SABR Boost + Short-course Radiation for Oropharyngeal Cancer
(SHORT-OPC Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
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)
Must not be taking: Non-Cisplatin chemotherapy
Disqualifiers: Previous head/neck irradiation, Pregnancy, Connective tissue disease, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This is a randomized clinical trial comparing the outcomes of short-course chemoradiation consisting in stereotactic boost to the gross tumor and de-esclalated chemoradiation to the elective neck in human papilloma associated oropharynx cancer vs. the current standard 7-week course chemoradiation.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it does mention that participants cannot have had prior induction chemotherapy or non-Cisplatin concurrent chemotherapy.
What data supports the effectiveness of the treatment SABR Boost + Short-course Radiation for Oropharyngeal Cancer?
Research shows that using stereotactic body radiotherapy (SBRT) as a boost treatment for head and neck cancer, including oropharyngeal cancer, can be effective in improving outcomes. Studies have reported positive long-term results and suggest that this approach may help reduce local recurrence of the cancer.
12345Is SABR Boost + Short-course Radiation generally safe for humans?
Stereotactic Body Radiotherapy (SBRT) has been used safely in humans, but it can cause side effects like tissue damage and difficulty swallowing. In a study with oropharyngeal cancer patients, some experienced serious side effects, including tissue damage and bone problems, especially if they smoked or had other health issues.
13678How is the SABR Boost + Short-course Radiation treatment for oropharyngeal cancer different from other treatments?
The SABR Boost + Short-course Radiation treatment is unique because it uses a precise form of radiation called stereotactic body radiotherapy (SBRT) to deliver high doses of radiation in fewer sessions, which can be beneficial for patients who are not suitable for traditional brachytherapy (a type of internal radiation). This approach aims to intensify the treatment of the primary tumor while potentially reducing the overall treatment time and side effects.
12345Eligibility Criteria
This trial is for adults over 18 with HPV-positive oropharyngeal cancer, who haven't had major head and neck surgery or radiation before. They should be in good enough health to follow the trial procedures and not pregnant. The cancer must be at an early stage (Stage I-II) and the primary tumor smaller than 30 cc.Inclusion Criteria
Ability to provide written informed consent.
I am of child-bearing age and my pregnancy test is negative.
I am 18 years old or older.
+6 more
Exclusion Criteria
I have had radiation therapy on my head or neck.
I have received initial chemotherapy.
You are pregnant or currently breastfeeding.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either SABR boost and de-escalated chemoradiation or standard chemoradiation
7 weeks
Daily visits for radiation therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
5 years
Regular visits at 1, 3, 6, 12 months, and yearly from years 2-5
Participant Groups
The study compares a shorter course of chemoradiation with a stereotactic boost directly to the tumor against the standard longer seven-week chemoradiation treatment for HPV-associated oropharynx cancer.
2Treatment groups
Experimental Treatment
Active Control
Group I: SABR boost and de-escalated chemoradiationExperimental Treatment1 Intervention
SABR boost of 14 Gy in 2 fractions to the GTV, immediately followed by de-escalated chemoradiation. De-escalated chemoradiation will consist in 40 Gy in 20 fractions with concurrent high dose Cisplatin (3-weekly, 100 mg/m2) for 2 cycles, aiming for a cumulative dose of 200 mg/m2.
Group II: Standard chemoradiationActive Control1 Intervention
The standard arm will consist of conventionally radiation to a dose of 70 Gy in 33 fractions concurrently with high dose Cisplatin (3-weekly, 100 mg/m2) for 2-3 cycles, aiming for a cumulative dose of ≥ 200 mg/m2.
SABR boost and de-escalated chemoradiation is already approved in United States, Canada, European Union for the following indications:
🇺🇸 Approved in United States as SABR for:
- Non-small cell lung cancer (NSCLC)
- Oligometastatic disease
- Recurrent head and neck cancer
🇨🇦 Approved in Canada as SABR for:
- Oligometastatic disease
- Recurrent head and neck cancer
🇪🇺 Approved in European Union as SABR for:
- Non-small cell lung cancer (NSCLC)
- Oligometastatic disease
- Recurrent head and neck cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
London Health Sciences CenterLondon, Canada
Centre Hospitalier de l'Université de MontréalMontreal, Canada
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Who Is Running the Clinical Trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph'sCollaborator
London Health Sciences Centre OR Lawson Research Institute of St. Joseph'sCollaborator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sCollaborator
M.D. Anderson Cancer CenterCollaborator
Lawson Health Research InstituteCollaborator
Jewish General HospitalCollaborator
References
Stereotactic body radiotherapy: a promising treatment option for the boost of oropharyngeal cancers not suitable for brachytherapy: a single-institutional experience. [2012]To prospectively assess the outcome and toxicity of frameless stereotactic body radiotherapy (SBRT) as a treatment option for boosting primary oropharyngeal cancers (OPC) in patients who not suitable for the standard brachytherapy boost (BTB).
