Recruiting
Phase 3

Stereotactic Boost & Short-course Radiation Therapy

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT04178174

Conditions

Head and Neck Cancer

Oropharynx Cancer

Human Papilloma Virus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SABR boost and de-escalated chemoradiation

Standard chemoradiation

Study Details

Brief summary:

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.

Conditions

Head and Neck Cancer

Oropharynx Cancer

Human Papilloma Virus

Study ID

NCT04178174

Start date

Feb 23, 2020

Status verified date

Jul, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 nerve, brachial plexus, sympathetic trunk or phrenic nerve invasion with dysfunction).
  • 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

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SABR boost and de-escalated chemoradiation

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.

active comparator: Standard chemoradiation

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.

Interventions

SABR boost and de-escalated chemoradiation

Stereotactic body radiotherapy boost to the gross tumor volume to a dose of 14 Gy in 2 fractions, followed by cisplatin-based chemoradiation to a dose of 40 Gy in 20 fractions

Standard chemoradiation

Standard Cisplatin-based chemoradiation to a dose of 70 Gy in 33 fractions

Primary outcome measure

  • Progression free survival [ Time Frame: 2 years after the end of chemoradiation ]

Central Contacts and Locations

Central contacts

Diane Trudel

514-890-8254diane.dt.chum@ssss.gouv.qc.ca

Locations

London Health Sciences Center

Recruiting

London, Ontario, Canada

Contacts

Karen Eddy

(519) 685-8500Karen.Eddy@lhsc.on.ca

Centre Hospitalier de l'Université de Montréal

Recruiting

Montreal, Quebec, Canada, H2X 1R6

Contacts

Mom Phat

514-890-8000mom.phat.chum@ssss.gouv.qc.ca

Principal Investigator:

Houda Bahig

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Aug 24, 2026

Last verified

Jul, 2026

Keywords

  • head and neck cander
  • Oropharynx cancer
  • Human papilloma virus
  • Radiotherapy
  • Stereotactic body radiotherapy
  • Chemotherapy
  • De-intensification

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2026-08-24.