Recruiting at 2 sites Phase 3 Head and Neck Cancer

Head and Neck Cancer study: Standard chemoradiation

Official title Stereotactic Boost and Short-course Radiation Therapy for Oropharynx Cancer

ClinicalTrials.gov ID: NCT04178174

What this study is testing

What it's testing
The study compares whether a shorter, more targeted radiation treatment gives similar results to the standard 7‑week course.
Who it's for
Adults with HPV‑related cancer of the oropharynx (part of the throat).
What's involved
Participants receive either the short‑course treatment with a focused boost to the tumor and reduced radiation to the neck, or the standard 7‑week treatment. They will have regular visits and tests to monitor progress.
Time commitment
The study lasts about 7 weeks of treatment, with follow‑up visits afterward to check outcomes.
  • Phase 3: a large, late-stage study
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Age ≥18 years
  • Ability to provide written informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Biopsy proven diagnosis of squamous cell carcinoma of the oropharynx.
  • Positive for HPV by p16 immunohistochemistry (IHC) or HPV in-situ hybridization (ISH)

You likely can't join if

  • Clinical N3 classification, as per AJCC 8th edition
  • Clinically overt extranodal extension (ENE). As per AJCC 8th edition, clinically overt ENE is defined as invasion of the skin, infiltration of...
  • Previous irradiation of the head and neck region
  • Previous surgery of the HNC region (except for incisional or excisional biopsies)
  • Pregnancy or breastfeeding
  • Connective tissue disease
See the full eligibility criteria
Who can join
  • Age ≥18 years
  • Ability to provide written informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Biopsy proven diagnosis of squamous cell carcinoma of the oropharynx.
  • Positive for HPV by p16 immunohistochemistry (IHC) or HPV in-situ hybridization (ISH)
  • Clinical stage T1-3, N1 M0 (Stage I-II) as per AJCC 8th edition.
  • Primary tumor \< 30 cc
  • Planned for curative chemoradiation
  • For females of child-bearing age, a negative pregnancy test
What rules you out
  • Clinical N3 classification, as per AJCC 8th edition
  • Clinically overt extranodal extension (ENE). As per AJCC 8th edition, clinically overt ENE is defined as invasion of the skin, infiltration of musculature/fixation to adjacent structures on clinical examination, cranial...
  • Previous irradiation of the head and neck region
  • Previous surgery of the HNC region (except for incisional or excisional biopsies)
  • Pregnancy or breastfeeding
  • Connective tissue disease
  • Any medical condition that could, in the opinion of the investigator, prevent follow-up after radiotherapy.
  • Non-Cisplatin concurrent chemotherapy
  • Prior induction chemotherapy

The study team makes the final eligibility decision.

Where it is enrolling

  • London, Ontario, Canada
  • Montreal, Quebec, Canada

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at London, Ontario, Canada; Montreal, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.