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Adaptive RadioTherapy for OroPharynx Cancer

ConditionsOropharynx CancerRadiotherapy; ComplicationsRadiotherapy Side EffectDysphagiaMRI
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard radiotherapy +/- chemotherapy

    Radiation

    No radiotherapy adaptation unless major dosimetric deviation

  • Experimental radiotherapy +/- chemotherapy

    Radiation

    Systemic MRI-based radiotherapy adaptation mid-treatment

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Standard radiotherapyActive comparator 1 intervention
Group B: Adaptive radiotherapyExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
at 6 months post treatment

Secondary outcomes

1

Acute and late toxicities

Rate of grade ≥ 3 late toxicity as per CTCAE v5.0

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

Other outcomes

1

Locoregional control

Time frame
at 6 months, 2 and 5 years
2

Disease-free survival

Time frame
at 6 months, 2 and 5 years
3

Overall survival

Time frame
at 6 months, 2 and 5 years
4

Complete response rate

Time frame
at 6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre hospitalier de l'Université de Montréal (CHUM)

Lead sponsor

Austin Health

Collaborator

Source ClinicalTrials.gov
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