Stereotactic vs Standard Radiotherapy for Head and Neck Cancer

Recruiting at 1 trial location

Overseen By Wendy Parulekar

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Canadian Cancer Trials Group

Must not be taking: Immunotherapy

Disqualifiers: Nasopharyngeal carcinoma, Prior head/neck cancer, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

196 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether a new type of radiation therapy, stereotactic body radiation therapy (SBRT), can better control advanced head and neck cancer compared to standard radiotherapy (SRT). It targets individuals with specific types of head and neck cancer who cannot undergo the standard curative treatment. Eligible participants should have a diagnosis of a specific type of head and neck cancer and be unable to receive the usual curative radiation therapy. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking 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's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that Stereotactic Body Radiotherapy (SBRT) is usually well-tolerated. In past studies, patients with head and neck cancer who received SBRT generally experienced no major safety issues. For instance, one study noted promising survival rates and manageable side effects. Another study found that while some cancer recurrences occurred, the treatment's side effects remained acceptable. These findings suggest that SBRT is a relatively safe treatment option for head and neck cancer. However, as with any treatment, individual experiences can differ, so discussing potential risks with a healthcare provider is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for head and neck cancer?

Researchers are excited about Stereotactic Body Radiotherapy (SBRT) for head and neck cancer because it offers a more precise and targeted approach compared to the standard radiotherapy. While standard radiotherapy often involves treating larger areas, which can affect healthy tissues, SBRT delivers high doses of radiation directly to the tumor with pinpoint accuracy. This precision potentially reduces side effects and improves patient outcomes by sparing more of the surrounding healthy tissue. Additionally, SBRT can be completed in fewer sessions, offering a more convenient option 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 Standard Radiotherapy (SRT) for treating advanced head and neck cancer. Research has shown that SBRT might be effective. One study reported that 70.4% of patients treated with SBRT were cancer-free after 24 months, and 76.4% were still alive. These promising results suggest that SBRT can help control cancer growth. SBRT also targets tumors precisely while protecting important organs, helping to maintain quality of life. Although cancer can return, the potential benefits make SBRT a treatment worth considering. ^{4 6 7 8 9}

Who Is on the Research Team?

Ian Poon

Principal Investigator

Odette Cancer Centre, Sunnybrook Health Sciences, UHN, Toronto, ON Canada

Are You a Good Fit for This Trial?

This trial is for adults with advanced head and neck cancer who are unfit for curative radiation therapy. They must have a specific type of cancer (SCC) from certain areas, be in any stage T0-T4/N0-N3, have an ECOG status 0-3 indicating varying levels of function, and agree to use effective contraception if childbearing potential exists.

Inclusion Criteria

My cancer is a type of squamous cell carcinoma located in my head or neck area.

My cancer is at a stage between T0-T4/N0-N3.

My doctor says I can't have radiation aimed to cure my cancer.

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 radiation therapy (SBRT) or standard radiation therapy (SRT) for advanced head and neck cancer

8 weeks

Multiple visits for radiation sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of local regional failure free survival and patient-reported outcomes

6 years

What Are the Treatments Tested in This Trial?

Interventions

• Standard Radiotherapy (SRT)
• Stereotactic Body Radiotherapy (SBRT)

Trial Overview

The study compares two types of radiation therapy: Standard Radiotherapy (SRT) versus Stereotactic Body Radiotherapy (SBRT). It aims to determine which one provides better control over advanced head and neck cancer.

How Is the Trial Designed?

Group I: Stereotactic Body Radioterapy (SBRT) Experimental Treatment 1 Intervention

Group II: Standard Radiotherapy (SRT) Active Control 1 Intervention

Who Is Running the Clinical Trial?

Canadian Cancer Trials Group

Lead Sponsor

Trials

135

Recruited

70,300+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

Stereotactic body radiotherapy (SBRT) as a boost treatment for head and neck cancer showed a 100% major response rate, with 80.8% of patients achieving complete responses after a median follow-up of 56 months.

Despite its effectiveness in controlling local tumors, 34.6% of patients experienced severe late toxicities, indicating a need for improved dose fractionation and patient selection to minimize complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcome and toxicity of hypofractionated stereotactic body radiotherapy as a boost treatment for head and neck cancer: the importance of boost volume assessment. Lee, DS., Kim, YS., Cheon, JS., et al.[2021]

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 radiation therapy (SBRT) shows promise as a treatment for head and neck cancers, with early results indicating potential benefits.

