Stereotactic Radiotherapy for Laryngeal Cancer

Recruiting at 1 trial location

Overseen By Jack Phan, MD, PHD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Immunosuppressants, Chemotherapy

Disqualifiers: Prior cancer, Prior radiation, Metastatic, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 2 weeks

11 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new radiation treatment called stereotactic hypofractionated radioablation (HYDRA) for individuals with laryngeal cancer. The researchers aim to determine the highest safe dose while monitoring safety. Participants will receive the treatment over five sessions within approximately two weeks and complete questionnaires over several months to track their experience. This trial suits those with squamous cell carcinoma of the larynx who have not yet undergone surgery or chemotherapy for this cancer. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify if 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 stereotactic hypofractionated radioablation is safe for laryngeal cancer?

Research has shown that stereotactic hypofractionated radioablation (HYDRA) is generally safe for treating early-stage laryngeal cancer. One study found this treatment both safe and effective for early-stage larynx cancer, with patients reporting positive outcomes. Another study confirmed that similar radiation therapy is safe and practical for treating early-stage cancer in the voice box.

These findings suggest that HYDRA is usually well-tolerated, with most people not experiencing severe side effects. However, as the current trial is still in its early stages, researchers are testing to find the safest dose. They aim to determine how much radiation patients can receive without experiencing too many side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for laryngeal cancer, such as traditional radiotherapy or surgery, Stereotactic Hypofractionated Radioablation (HYDRA) offers a more precise and targeted approach. This technique involves delivering high doses of radiation directly to the tumor over just five sessions within about two weeks. Researchers are excited about HYDRA because its precision minimizes damage to surrounding healthy tissue, potentially reducing side effects and recovery time. Additionally, the shorter treatment duration could improve patient convenience and quality of life compared to conventional therapies.

What evidence suggests that stereotactic hypofractionated radioablation is effective for laryngeal cancer?

Research shows that a new type of radiation therapy, stereotactic hypofractionated radioablation (HYDRA), holds promise for treating early-stage glottic larynx cancer. Studies have found this treatment safe and effective at shrinking tumors in the voice box. It precisely targets the cancer, protecting nearby healthy tissues. Patients have reported good results, indicating that HYDRA can successfully treat laryngeal cancer. Research continues to determine the optimal treatment dose, but early results are encouraging. ^{1 4 5 6 7}

Who Is on the Research Team?

Jack Phan, MD,PHD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Adults over 18 with laryngeal cancer (specifically squamous cell carcinoma) at certain stages, who can understand English and consent to the study. They must be fit for a specific surgery, agree to use contraception, and not have had prior head/neck radiation or recent potent immunosuppressive drugs.

Inclusion Criteria

Ability to understand English language and the willingness to sign a written informed consent

I am considered fit for a specific throat surgery by my doctor.

I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

Patients unable or unwilling to give written, informed consent

My cancer has spread to other parts of my body.

I have received initial chemotherapy for my cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive HYDRA radiation on up to 5 days over the course of about 2 weeks

2 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

3 visits (in-person) at 6 weeks, 3 months, and 6 months

Long-Term Follow-Up

Participants are monitored every 3 months for the first 2 years, and then every 6 months for up to 5 years

5 years

Regular visits every 3-6 months

What Are the Treatments Tested in This Trial?

Interventions

• Questionnaires
• Stereotactic Hypofractionated Radioablation

Trial Overview The trial is testing the highest dose of HYDRA radiation that's safe for laryngeal cancer patients. It involves giving focused high-dose radiation in fewer sessions than traditional therapy and includes completing questionnaires about the experience.

How Is the Trial Designed?

Group I: Stereotactic Hypofractionated Radioablation (HYDRA) Experimental Treatment 2 Interventions

Participants receive HYDRA radiation on up to 5 days over the course of about 2 weeks, and for a total of 5 times. Questionnaires completed at Baseline, on days receiving HYDRA, 6 weeks after last dose of HYDRA, 3 months after last dose of HYDRA, and 6 months after last dose of HYDRA. Also after the 6 month follow-up visit, every 3 months for the first 2 years, and then every 6 months after that for up to 5 years.

