NCT04901234

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
7mo left

Started Jul 2021

Longer than P75 for phase_2

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Jul 2021Dec 2026

First Submitted

Initial submission to the registry

May 17, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

July 30, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

3.3 years

First QC Date

May 17, 2021

Last Update Submit

December 11, 2023

Conditions

Oropharynx CancerRadiotherapy; ComplicationsRadiotherapy Side EffectDysphagiaMRI

Keywords

Oropharynx cancerRadiotherapyAdaptationMagnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • Patient-reported dysphagia

    Patient-reported dysphagia as measured by the MD Anderson Dysphagia Index. Overall score ranges from 0 to 100, with higher score representing better functioning and quality of life.

    at 6 months post treatment

Secondary Outcomes (1)

  • Acute and late toxicities

    From treatment start to 5-years after the end of chemoradiation]

Other Outcomes (5)

  • Locoregional control

    at 6 months, 2 and 5 years

  • Disease-free survival

    at 6 months, 2 and 5 years

  • Overall survival

    at 6 months, 2 and 5 years

  • +2 more other outcomes

Study Arms (2)

Standard radiotherapy

ACTIVE COMPARATOR

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.

Radiation: Standard radiotherapy +/- chemotherapy

Adaptive radiotherapy

EXPERIMENTAL

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

Radiation: Experimental radiotherapy +/- chemotherapy

Interventions

Standard radiotherapy +/- chemotherapyRADIATION

No radiotherapy adaptation unless major dosimetric deviation

Standard radiotherapy
Experimental radiotherapy +/- chemotherapyRADIATION

Systemic MRI-based radiotherapy adaptation mid-treatment

Adaptive radiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Austin Health

Melbourne, Australia

NOT YET RECRUITING

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2x 3E4, Canada

RECRUITING

MeSH Terms

Conditions

Oropharyngeal NeoplasmsRadiation InjuriesDeglutition Disorders

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesWounds and InjuriesEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Phase II open label randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2021

First Posted

May 25, 2021

Study Start

July 30, 2021

Primary Completion

December 1, 2024

Study Completion (Estimated)

December 1, 2026

Last Updated

December 12, 2023

Record last verified: 2023-12

Locations

AU(1)CA(1)