However, patients with a history of prior external beam radiotherapy may experience serious acute and late side effects, highlighting the need for careful consideration of patient history when using SBRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for head and neck cancer: an addition to the armamentarium against head and neck cancer. Karam, I., Poon, I., Lee, J., et al.[2015]

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) was administered to 66 medically unfit patients with head and neck cancer, showing a 1-year local control rate of 73% and overall survival rate of 64%.

The treatment resulted in only two cases of grade 3 toxicity, indicating that SBRT is a relatively safe option that can effectively manage cancer while preserving the quality of life for patients who cannot undergo conventional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy as primary treatment for elderly and medically inoperable patients with head and neck cancer. Gogineni, E., Rana, Z., Vempati, P., et al.[2021]

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 radiotherapy (SBRT) shows promise in treating head and neck cancer (HNC), particularly in reirradiation settings, but there is currently insufficient evidence to support its use as a primary treatment option.

While SBRT carries risks such as carotid blow out syndrome, alternative treatment regimens may help mitigate these risks, highlighting the need for further research through large Phase III trials to establish its efficacy and safety in HNC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and practical considerations of stereotactic body radiotherapy in the treatment of head and neck cancer. Iqbal, MS., West, N., Richmond, N., et al.[2022]

Stereotactic Body Radiotherapy (SBRT) demonstrated effective local control rates of 78% at one year and 67% at two years for head and neck skin cancer patients, particularly in a high-risk group of 106 medically unfit patients with advanced disease.

The treatment was associated with manageable toxicity, as 31% of patients experienced acute grade 3 or higher side effects, primarily dermatitis, while only 8% had late grade 3 or higher toxicities, indicating that SBRT is a viable option for patients who cannot undergo standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for head and neck skin cancer. Voruganti, IS., Poon, I., Husain, ZA., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8930056/

A multi-institutional analysis of outcomes following ...

We identified 81 patients with 98 lesions treated with SBRT. Areas treated included the lung (53.0%), non-regional lymph nodes (16.0%), and spine (12.3%). OS ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S0360301625029128

Safety and Efficacy of Postoperative Stereotactic Body ...

Adjuvant SBRT demonstrated acceptable toxicity albeit with considerable recurrence rates in patients with newly diagnosed or recurrent HNC. Further research is ...

3.

bmccancer.biomedcentral.com

bmccancer.biomedcentral.com/articles/10.1186/s12885-023-10807-4

A phase 2 study of stereotactic body radiation therapy for ...

This phase 2, single institution, single arm study aims to evaluate response rates to SBRT in older age patients with locally advanced HNSCC.

4.

journals.lww.com

journals.lww.com/amjclinicaloncology/fulltext/2025/10000/research_progress_of_sbrt_combined_with.2.aspx

Research Progress of SBRT Combined With ...

The results showed that the 24-month disease-free survival rate and overall survival rate were 70.4% and 76.4%, respectively. This approach has the potential to ...

5.

frontiersin.org

frontiersin.org/journals/oncology/articles/10.3389/fonc.2019.00836/full

Quality of Life Outcomes Following Organ-Sparing SBRT in ...

Conclusions: OARExtreme-sparing SBRT is able to achieve excellent tumor coverage while protecting the organs at highest risk of re-irradiation- ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10647772/

Survival, Treatment Outcome, and Safety of Multiple and ...

SBRT of HNSCC-derived PMs results in excellent LC rates and encouraging OS rates of 54.9% at two years along with good tolerability (no more ...

7.

redjournal.org

redjournal.org/article/S0360-3016(25)02912-8/fulltext

Safety and Efficacy of Postoperative Stereotactic Body ...

Adjuvant SBRT demonstrated acceptable toxicity albeit with considerable recurrence rates in patients with newly diagnosed or recurrent HNC. Further research is ...

8.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0360301625044864

Fifteen Years of Experience With Stereotactic Body ...

Conclusions. Reirradiation with SBRT is feasible for treating recurrent head and neck cancer. Patient selection is critical for identifying suitable candidates ...

9.

thegreenjournal.com

thegreenjournal.com/article/S0167-8140(23)09336-2/abstract

Stereotactic reirradiation in the treatment of head and neck ...

Median follow-up time was 106.3 months. The 2-year OS rate was 43.8 % (95 % confidence interval, 95 % CI, 34.3–52.9) and the median survival was 20.8 months (95 ...