Stereotactic Body Radiation Therapy for Head and Neck Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: M.D. Anderson Cancer Center
Disqualifiers: Pregnant, Lactating, Radiotherapy contraindications
No Placebo Group
Prior Safety Data
Approved in 4 Jurisdictions
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.
12345Is 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.
36789How 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.
1291011Eligibility 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
+4 more
Exclusion Criteria
Pregnant or lactating women
I cannot undergo radiotherapy due to health reasons.
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Traditional PalliationExperimental Treatment1 Intervention
Participant will be randomized to standard radiation
Group II: Stereotactic body radiotherapy (SBRT)Experimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
References
Survey of current practices from the International Stereotactic Body Radiotherapy Consortium (ISBRTC) for head and neck cancers. [2018]To provide a multi-institutional description of current practices of stereotactic body radiotherapy (SBRT) for head and neck cancer.
The role of stereotactic body radiotherapy in reirradiation of head and neck cancer recurrence. [2018]Head and neck cancer recurrence is a therapeutic challenge due to the anatomical and functional constraints of the head and neck area. Stereotactic body radiotherapy (SBRT) is a high-precision technique of radiotherapy that consists of delivering a high ablative biological dose in 1-5 high-dose fractions, requiring a very high precision of the radiotherapy process with potential application in this clinical setting METHODS: Different studies that investigate the role of SBRT in the treatment of recurrent head and neck cancer have been reviewed. Indications to properly select patients for this treatment are presented.
Stereotactic ablative radiosurgery for locally advanced or recurrent skull base malignancies with prior external beam radiation therapy. [2020]Stereotactic ablative radiotherapy (SABR) is an attractive modality to treat malignancies invading the skull base as it can deliver a highly conformal dose with minimal toxicity. However, variation exists in the prescribed dose and fractionation. The purpose of our study is to examine the local control, survival, and toxicities in SABR for the treatment of previously irradiated malignant skull base tumors.
Stereotactic body radiotherapy for recurrent squamous cell carcinoma of the head and neck: results of a phase I dose-escalation trial. [2022]To evaluate the safety and efficacy of stereotactic body radiotherapy (SBRT) in previously irradiated patients with squamous cell carcinoma of the head and neck (SCCHN).
Stereotactic ablative body radiosurgery (SABR) or Stereotactic body radiation therapy (SBRT). [2022]While conventional treatment relies on protracted courses of therapy using relatively small dose-per-fraction sizes of 1.8-2Gy, there is substantial evidence gathered over decades that this may not be the optimal approach for all targetable disease. Stereotactic ablative body radiosurgery (SABR) or stereotactic body radiation therapy (SBRT) is a technique which uses precise targeting to deliver high doses of radiation capable of ablating tumors directly. In this review, we will discuss the justification for and techniques used to deliver ablative doses to improve treatment outcomes, interactions with biological and immunologic therapy, and special procedures to spare normal tissue, which have facilitated the expanding role for these techniques in the management of a wide range of malignant histologies and disease states.
Serious complications associated with stereotactic ablative radiotherapy and strategies to mitigate the risk. [2018]The clinical applications of stereotactic body radiotherapy or stereotactic ablative radiotherapy (SABR) for the treatment of primary and metastatic tumours of different organ sites have been expanding rapidly in the recent decade. SABR requires advanced technology in radiotherapy planning and image guidance to deliver a highly conformal ablative dose precisely to targets (or tumours) in the body. Although this treatment modality has shown promising results with regard to tumour control, some serious complications have been observed and reported. In order to achieve a favourable therapeutic ratio, strategies to mitigate the risk of complications must be in place. This overview will summarise the reported serious complications caused by SABR and strategies to mitigate the risk will be discussed.
A retrospective study on unresectable or inoperable head and neck cancers treated with stereotactic ablative brachytherapy. [2023]The aim of the present study was to assess the clinical efficacy and safety of stereotactic ablative brachytherapy (SABT) for unresectable or inoperable head and neck cancers.
Technical know-how in stereotactic ablative radiotherapy (SABR). [2022]Stereotactic ablative radiotherapy (SABR) is an addition to the armamentarium against cancer. The technical requirements for SABR are very stringent, given its very narrow therapeutic window. However, when the principles are strictly followed, it is possible to deliver SABR to extracranial tumours safely and effectively.
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]The aim of this study was to assess the safety and outcome of stereotactic body radiotherapy (SBRT) in patients with recurrent previously irradiated squamous cell carcinoma of the head and neck (rSCCHN).
Stereotactic Body Radiotherapy (SBRT) for primary and recurrent head and neck tumors. [2015]Stereotactic Body Radiotherapy (SBRT) is increasingly used to treat a variety of head and neck tumors as a result of its highly conformal dose distributions and stereotactic spatial accuracy in delivery. Our experience and other previous reports have shown that SBRT is technically feasible, well-tolerated and compares favorably to other alternatives of salvage therapy in the management of patients with recurrent and/or previously irradiated head and neck cancers. Furthermore, it has the advantage of a shorter treatment schedule, greater compliance, and safe delivery in the outpatient setting. This affords an opportunity to introduce SBRT as a definitive treatment in select patients. This review presents an overview of the use of SBRT for managing head and neck tumors by highlighting the existing indications and the expanding role of SBRT in managing these patients.
Prospective evaluation of patient-reported quality-of-life outcomes following SBRT ± cetuximab for locally-recurrent, previously-irradiated head and neck cancer. [2019]Stereotactic body radiotherapy (SBRT) has emerged as a promising salvage strategy for unresectable, previously-irradiated recurrent squamous cell carcinomas of the head and neck (rSCCHN). Here-in, we report the first prospective evaluation of patient-reported quality-of-life (PR-QoL) following re-irradiation with SBRT±cetuximab for rSCCHN.