360 Participants Needed

SABR Boost + Short-course Radiation for Oropharyngeal Cancer

(SHORT-OPC Trial)

Recruiting at 1 trial location
DT
Overseen ByDiane Trudel
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Is 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.12345

How 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.24678

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.24678

Who Is on the Research Team?

Jewish General Hospital | Khalil Sultanem

Khalil Sultanem, MD

Principal Investigator

Montreal Jewish General Hospital

JP

Jack Phan, MD,PHD

Principal Investigator

M.D. Anderson Cancer Center

HB

Houda Bahig, MD PhD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

PN

Phuc-Felix Nguyen-Tan, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

DP

David Palma, MD PhD

Principal Investigator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Are You a Good Fit for This Trial?

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.
My breast cancer is in an early to mid-stage, but has spread to nearby lymph nodes.
See 5 more

Exclusion Criteria

I have had radiation therapy on my head or neck.
I have received initial chemotherapy.
You are pregnant or currently breastfeeding.
See 4 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • SABR boost and de-escalated chemoradiation
  • Standard chemoradiation
Trial Overview 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.
How Is the Trial Designed?
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

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials
389
Recruited
143,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Collaborator

Trials
686
Recruited
427,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Collaborator

Trials
668
Recruited
424,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Collaborator

Trials
678
Recruited
421,000+

M.D. Anderson Cancer Center

Collaborator

Trials
3,107
Recruited
1,813,000+

Lawson Health Research Institute

Collaborator

Trials
684
Recruited
432,000+

Jewish General Hospital

Collaborator

Trials
144
Recruited
283,000+

Published Research Related to This Trial

Frameless stereotactic body radiotherapy (SBRT) was found to be a safe and effective treatment option for boosting primary oropharyngeal cancers in 51 patients who were not suitable for standard brachytherapy, achieving 2-year local control, disease-free survival, and overall survival rates of 86%, 80%, and 82%, respectively.
The treatment was well tolerated with no severe (Grade 4 or 5) toxicities reported, and only 28% of patients experienced Grade 2 or higher late toxicity, indicating that SBRT can be a viable alternative with minimal adverse effects.
Stereotactic body radiotherapy: a promising treatment option for the boost of oropharyngeal cancers not suitable for brachytherapy: a single-institutional experience.Al-Mamgani, A., Tans, L., Teguh, DN., et al.[2012]
In a study of 25 head and neck cancer patients treated with hypofractionated stereotactic radiotherapy (hSRT) using CyberKnife, there was a high response rate of 96%, with 18 patients achieving complete responses and 6 partial responses after a median follow-up of 28 months.
The study found that smaller planning target volumes (PTV ≤ 20 cm³) were associated with significantly better progression-free survival (92%) and overall survival (100%) compared to larger volumes, indicating that both the size of the treatment area and initial response to treatment are important predictors of patient outcomes.
Hypofractionated stereotactic radiotherapy using CyberKnife as a boost treatment for head and neck cancer, a multi-institutional survey: impact of planning target volume.Yamazaki, H., Ogita, M., Himei, K., et al.[2018]
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.
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]

Citations

Stereotactic body radiotherapy: a promising treatment option for the boost of oropharyngeal cancers not suitable for brachytherapy: a single-institutional experience. [2012]
Hypofractionated stereotactic radiotherapy using CyberKnife as a boost treatment for head and neck cancer, a multi-institutional survey: impact of planning target volume. [2018]
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]
Dose escalation in oropharyngeal cancer: a comparison of simultaneous integrated boost and brachytherapy boost. [2023]
Locoregional failures and their relation to radiation fields following stereotactic body radiotherapy boost for oropharyngeal squamous cell carcinoma. [2020]
Long-term outcomes following stereotactic body radiotherapy boost for oropharyngeal squamous cell carcinoma. [2019]
UK Consensus on Normal Tissue Dose Constraints for Stereotactic Radiotherapy. [2022]
Stereotactic ablative radiotherapy (SABR) for recurrent and previously irradiated head and neck cancers. [2022]
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