- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03822897
De-Escalation Radiotherapy in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma (EVADER)
A Phase II Single Arm Trial of Elective Volume Adjusted De-Escalation Radiotherapy (EVADER) in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The standard or usual treatment for this disease includes radiotherapy or radiotherapy combined with chemotherapy or antibody therapy.
These treatments are highly effective at curing most patients with HPV-related cancer of the oropharynx, but short and long-term side effects from treatment can be significant.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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British Columbia
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Prince George, British Columbia, Canada, V2M 7E9
- BCCA - Centre for the North
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Vancouver, British Columbia, Canada, V5Z 4E6
- BCCA - Vancouver Cancer Centre
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- CancerCare Manitoba
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
- Dr. H. Bliss Murphy Cancer Centre
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Juravinski Cancer Centre at Hamilton Health Sciences
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Kingston, Ontario, Canada, K7L 2V7
- Kingston Health Sciences Centre
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Ottawa, Ontario, Canada, K1H 8L6
- Ottawa Hospital Research Institute
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Toronto, Ontario, Canada, M5G 2M9
- University Health Network
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Toronto, Ontario, Canada, M4N 3M5
- Odette Cancer Centre
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Quebec
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Montreal, Quebec, Canada, H4A 3J1
- The Research Institute of the McGill University
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Montreal, Quebec, Canada, H3T 1E2
- The Jewish General Hospital
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Quebec City, Quebec, Canada, G1R 2J6
- Hotel-Dieu de Quebec
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Sherbrooke, Quebec, Canada, J1H 5N4
- CIUSSS de l'Estrie - Centre hospitalier
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Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
- Allan Blair Cancer Centre
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with pathologically proven diagnosis of HPV-related OPSCC
- Clinical stage T1-3 N0-1 M0 (UICC/AJCC 8th Ed.)
- Patients must be eligible for definitive RT or CRT
- Must be ≥ 18 years of age
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life and health economics questionnaires in either English or French
- Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrolment in the trial to document their willingness to participate
- Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
- In accordance with CCTG policy, protocol treatment is to begin within 3 weeks of patient registration
- Women/men of childbearing potential must have agreed to use a highly effective contraceptive method
- The following radiological investigations must be done within 8 weeks of randomization: CT or MR of head and neck (MRI is recommended for base-of-tongue primary tumors); PET-CT scan.
- Patient must consent to provision of, and investigator(s) must confirm location and commit to obtain a representation of formalin-fixed paraffin block of non-cytology tumour tissue in order that the specific correlative marker assays described in Section 12 (Correlative Studies) may be conducted. Please see the Correlative Manual for details
- Patient must consent to provision of samples of blood and plasma (for circulating cell free DNA) in order that the specific correlative marker assays described may be conducted.
- Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Exclusion Criteria:
- Previous chemotherapy or radiotherapy treatment for head and neck cancer
- Patients with an unknown primary.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Two Treatment Options
Option #1 - Radiotherapy 35 fractions, 5/wk, 7 wks 70Gy/56Gy Cisplatin 100mg/m2 on day 1, 22 and 43 or 40mg mg/m2/wk for 7 wks Option #2 - Radiation only-35 fraction, 6/wk, 6wks 70Gy/56Gy |
35 fractions, 5/wk, 7 wks 70Gy/56Gy, or 35 fractions, 6/wk, 6 wks, 70Gy/56Gy, or 35 fractions, 5/wk, 7 wks OR 6/wk, 6 wks 70Gy/56Gy
Other Names:
100 mg/m2 on day 1, 22, and 43 or 40 mg/m2 /wk for 7 wks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Event-free Survival
Time Frame: 5 years
|
Time to first progress event or censoring in year
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: 5 years
|
Time to death or censoring in year
|
5 years
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Local control
Time Frame: 5 years
|
Percentage of patients with local control
|
5 years
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Regional Control
Time Frame: 5 years
|
Percentage of patients with regional control
|
5 years
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Locoregional control
Time Frame: 5 years
|
Percentage of patients with local and regional control
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5 years
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Distant Metastasis-Free Survival
Time Frame: 5 years
|
Time to distant metastasis or censoring in year
|
5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Scott Bratman, Princess Margaret Cancer Centre, Toronto, ON
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Neoplasms, Squamous Cell
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Oropharyngeal Neoplasms
- Antineoplastic Agents
- Cisplatin
Other Study ID Numbers
- HN10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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