Stereotactic Body Radiation Therapy for Head and Neck Cancer

Overseen By Jay Reddy, MD,PHD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnant, Lactating, Radiotherapy contraindications

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 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3-5 fractions

108 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if stereotactic body radiotherapy (SBRT), a special type of radiation therapy, can safely and effectively deliver a high dose of radiation to head and neck tumors more quickly than standard methods. Participants will receive either SBRT or traditional radiation treatment, assigned randomly. The trial seeks individuals with squamous cell carcinoma in the head or neck who have previously undergone treatments like radiation or surgery but cannot receive further curative treatment. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in cancer treatment.

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 is best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that stereotactic body radiotherapy (SBRT) is usually well-tolerated for some types of cancer. It can be safely used in patients with a few small tumors, known as oligometastatic disease, meaning it works for those with a limited number of cancer spots.

Some studies have explored using SBRT for head and neck cancers, but data remains limited. Available information suggests that SBRT might be a safe option for these cancers, but more research is needed to confirm this.

This trial is in Phase 2, indicating that the treatment has already shown some safety in earlier trials. However, since researchers are still studying SBRT specifically for head and neck cancer, there might be some risks or side effects that are not yet fully understood. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Stereotactic Body Radiotherapy (SBRT) for head and neck cancer because it offers a highly precise and targeted approach compared to traditional radiation therapy. Unlike conventional treatments that often involve multiple sessions over weeks, SBRT delivers high doses of radiation in fewer sessions, potentially reducing treatment time and side effects. This precision targets cancer cells while sparing healthy tissues, which could lead to better outcomes and improved quality of life for patients.

What evidence suggests that this trial's treatments could be effective for head and neck cancer?

This trial will compare Stereotactic Body Radiotherapy (SBRT) with Traditional Palliation for head and neck cancer. Studies have shown that SBRT can be effective for this type of cancer. SBRT delivers high doses of radiation directly to the tumor with great accuracy, allowing for shorter treatment times while precisely targeting the cancer. Some research suggests that SBRT could serve as an additional treatment for these cancers, although it is not yet widely used. Early evidence indicates it may improve outcomes by concentrating more radiation on cancerous areas while protecting healthy tissue. Overall, SBRT shows promise as a treatment option for head and neck cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Jay Reddy, MD, PHD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with squamous cell carcinoma in the head and neck region, who can't have curative treatment. They may have had previous treatments but are not eligible for further radiation as per their doctor's assessment. Pregnant or breastfeeding women cannot participate, and participants must consent to detailed examinations and provide a smoking history.

Inclusion Criteria

My cancer cannot be cured with surgery or radiation, as decided by a team of doctors.

Willing to provide informed consent

My cancer has spread to other parts of my body.

Exclusion Criteria

Pregnant or lactating women

I cannot undergo radiotherapy due to health reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either stereotactic body radiotherapy (SBRT) or traditional radiation for palliation of head and neck squamous cell carcinoma

3-5 fractions

Follow-up

Participants are monitored for safety, symptom burden, and progression-free survival after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Body Radiotherapy
• Traditional Palliation

Trial Overview The study is testing whether stereotactic body radiotherapy (SBRT) can deliver high doses of radiation effectively over a shorter period compared to traditional palliative methods. Participants will be randomly assigned to receive either SBRT or conventional palliation.

How Is the Trial Designed?

Group I: Traditional Palliation Experimental Treatment 1 Intervention

Participant will be randomized to standard radiation

Group II: Stereotactic body radiotherapy (SBRT) Experimental Treatment 1 Intervention

Participants will be randomized to receive (SBRT) Stereotactic body radiotherapy.

Stereotactic Body Radiotherapy is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Stereotactic Body Radiation Therapy for:

• Lung cancer
• Liver cancer
• Spine tumors
• Pancreatic cancer
• Prostate cancer

Approved in United States as Stereotactic Body Radiation Therapy for:

• Early-stage lung cancer
• Liver cancer
• Spine tumors
• Pancreatic cancer
• Prostate cancer

Approved in Canada as Stereotactic Body Radiation Therapy for:

• Lung cancer
• Liver cancer
• Spine tumors
• Pancreatic cancer
• Prostate cancer

Approved in Japan as Stereotactic Body Radiation Therapy for:

• Lung cancer
• Liver cancer
• Spine tumors
• Pancreatic cancer
• Prostate cancer

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

Stereotactic body radiotherapy (SBRT) is primarily used for recurrent head and neck cancer, with usage rates ranging from 10% to 100%, while it is rarely applied to newly diagnosed cases (0-10%).

There is significant variability in treatment techniques and patient selection among 15 international institutions, including differences in target volume margins and fractionation regimens, which may impact treatment outcomes and safety, such as the risk of carotid blowout ranging from 3% to 20% in re-irradiation cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey of current practices from the International Stereotactic Body Radiotherapy Consortium (ISBRTC) for head and neck cancers. Karam, I., Yao, M., Heron, DE., et al.[2018]

Stereotactic Body Radiotherapy (SBRT) is a highly effective and well-tolerated treatment for recurrent and previously irradiated head and neck tumors, offering a favorable alternative to traditional salvage therapies.

