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Adaptive RadioTherapy for OroPharynx Cancer

NCT04901234 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-12-12

No results posted yet for this study

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

Interventions

RADIATION

Standard radiotherapy +/- chemotherapy

No radiotherapy adaptation unless major dosimetric deviation

RADIATION

Experimental radiotherapy +/- chemotherapy

Systemic MRI-based radiotherapy adaptation mid-treatment

Sponsors & Collaborators

  • Austin Health

    collaborator OTHER_GOV

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-30
Primary Completion
2024-12-31
Completion
2026-12-31

Countries

  • Australia
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04901234 on ClinicalTrials.gov