Stereotactic vs Standard Radiotherapy for Head and Neck Cancer

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

Trial Summary

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.

What data supports the effectiveness of the treatment Stereotactic Body Radiotherapy (SBRT) for head and neck cancer?

Research shows that using Stereotactic Body Radiotherapy (SBRT) as a boost treatment after conventional radiotherapy can improve local control and overall survival rates in head and neck cancer patients, with a median local control rate of 92% and overall survival rate of 80% at 3 years. However, there are risks of severe late toxicities, so it should be used cautiously. ^{1 2 3 4 5}

Is stereotactic body radiotherapy (SBRT) safe for treating head and neck cancer?

Stereotactic body radiotherapy (SBRT) is generally considered safe for treating head and neck cancer, but serious side effects have been observed, especially in patients who have had previous radiation treatments. It is well-tolerated and can be safely delivered in an outpatient setting, offering a shorter treatment schedule and good patient compliance. ^{1 6 7 8 9}

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

Stereotactic Body Radiotherapy (SBRT) is unique because it delivers highly precise radiation doses to tumors, allowing for shorter treatment schedules and potentially fewer side effects compared to traditional methods like surgery or chemoradiation. This makes it a promising option for patients who cannot undergo surgery or have previously received radiation. ^{1 2 9 10 11}

What is the purpose of this trial?

This study is being done to answer the following question: Does stereotactic body radiation therapy (SBRT) provide better cancer control compared to standard radiation therapy (RT) for those with advanced head and neck cancer?

Research Team

Ian Poon

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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) 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) 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 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 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 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]

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

Stereotactic body radiotherapy as primary treatment for elderly and medically inoperable patients with head and neck cancer. [2021]

3. England 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. [2021]

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

The impact of tumor volume and radiotherapy dose on outcome in previously irradiated recurrent squamous cell carcinoma of the head and neck treated with stereotactic body radiation therapy. [2022]

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

Stereotactic radiotherapy as planned boost after definitive radiotherapy for head and neck cancers: Systematic review. [2022]

6. 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]

7. 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]

8. England pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for head and neck cancer: an addition to the armamentarium against head and neck cancer. [2015]

9. England pubmed.ncbi.nlm.nih.gov

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

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

A systematic review and practical considerations of stereotactic body radiotherapy in the treatment of head and neck cancer. [2022]

11. Ireland pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for head and neck skin cancer. [2022]