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
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Phase II open label randomized controlled trial|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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
- Locoregional control [ Time Frame: at 6 months, 2 and 5 years ]
- Disease-free survival [ Time Frame: at 6 months, 2 and 5 years ]
- Overall survival [ Time Frame: at 6 months, 2 and 5 years ]
- Complete response rate [ Time Frame: at 6 months ]
- 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.
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
|Austin Health||Not yet recruiting|
|Contact: Sweet Ping Ng, MD PhD|
|Principal Investigator: Sweet Ping Ng, MD PhD|
|Centre Hospitalier de l'Université de Montréal||Recruiting|
|Montréal, Quebec, Canada, H2x 3E4|
|Contact: Mom Phat 514-890-8254 firstname.lastname@example.org|
|Contact: Silvine Benth 514-890-8254 email@example.com|
|Principal Investigator: Edith Filion, MD|
|Sub-Investigator: Houda Bahig, MD PhD|