Recruiting
Phase 2

Adaptive RadioTherapy

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT04901234

Conditions

Oropharynx Cancer

Radiotherapy; Complications

Radiotherapy Side Effect

Dysphagia

MRI

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard radiotherapy +/- chemotherapy

Experimental radiotherapy +/- chemotherapy

Study Details

Brief summary:

This is a phase II randomized trial, where patients with histologically proven squamous cell carcinoma of oropharynx that have primary tumor (T3 - T4) in place, treated with curative intent chemoradiation, will be randomized to systematic mid-treatment MRI-based radiotherapy adaptation vs. standard of care. The primary objective is to compare patient-rated dysphagia (as assessed by the MD Anderson Dysphagia Inventory composite score at 6 months post-treatment in patients undergoing routine mid-treatment MR-guided radiotherapy adaptation vs. in patients receiving the current standard of care.

Conditions

Oropharynx Cancer

Radiotherapy; Complications

Radiotherapy Side Effect

Dysphagia

MRI

Study ID

NCT04901234

Start date

Jul 30, 2021

Status verified date

Aug, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥18 years
  • Ability to provide written informed consent.
  • Stage T3-T4N0-3 as per AJCC 8th edition
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Biopsy proven diagnosis of squamous cell carcinoma of the oropharynx.
  • Planned for curative radiotherapy +/- chemotherapy
  • For females of child-bearing age, a negative pregnancy test
  • Patients treated with induction chemotherapy can be included if they have residual tumor in place.

Exclusion Criteria:

  • Previous irradiation of the head and neck (HNC) region, excluding superficial radiation therapy for non-melanomatous skin cancer
  • 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.
  • Patients with contra-indications to MRI will be excluded.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard radiotherapy

Radiotherapy as planned at baseline, with replanning allowed only if significant weight loss or change in anatomy due to unforeseen circumstances (eg that would affect dosimetry and treatment delivery of baseline treatment plan). No adaptation to shrinking tumour is allowed.

experimental: Adaptive radiotherapy

Systematic radiation treatment plan adaptation according to the shrinking tumour on mid-treatment MRI.

Interventions

Standard radiotherapy +/- chemotherapy

No radiotherapy adaptation unless major dosimetric deviation

Experimental radiotherapy +/- chemotherapy

Systemic MRI-based radiotherapy adaptation mid-treatment

Primary outcome measure

  • Patient-reported dysphagia [ Time Frame: at 6 months post treatment ]

Central Contacts and Locations

Locations

Centre Hospitalier de l'Université de Montréal

Recruiting

Montreal, Quebec, Canada, H2x 3E4

Contacts

Mom Phat

514-890-8254mom.phat.chum@ssss.gouv.qc.ca

Silvine Benth

514-890-8254mom.phat.chum@ssss.gouv.qc.ca

Principal Investigator:

Edith Filion, MD

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • Oropharynx cancer
  • Radiotherapy
  • Adaptation
  • Magnetic resonance imaging

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.