SBRT provides the benefits of a shorter treatment schedule and can be safely administered in an outpatient setting, making it a promising option for definitive treatment in select patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiotherapy (SBRT) for primary and recurrent head and neck tumors. Lim, CM., Clump, DA., Heron, DE., et al.[2015]

Stereotactic body radiotherapy (SBRT) is a safe and feasible treatment option for patients with recurrent squamous cell carcinoma of the head and neck, showing minimal toxicities and no severe treatment-related side effects (grade 4 or 5).

In a study of 85 patients, SBRT resulted in a 1-year local control rate of 51.2% and a median overall survival of 11.5 months, with better outcomes observed in patients receiving doses of 35 Gy or higher.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractionated stereotactic body radiation therapy in the treatment of previously-irradiated recurrent head and neck carcinoma: updated report of the University of Pittsburgh experience. Rwigema, JC., Heron, DE., Ferris, RL., et al.[2019]

Stereotactic body radiotherapy (SBRT) at doses up to 44 Gy was found to be safe for previously irradiated patients with squamous cell carcinoma of the head and neck, with no severe toxicities reported and only mild acute side effects in four patients.

The treatment showed a 17% objective response rate, with some patients experiencing stable disease for up to 4 months, suggesting that SBRT could be a viable option for reirradiation in this patient population, warranting further studies alongside other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for recurrent squamous cell carcinoma of the head and neck: results of a phase I dose-escalation trial. Heron, DE., Ferris, RL., Karamouzis, M., et al.[2022]

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 31 patients with previously irradiated malignant skull base tumors treated with stereotactic ablative radiotherapy (SABR), the treatment demonstrated low toxicity, with no severe (grade 4 or 5) side effects reported.

The estimated 1-year overall survival rate was 35%, indicating that while SABR is well-tolerated, the survival outcomes for these patients remain limited, with a median time-to-progression of 3.3 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiosurgery for locally advanced or recurrent skull base malignancies with prior external beam radiation therapy. Xu, KM., Quan, K., Clump, DA., et al.[2020]

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]

Stereotactic body radiotherapy (SBRT) shows promise as a treatment for recurrent head and neck cancer, demonstrating efficacy comparable to traditional combinations of radiotherapy and chemotherapy, based on retrospective studies and phase I-II trials.

The treatment has been associated with low to moderate toxicity, making it a potentially safer option for selected patients with recurrent head and neck cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of stereotactic body radiotherapy in reirradiation of head and neck cancer recurrence. Román A, A., Jodar, C., Perez-Rozos, A., et al.[2018]

Stereotactic ablative brachytherapy (SABT) demonstrated good local control rates for unresectable or inoperable head and neck cancers, with local control rates of 89.2% at 6 months and 69.4% at 24 months, based on a study of 37 patients over a median follow-up of 34 months.

The treatment was found to be safe, with only mild adverse reactions reported in 29.7% of patients, and no severe complications (grade 3 or higher), indicating that SABT is a minimally invasive option with fewer side effects compared to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective study on unresectable or inoperable head and neck cancers treated with stereotactic ablative brachytherapy. Zhao, G., Wang, Z., Li, C., et al.[2023]

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 of 150 patients with unresectable recurrent squamous cell carcinomas of the head and neck, stereotactic body radiotherapy (SBRT) significantly improved patient-reported quality of life (PR-QoL) after an initial decline, particularly in areas like swallowing, speech, and saliva production.

The improvements in PR-QoL were noted across all measured domains and were especially pronounced in patients who survived more than one year, suggesting that SBRT can effectively enhance quality of life while providing tumor control in previously irradiated areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective evaluation of patient-reported quality-of-life outcomes following SBRT ± cetuximab for locally-recurrent, previously-irradiated head and neck cancer. Vargo, JA., Heron, DE., Ferris, RL., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10999469/

Stereotactic ablative radiotherapy for treating primary head ... The indication for stereotactic ablative radiotherapy in head and neck remains rare. Emerging data demonstrate a possible utility of SABR as a boost.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7774675/

A systematic review and practical considerations of ... A systematic review and practical considerations of stereotactic body radiotherapy in the treatment of head and neck cancer. Muhammad Shahid Iqbal ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0360301624037714

Pulmonary Stereotactic Body Radiation Therapy of ... This study aimed to evaluate the outcomes of pulmonary SBRT in patients with oligometastatic HNSCC and to identify factors associated with survival.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2452109422002299

Efficacy and Safety of Stereotactic Body Radiation Therapy ... Limited data are currently available on clinical outcomes after stereotactic body radiation therapy (SBRT) for pediatric and adolescent and young adult ...

5. treatcancer.com treatcancer.com/stereotactic-body-radiotherapy-sbrt/

Stereotactic Body Radiotherapy (SBRT) In Charlotte | SERO Stereotactic Body Radiotherapy (SBRT) is a specialized form of radiation therapy that delivers precise doses of radiation to a small area within the body.

6. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2778658

Evaluation of Safety of Stereotactic Body Radiotherapy for ... Standard ablative radiation schedules appear to be safe for patients with oligometastatic disease with 3 to 4 metastases or 2 metastases in close proximity to ...

7. advancesradonc.org advancesradonc.org/article/S2452-1094(24)00002-2/fulltext

Clinical Outcomes Among Patients Treated With ... There are limited data regarding outcomes after stereotactic body radiation therapy (SBRT) for femur metastases, which was an exclusion criteria.