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

Trial Summary

What is the purpose of this trial?

To learn if it is effective to use advanced radiation treatment techniques (stereotactic radiation or "SBRT") to safely deliver a strong dose of radiation to your tumor in a shorter period of time than would typically be feasible with traditional methods.

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.

What data supports the effectiveness of the treatment Stereotactic Body Radiation Therapy for head and neck cancer?

Research shows that Stereotactic Body Radiation Therapy (SBRT) is effective in treating recurrent head and neck cancers by delivering precise, high doses of radiation to target tumors while minimizing damage to surrounding healthy tissue. Studies have demonstrated its potential to improve local control and survival rates in patients with previously irradiated tumors. ^{1 2 3 4 5}

Is stereotactic body radiation therapy (SBRT) generally safe for humans?

Stereotactic body radiation therapy (SBRT), also known as stereotactic ablative radiotherapy (SABR), has been used to treat various cancers and is generally considered safe when performed with advanced technology and careful planning. However, some serious complications have been reported, so strategies to reduce these risks are important. ^{3 6 7 8 9}

How is the treatment Stereotactic Body Radiotherapy (SBRT) different from other treatments for head and neck cancer?

Stereotactic Body Radiotherapy (SBRT) is unique because it delivers high doses of radiation with high precision in just a few sessions, making it suitable for treating recurrent head and neck cancers, especially when previous treatments have already been used. It offers a shorter treatment schedule and can be safely administered in an outpatient setting, which can improve patient compliance and quality of life. ^{1 2 9 10 11}

Research Team

Jay Reddy, MD, PHD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

I am 18 years old or older.

Willing to provide informed consent

Exclusion Criteria

Pregnant or lactating women

I cannot undergo radiotherapy due to health reasons.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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]

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 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 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]

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 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 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]

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) 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]

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]

References

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

Survey of current practices from the International Stereotactic Body Radiotherapy Consortium (ISBRTC) for head and neck cancers. [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

The role of stereotactic body radiotherapy in reirradiation of head and neck cancer recurrence. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiosurgery for locally advanced or recurrent skull base malignancies with prior external beam radiation therapy. [2020]

4. United States 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. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiosurgery (SABR) or Stereotactic body radiation therapy (SBRT). [2022]

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

Serious complications associated with stereotactic ablative radiotherapy and strategies to mitigate the risk. [2018]

7. Poland pubmed.ncbi.nlm.nih.gov

A retrospective study on unresectable or inoperable head and neck cancers treated with stereotactic ablative brachytherapy. [2023]

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

Technical know-how in stereotactic ablative radiotherapy (SABR). [2022]

9. United States 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. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiotherapy (SBRT) for primary and recurrent head and neck tumors. [2015]

11. Ireland 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. [2019]