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Adaptive RadioTherapy for OroPharynx Cancer (ART-OPC)

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ClinicalTrials.gov Identifier: NCT04901234
Recruitment Status : Recruiting
First Posted : May 25, 2021
Last Update Posted : August 6, 2021
Sponsor:
Collaborator:
Austin Health
Information provided by (Responsible Party):
Houda Bahig, Centre hospitalier de l'Université de Montréal (CHUM)

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.

Condition or disease Intervention/treatment Phase
Oropharynx Cancer Radiotherapy; Complications Radiotherapy Side Effect Dysphagia MRI Radiation: Standard radiotherapy +/- chemotherapy Radiation: Experimental radiotherapy +/- chemotherapy Phase 2

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 the entire treatment duration, unless major dosimetric deviations are detected. The use of MRI for treatment adaptation has the advantage of increased soft tissue contrast and is being integrated into several clinical practises with the recent development of MR-Linac technology. However, there is currently no demonstrated clinical advantage from the use of MRI for treatment adaptation in head and neck cancer.

Primary objective: 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.

Methods: 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. Patients with contra-indications to MRI will be excluded. The study will use a 2-sided, independent-sample t-test with an alpha level of 0.05 and power of 80%, with a 1:1 randomization between the 2 arms. In order to detect a 10-point improvement in the MD Anderson Dysphagia Index (MDADI) and assuming that the quality of life scores would be normally distributed with a standard deviation of 18, a total of 104 patients will be required (52 in each arm), which has been increased to 120 patients overall (60 patients in each arm) to account for a 10% dropout rate in completion of the quality of life scoring at 6 months post-treatment. An independent DSMB will review the pooled standard deviation of the interim data collected for this trial after 40 patients overall have been recruited (20 in each arm) the value of the standard deviation used to calculate the sample size required. The DSMB will inform the study team if there is potential to reduce the sample size if the standard deviation was much lower than 18 (i.e. <=15 would result in a reduction of 25% in patients required), which will potential reduce the length of the trial. Patients will be stratified by institution and recruited in blocks of 4 to ensure a balance between arms at the interim assessment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase II open label randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adaptive RadioTherapy for Locally Advanced OroPharynx Cancer (ART-OPC) A Phase II Randomized Trial
Actual Study Start Date : July 30, 2021
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : June 2027

Arm Intervention/treatment
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.
Radiation: Standard radiotherapy +/- chemotherapy
No radiotherapy adaptation unless major dosimetric deviation

Experimental: Adaptive radiotherapy
Systematic radiation treatment plan adaptation according to the shrinking tumour on mid-treatment MRI.
Radiation: Experimental radiotherapy +/- chemotherapy
Systemic MRI-based radiotherapy adaptation mid-treatment




Primary Outcome Measures :
  1. Patient-reported dysphagia [ Time Frame: at 6 months post treatment ]
    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.


Secondary Outcome Measures :
  1. Acute and late toxicities [ Time Frame: From treatment start to 5-years after the end of chemoradiation] ]
    Rate of grade ≥ 3 late toxicity as per CTCAE v5.0


Other Outcome Measures:
  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 ]
  5. Patient-reported dysphagia [ Time Frame: [Time Frame: At baseline, and 1-, 3-, 12- months post-treatment, and yearly up to 5 years after the end of chemoradiation] ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04901234


Locations
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Australia
Austin Health Not yet recruiting
Melbourne, Australia
Contact: Sweet Ping Ng, MD PhD         
Principal Investigator: Sweet Ping Ng, MD PhD         
Canada, Quebec
Centre Hospitalier de l'Université de Montréal Recruiting
Montréal, Quebec, Canada, H2x 3E4
Contact: Mom Phat    514-890-8254    mom.phat.chum@ssss.gouv.qc.ca   
Contact: Silvine Benth    514-890-8254    mom.phat.chum@ssss.gouv.qc.ca   
Principal Investigator: Edith Filion, MD         
Sub-Investigator: Houda Bahig, MD PhD         
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Austin Health
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Responsible Party: Houda Bahig, Radiation Oncologist, Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT04901234    
Other Study ID Numbers: ART-OPC
First Posted: May 25, 2021    Key Record Dates
Last Update Posted: August 6, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Houda Bahig, Centre hospitalier de l'Université de Montréal (CHUM):
Oropharynx cancer
Radiotherapy
Adaptation
Magnetic resonance imaging
Additional relevant MeSH terms:
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Oropharyngeal Neoplasms
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Stomatognathic Diseases