Stereotactic Ablative Radiotherapy for Head and Neck Cancer

(SUPPRESS Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: Pregnancy, Breastfeeding, Spinal cord compression, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

A registry-based randomized phase II trial. A total of 46 patients with metastatic head and neck cancer on systemic therapy with oligoprogression to 1-5 extracranial lesions will be randomized using a 1:1 ratio to standard of care (begin next-line systemic therapy, best supportive care, continue current systemic line, based on treating physician decision) vs. receive stereotactic ablative radiotherapy to all oligoprogressive lesions while continuing their current systemic therapy.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. In fact, it specifies that participants will continue their current systemic therapy while receiving the new treatment.

What data supports the effectiveness of the treatment Stereotactic Ablative Radiotherapy for Head and Neck Cancer?

Research suggests that Stereotactic Body Radiotherapy (SBRT) can effectively control head and neck cancer while limiting side effects, especially in patients who cannot undergo surgery or traditional radiation. It has shown promise in improving quality of life and managing symptoms in patients with advanced or inoperable head and neck cancers. ^{1 2 3 4 5}

Is stereotactic ablative radiotherapy safe for head and neck cancer?

Research shows that stereotactic ablative radiotherapy, also known as stereotactic body radiotherapy (SBRT) or radiosurgery, has been studied for safety in treating head and neck cancers. Studies indicate it is generally safe, even for patients who have had previous radiation treatments, although specific side effects can vary. ^{1 6 7 8 9}

How is the treatment Stereotactic Ablative Radiotherapy for head and neck cancer different from other treatments?

Stereotactic Ablative Radiotherapy (also known as Stereotactic Body Radiotherapy or SBRT) is unique because it delivers highly precise radiation doses to head and neck tumors, allowing for a shorter treatment schedule and greater patient compliance compared to traditional therapies. It is particularly beneficial for patients with recurrent or previously irradiated cancers, offering a technically feasible and well-tolerated option in an outpatient setting. ^{1 2 10 11 12}

Research Team

Eligibility Criteria

Adults over 18 with metastatic head and neck cancer who've seen their disease progress on current systemic treatments. They must have a decent performance status, meaning they can carry out daily activities with varying degrees of assistance. The trial is for those with limited progression in up to 5 lesions that are less than 5cm and spread across no more than 3 organs.

Inclusion Criteria

Ability to provide written informed consent

My cancer has spread to 1-5 spots outside the brain, affecting up to 3 organs, and is under 5cm.

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

Exclusion Criteria

Pregnancy or breastfeeding

I have spinal cord compression.

My cancer has spread to my digestive system.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either standard of care or receive stereotactic ablative radiotherapy to oligoprogressive lesions while continuing current systemic therapy

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Treatment Details

Interventions

• Experimental arm (Radiation)
• Standard arm (Other)

Trial Overview This phase II trial tests if using Stereotactic Ablative Radiotherapy (SABR) on up to five small progressing cancer spots while continuing current systemic therapy is better compared to just switching therapies or supportive care as decided by the doctor.

Participant Groups

Group I: Experimental SABR arm Experimental Treatment 1 Intervention

Definitive SABR to oligoprogressive lesions + continue current systemic therapy

Group II: Standard of care Active Control 1 Intervention

Switch to subsequent systemic therapy line, best supportive care or continue current systemic line

Experimental arm is already approved in Canada for the following indications:

Approved in Canada as Stereotactic Body Radiotherapy (SBRT) for:

• Similar to those in the US and EU, specific indications may vary by province

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Dr. Réjean Lapointe

Centre hospitalier de l'Université de Montréal (CHUM)

Chief Medical Officer since 2023

MD from Université de Montréal

Dr. Fabrice Brunet

Centre hospitalier de l'Université de Montréal (CHUM)

Chief Executive Officer since 2015

MD from Université de Montréal

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) 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]

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) demonstrated significant efficacy in treating head and neck tumors, with a local control rate of 94% for de novo tumors at 3 months, indicating it is a viable option for patients not suitable for surgery.

Patients reported improved quality of life after treatment, with pre-treatment scores showing a trend towards significance (p=0.05), suggesting that SBRT not only controls tumor growth but also enhances the well-being of elderly and frail patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of stereotactic body radiotherapy for symptom control in head and neck cancer patients. Khan, L., Tjong, M., Raziee, H., et al.[2022]

The combination of stereotactic body radiation therapy (SBRT) with the anti-PD-1 drug nivolumab was found to be safe and did not delay surgery in 21 patients with advanced head and neck cancer, meeting the primary safety endpoint of the study.

This treatment approach resulted in a high major pathological response (mPR) rate of 86% and a pathological complete response (pCR) rate of 67%, indicating that adding SBRT may enhance the effectiveness of immunotherapy in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neoadjuvant immunoradiotherapy results in high rate of complete pathological response and clinical to pathological downstaging in locally advanced head and neck squamous cell carcinoma. Leidner, R., Crittenden, M., Young, K., et al.[2022]

Stereotactic body radiation therapy (SBRT) demonstrated a 77% overall response rate in treating head-and-neck cancers, with significant tumor volume reduction observed in patients, indicating its efficacy as a treatment option.

The treatment showed promising tumor control rates of 83.3% for primary tumors and 60.6% for recurrent tumors, with median overall survival times of 28.7 months for primary, 6.7 months for recurrent, and 5.6 months for metastatic cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for primary, recurrent, and metastatic tumors in the head-and-neck region. Siddiqui, F., Patel, M., Khan, M., et al.[2009]

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]

Single fraction stereotactic radiosurgery (SRS) demonstrated a one-year local control rate of 52.7% in 18 patients with recurrent head and neck cancers, suggesting it can be an effective treatment option for these challenging cases.

The median overall survival for patients treated with SRS was 25.4 months, although those with parotid gland tumors and squamous cell histology faced higher risks of disease progression and lower survival rates, indicating the need for careful patient selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single Fraction Stereotactic Radiosurgery for Retreatment of Skull Base Recurrent Head and Neck Malignancies. Patel, RA., Lock, D., Kim, T., 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 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 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 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]

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. Ireland pubmed.ncbi.nlm.nih.gov

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

3. 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]

4. Germany pubmed.ncbi.nlm.nih.gov

Role of stereotactic body radiotherapy for symptom control in head and neck cancer patients. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Neoadjuvant immunoradiotherapy results in high rate of complete pathological response and clinical to pathological downstaging in locally advanced head and neck squamous cell carcinoma. [2022]

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

Stereotactic body radiation therapy for primary, recurrent, and metastatic tumors in the head-and-neck region. [2009]

7. 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]

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

Single Fraction Stereotactic Radiosurgery for Retreatment of Skull Base Recurrent Head and Neck Malignancies. [2020]

9. 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]

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

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

11. 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]

12. 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]