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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.

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

SHORT-OPC Trial 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.Check my eligibility

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.See study design

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.

SHORT-OPC Trial Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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

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I have been diagnosed with throat cancer through a biopsy.

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My primary tumor is smaller than 30 cc.

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My cancer is HPV positive, confirmed by specific tests.

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

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

SHORT-OPC Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Locoregional control

Secondary outcome measures

Acute toxicity

Dysphagia

Head and neck symptom burden

+5 more

SHORT-OPC 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 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

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

368 Previous Clinical Trials

129,651 Total Patients Enrolled

M.D. Anderson Cancer CenterOTHER

2,977 Previous Clinical Trials

1,789,442 Total Patients Enrolled

Lawson Health Research InstituteOTHER

661 Previous Clinical Trials

413,816 Total Patients Enrolled

Media Library

SABR boost and de-escalated chemoradiation (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04178174 — Phase 2

Head and Neck Cancers Clinical Trial 2023: SABR boost and de-escalated chemoradiation Highlights & Side Effects. Trial Name: NCT04178174 — Phase 2

Head and Neck Cancers Research Study Groups: SABR boost and de-escalated chemoradiation, Standard chemoradiation

SABR boost and de-escalated chemoradiation (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04178174 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks are associated with SABR boost and de-escalated chemoradiation?

"SABR boost and de-escalated chemoradiation was given a safety score of 2. This is due to the lack of efficacy data, as this is only a Phase 2 trial."

Answered by AI

How many people are being recruited for this research project?

"That is correct, according to the clinicaltrials.gov website, this study is currently looking for participants. The trial was first posted on February 23rd 2020 and was last edited on April 24th 2022. They are hoping to enroll 106 patients at a single site."

Answered by AI

Are volunteers being accepted for this experiment currently?

"The most recent update on clinicaltrials.gov suggests that this trial is still looking for participants. The posting date was February 23rd, 2020 and the April 24th, 2022 update confirms that recruitment is ongoing."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Stereotactic Boost and Short-course Radiation Therapy for Oropharynx Cancer

Houda Bahig 2020. "Stereotactic Boost and Short-course Radiation Therapy for Oropharynx Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04178174.

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