← Back to Search

Radiation Therapy

SABR Boost + Short-course Radiation for Oropharyngeal Cancer (SHORT-OPC Trial)

Phase 2

Recruiting

Led By David Palma, MD PhD

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Clinical stage T1-3, N1 M0 (Stage I-II) as per AJCC 8th edition.

Must not have

Previous irradiation of the head and neck (HNC) region

Prior induction chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 2- and 5-years after the end of chemoradiation

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a shorter, more intense course of radiation therapy is as effective as the standard 7-week course for treating oropharynx cancer associated with the human papillomavirus.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include skin reactions, dry mouth, difficulty swallowing, changes in taste, nausea, fatigue, and possibly low blood counts which could increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

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

Select...

I have been diagnosed with throat cancer through a biopsy.

Select...

My primary tumor is smaller than 30 cc.

Select...

My cancer is HPV positive, confirmed by specific tests.

Select...

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

Select...

I am scheduled for treatment aimed at curing my cancer with both chemotherapy and radiation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had radiation therapy on my head or neck.

Select...

I have received initial chemotherapy.

Select...

I am receiving chemotherapy that does not include Cisplatin.

Select...

I have a connective tissue disease.

Select...

I have had surgery in the head or neck area, excluding minor biopsies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 2- and 5-years after the end of chemoradiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 2- and 5-years after the end of chemoradiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2- and 5-years after the end of chemoradiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Locoregional control

Secondary study objectives

Acute toxicity

Dysphagia

Head and neck symptom burden

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 12Eligibility criteria met