy tissues, which can improve treatment outcomes and reduce side effects, especially in the context of recurrent head and neck malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiotherapy for carcinoma of the head and neck. Peñagarícano, JA., Papanikolaou, N.[2019]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5474304/

Intensity modulated proton beam therapy (IMPT) versus ...

IMPT used for oropharyngeal carcinoma patients has the ability to reduce the dose to organs at risk compared to intensity-modulated radiotherapy (IMRT) while ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2331518023002421

Dosimetric Comparison of Intensity-Modulated Radiation ...

This study quantifies the feasibility and dosimetric advantages of oral tongue avoidance while still treating the at-risk lymph nodes for oral tongue cancer.

3.

withpower.com

withpower.com/trial/phase-2-carcinoma-5-2024-99531

Radiation Therapy for Tongue Cancer

Intensity-modulated radiotherapy (IMRT) is shown to be effective in treating head and neck cancers, including oral cavity cancers, by delivering precise ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12287490/

Advances in radiotherapy for mouth neoplasms

Intensity-modulated radiotherapy, for example, has demonstrated 5-year overall survival rates ranging from 60 to 75%, with better local control ...

5.

thegreenjournal.com

thegreenjournal.com/article/S0167-8140(16)31136-7/fulltext

Intensity-modulated proton beam therapy (IMPT) versus ...

Three-year distant control rates were 97.8% for IMPT patients and 93.5% for IMRT patients. No significant differences were found between the ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S0167814016311367

Intensity-modulated proton beam therapy (IMPT) versus ...

Our results suggest that IMPT is associated with reduced rates of feeding tube dependency and severe weight loss without jeopardizing outcome.

7.

dfs.ny.gov

dfs.ny.gov/public-appeals/case-number-202209-153954

Case Number: 202209-153954 | Department of Financial Services

1) Intensity-Modulated Proton Therapy (IMPT) versus Intensity-Modulated Photon Radiotherapy (IMRT) for Oropharyngeal Cancer: First Comparative Results of ...

8.

mdpi.com

mdpi.com/2072-6694/13/7/1549

Early Clinical Outcomes of Intensity Modulated Radiation ...

We found that, with comparable oncologic outcomes, more favorable acute toxicity profiles (mucositis and need for analgesic use) were achieved following IMRT/ ...