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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04901234




Registration number
NCT04901234
Ethics application status
Date submitted
17/05/2021
Date registered
25/05/2021
Date last updated
12/12/2023

Titles & IDs
Public title
Adaptive RadioTherapy for OroPharynx Cancer
Scientific title
Adaptive RadioTherapy for Locally Advanced OroPharynx Cancer (ART-OPC) A Phase II Randomized Trial
Secondary ID [1] 0 0
ART-OPC
Universal Trial Number (UTN)
Trial acronym
ART-OPC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oropharynx Cancer 0 0
Radiotherapy; Complications 0 0
Radiotherapy Side Effect 0 0
Dysphagia 0 0
MRI 0 0
Condition category
Condition code
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Standard radiotherapy +/- chemotherapy
Treatment: Other - Experimental radiotherapy +/- chemotherapy

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.


Treatment: Other: Standard radiotherapy +/- chemotherapy
No radiotherapy adaptation unless major dosimetric deviation

Treatment: Other: Experimental radiotherapy +/- chemotherapy
Systemic MRI-based radiotherapy adaptation mid-treatment
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patient-reported dysphagia
Timepoint [1] 0 0
at 6 months post treatment
Secondary outcome [1] 0 0
Acute and late toxicities
Timepoint [1] 0 0
From treatment start to 5-years after the end of chemoradiation]

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Other
Name
Centre hospitalier de l'Université de Montréal (CHUM)
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Austin Health
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT04901234
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04901234