Stereotactic Hypofractionated Radioablation is already approved in United States, European Union for the following indications:

Approved in United States as Stereotactic Hypofractionated Radioablation for:

• Laryngeal cancer

Approved in European Union as Stereotactic Hypofractionated Radioablation for:

• Laryngeal cancer
• Head and neck cancers

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Cancer Prevention Research Institute of Texas

Collaborator

Trials

55

Recruited

98,900+

Published Research Related to This Trial

Stereotactic ablative body radiosurgery (SABR) and stereotactic body radiation therapy (SBRT) deliver high doses of radiation precisely to tumors, which may improve treatment outcomes compared to conventional low-dose radiation therapy (1.8-2Gy).

These advanced techniques not only enhance tumor ablation but also interact beneficially with biological and immunologic therapies, while incorporating methods to protect normal tissues, making them suitable for various types of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiosurgery (SABR) or Stereotactic body radiation therapy (SBRT). Folkert, MR., Timmerman, RD.[2022]

In a study assessing the effects of stereotactic ablative body radiotherapy (SABR) on a patient with a solitary kidney, renal function declined significantly, showing a 34% decrease at 3 months and stabilizing at a 43% loss by 12 months after receiving a single dose of 26 Gy.

The research indicates a clear dose-effect relationship, where the extent of kidney function loss correlates with the radiation dose delivered, highlighting the need for careful consideration of SABR's impact on healthy renal tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short communication: timeline of radiation-induced kidney function loss after stereotactic ablative body radiotherapy of renal cell carcinoma as evaluated by serial (99m)Tc-DMSA SPECT/CT. Jackson, P., Foroudi, F., Pham, D., et al.[2022]

Stereotactic ablative body radiotherapy (SABR) has shown a local control rate of over 90% in treating primary renal cell carcinoma (RCC) across 589 cases, with low rates of severe toxicity (grade 3-4) ranging from 0-9%.

In patients with oligometastatic RCC, SABR can delay the need for systemic therapy for at least one year in 70-90% of cases, indicating its effectiveness as a treatment option and its compatibility with systemic therapies like targeted therapy or immunotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Stereotactic Ablative Body Radiotherapy in Renal Cell Carcinoma. Ali, M., Mooi, J., Lawrentschuk, N., et al.[2022]

Stereotactic ablative radiotherapy (SABR) is a well-tolerated and effective treatment for primary renal cell carcinoma, showing high rates of local control (97.8%) and cancer-specific survival (95.7%) at 2 years among 223 patients studied across multiple institutions.

Patients receiving single-fraction SABR had better progression-free survival and cancer-specific survival compared to those receiving multifraction SABR, suggesting that single-fraction treatment may be more beneficial for certain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pooled analysis of stereotactic ablative radiotherapy for primary renal cell carcinoma: A report from the International Radiosurgery Oncology Consortium for Kidney (IROCK). Siva, S., Louie, AV., Warner, A., et al.[2022]

Stereotactic ablative radiation therapy (SABR) for stage I lung cancer at Sheba Medical Center showed a median overall survival of 46 months and a 3-year survival rate of 59%, indicating its efficacy as a treatment for inoperable patients.

The treatment demonstrated excellent local control at 88% and had manageable toxicity, with only 8.4% of patients experiencing chest wall pain and a low incidence of severe side effects, suggesting it is a safe option for patients with early-stage lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Body Radiation for Stage I Lung Cancer in Israel: A Retrospective Single-Center Report. Appel, S., Lawrence, YR., Goldstein, J., et al.[2022]

Stereotactic ablative body radiotherapy (SABR) has been shown to be an effective long-term treatment for primary renal cell carcinoma, with a low local failure rate of 5.5% at 5 years among 190 patients studied across multiple countries.

