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Clinical Trial NCT04901234 (ART-OPC) for Oropharynx Cancer, Radiotherapy; Complications, Radiotherapy Side Effect, Dysphagia, MRI is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Adaptive RadioTherapy for OroPharynx Cancer (ART-OPC) Phase 2 120 Randomized Adaptive Design

Recruiting
Clinical Trial NCT04901234 (ART-OPC) is designed to study Treatment for Oropharynx Cancer, Radiotherapy; Complications, Radiotherapy Side Effect, Dysphagia, MRI. It is a Phase 2 interventional study that is recruiting, having started on July 30, 2021, with plans to enroll 120 participants. Led by Centre hospitalier de l'Université de Montréal (CHUM), it is expected to complete by December 1, 2026. The latest data from ClinicalTrials.gov was last updated on December 12, 2023.
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...Show More
Detailed Description
Background: Dysphagia was shown to be the main driver of adverse quality of life after head and neck radiotherapy. Over the 7-week radiotherapy course, patients with head and neck cancers undergo significant anatomical changes, including weight loss and tumor shrinkage (with complete response at mid-treatment in as high as 50% of patients). The current standard of care is to maintain the same radiotherapy plan for th...Show More
Official Title

Adaptive RadioTherapy for Locally Advanced OroPharynx Cancer (ART-OPC) A Phase II Randomized Trial

Conditions
Oropharynx CancerRadiotherapy; ComplicationsRadiotherapy Side EffectDysphagiaMRI
Other Study IDs
  • ART-OPC
NCT ID Number
NCT04901234
Start Date (Actual)
2021-07-30
Last Update Posted
2023-12-12
Completion Date (Estimated)
2026-12
Enrollment (Estimated)
120
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
Oropharynx cancer
Radiotherapy
Adaptation
Magnetic resonance imaging
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorStandard 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.
Standard radiotherapy +/- chemotherapy
No radiotherapy adaptation unless major dosimetric deviation
ExperimentalAdaptive radiotherapy
Systematic radiation treatment plan adaptation according to the shrinking tumour on mid-treatment MRI.
Experimental radiotherapy +/- chemotherapy
Systemic MRI-based radiotherapy adaptation mid-treatment
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Acute and late toxicities
Rate of grade ≥ 3 late toxicity as per CTCAE v5.0
From treatment start to 5-years after the end of chemoradiation]
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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.

  • 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.
Centre hospitalier de l'Université de Montréal (CHUM) logoCentre hospitalier de l'Université de Montréal (CHUM)
Austin Health logoAustin Health
No contact data.
2 Study Locations in 2 Countries

Quebec

Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, H2x 3E4, Canada
Mom Phat, Contact, 514-890-8254, [email protected]
Silvine Benth, Contact, 514-890-8254, [email protected]
Edith Filion, MD, Principal Investigator
Houda Bahig, MD PhD, Sub-Investigator
Recruiting
Austin Health, Melbourne, Australia
Sweet Ping Ng, MD PhD, Contact
Sweet Ping Ng, MD PhD, Principal Investigator
Not yet recruiting