Hypofractionated stereotactic radiotherapy using CyberKnife as a boost treatment for head and neck cancer, a multi-institutional survey: impact of planning target volume. [2018]To evaluate the role of hypofractionated stereotactic radiotherapy (hSRT) as a boost treatment for head and neck cancer.
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]The aim of this study was to report the long-term clinical outcomes of patients who received stereotactic body radiotherapy (SBRT) as a boost treatment for head and neck cancer.
Dose escalation in oropharyngeal cancer: a comparison of simultaneous integrated boost and brachytherapy boost. [2023]Local recurrence is the most common pattern of failure in head and neck cancer. It can therefore be hypothesised that some of these patients would benefit from an intensified local treatment, such as radiation dose escalation of the primary tumour. This study compares treatment and toxicity outcomes from two different boost modalities in oropharyngeal cancer: simultaneous integrated boost (SIB) and brachytherapy boost.
Locoregional failures and their relation to radiation fields following stereotactic body radiotherapy boost for oropharyngeal squamous cell carcinoma. [2020]To investigate the location of recurrences with respect to the radiation fields in oropharynx cancer after intensity-modulated radiotherapy and stereotactic body radiotherapy (SBRT) boost.
Long-term outcomes following stereotactic body radiotherapy boost for oropharyngeal squamous cell carcinoma. [2019]Background/purpose: To determine the efficacy and toxicity profile of a stereotactic body radiotherapy (SBRT) boost as a first line treatment in patients with oropharyngeal squamous cell carcinoma (OPSCC). Materials and methods: We performed a retrospective cohort study in 195 consecutive OPSCC patients with T1-small T3 disease, treated at Erasmus MC between 2009 and 2016 with a SBRT (3 × 5.5 Gy) boost after 46 Gy IMRT. Primary endpoints were disease-specific survival (DSS) and Grade ≥3 toxicity (Common Terminology Criteria). The Kaplan-Meier method and Cox regression model were applied to determine rates and risk factors. Results: The median follow-up was 4.3 years. Treatment compliance was high (100%). Rates of 5-year DSS and late grade ≥3 toxicity were 85% and 28%, respectively. Five-year overall survival was 67%. The most frequently observed toxicities were mucosal ulceration or soft tissue necrosis (n = 30, 5 year 18%), dysphagia or weight loss (n = 18, 5 year 12%) and osteoradionecrosis (n = 11, 5 year 9%). Current smoker status (hazard ratio [HR] = 2.9, p = .001) and Charlson Comorbidity Index ≥2 (HR = 1.9, p = .03) were was associated with increased toxicity risk. Tooth extraction prior to RT was associated with increased osteoradionecrosis risk (HR = 6.4, p = .006). Conclusion: We reported on outcomes in the largest patient series to date treated with a hypofractionated boost for OPSCC. Efficacy was good with survival rates comparable to conventionally fractionated (chemo)radiotherapy. Grade ≥3 toxicity profiles showed high rates of soft tissue necrosis and osteoradionecrosis. Strategies to mitigate severe toxicity risks are under investigation to improve the tolerability of the SBRT boost.
UK Consensus on Normal Tissue Dose Constraints for Stereotactic Radiotherapy. [2022]Six UK studies investigating stereotactic ablative radiotherapy (SABR) are currently open. Many of these involve the treatment of oligometastatic disease at different locations in the body. Members of all the trial management groups collaborated to generate a consensus document on appropriate organ at risk dose constraints. Values from existing but older reviews were updated using data from current studies. It is hoped that this unified approach will facilitate standardised implementation of SABR across the UK and will allow meaningful toxicity comparisons between SABR studies and internationally.
Stereotactic ablative radiotherapy (SABR) for recurrent and previously irradiated head and neck cancers. [2022]To assess the response and toxicity of stereotactic ablative radiotherapy (SABR) in patients with recurrent head and neck cancer (HNC), who had previously received radiation for their primary tumor.