The study found that single-fraction SABR resulted in fewer local failures compared to multifraction SABR, and importantly, there were no severe treatment-related side effects or deaths, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

5-year outcomes after stereotactic ablative body radiotherapy for primary renal cell carcinoma: an individual patient data meta-analysis from IROCK (the International Radiosurgery Consortium of the Kidney). Siva, S., Ali, M., Correa, RJM., et al.[2023]

Stereotactic ablative radiotherapy (SABR) has rapidly expanded in clinical use for treating various primary and metastatic tumors, demonstrating promising results in tumor control.

Despite its effectiveness, SABR can lead to serious complications, highlighting the need for strategies to reduce these risks and improve the safety of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious complications associated with stereotactic ablative radiotherapy and strategies to mitigate the risk. Lo, SS., Sahgal, A., Chang, EL., et al.[2018]

Hypofractionated stereotactic body radiation therapy (SBRT) for early-stage glottic laryngeal cancer is safe and feasible, with a significant reduction in treatment duration from 15 to 5 fractions while maintaining acceptable toxicity levels.

After a median follow-up of 13.4 months, the treatment showed an 82% local disease-free survival rate and a 100% overall survival rate, indicating promising efficacy comparable to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SBRT for early-stage glottic larynx cancer-Initial clinical outcomes from a phase I clinical trial. Schwartz, DL., Sosa, A., Chun, SG., et al.[2018]

Stereotactic ablative radiotherapy (SABR) is a promising treatment option for extracranial tumors, demonstrating both safety and effectiveness when applied with strict adherence to technical guidelines.

The treatment has a very narrow therapeutic window, meaning precise delivery is crucial for maximizing its benefits while minimizing risks to surrounding healthy tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical know-how in stereotactic ablative radiotherapy (SABR). Lo, SS., Foote, M., Siva, S., et al.[2022]

In a study of 137 patients with recurrent head and neck cancer treated with stereotactic body radiotherapy (SBRT), the median overall survival was 44.3 months, indicating a potentially effective treatment option for this challenging condition.

The addition of systemic therapy significantly improved regional and distant control of the cancer, although it was associated with higher rates of severe toxicities, particularly at mucosal sites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body ablative radiotherapy for reirradiation of small volume head and neck cancers is associated with prolonged survival: Large, single-institution, modern cohort study. Diao, K., Nguyen, TP., Moreno, AC., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12147862/

Stereotactic Ablative Radiotherapy for T1 to T2 Glottic ... Highly conformal stereotactic radiation therapy appears safe and efficacious for early-stage glottic larynx cancer, with encouraging patient-reported outcomes.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301624029729

Stereotactic Ablative Radiotherapy for T1 to T2 Glottic ... Highly conformal stereotactic radiation therapy appears safe and efficacious for early-stage glottic larynx cancer, with encouraging patient-reported outcomes.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03114462

Trial of Stereotactic HYpofractionateD RadioAblative ... To find the highest tolerable dose of stereotactic hypofractionated radioablation (HYDRA) radiation that can be given to patients with laryngeal cancer. The ...

4. withpower.com withpower.com/trial/phase-1-carcinoma-squamous-cell-7-2017-06d7d

Stereotactic Radiotherapy for Laryngeal Cancer Hypofractionated stereotactic body radiation therapy (SBRT) for early-stage glottic laryngeal cancer is safe and feasible, with a significant reduction in ...

5. ctro.science ctro.science/article/S2405-6308(24)00043-0/fulltext

Stereotactic ablative radiotherapy for treating primary head ... SABR is an innovative, effective and promising treatment modality for small targets, especially in near proximity to organs at risk or in a pre-irradiated ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12268857/

Stereotactic ablative body radiation therapy for treatment of ... SABR is emerging as a promising treatment for patients with UC lung lesions. There is an urgent need for a standardized definition of UC tumors.

7. redjournal.org redjournal.org/article/S0360-3016(24)00508-X/fulltext

Safety and Efficacy of Stereotactic Body Radiation Therapy ... We sought to evaluate the toxicity and efficacy of stereotactic body radiation therapy (SBRT) for ultracentral thoracic tumors at our institution.