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Active Not RecruitingNCT03822897

De-Escalation Radiotherapy in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma

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

Status
Active Not Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
103 (actual)
Sponsor
Canadian Cancer Trials Group · Network
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to find out whether radiotherapy to some of the lymph node areas can be safely omitted to decrease side effects without increasing the risk of the tumour coming back.

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.

Conditions

Interventions

TypeNameDescription
RADIATIONRadiation35 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
DRUGCisplatin100 mg/m2 on day 1, 22, and 43 or 40 mg/m2 /wk for 7 wks

Timeline

Start date
2019-06-28
Primary completion
2024-06-25
Completion
2026-12-31
First posted
2019-01-30
Last updated
2026-02-17
Results posted
2025-09-30

Locations

14 sites across 1 country: Canada

Source: ClinicalTrials.gov record NCT03822897. Inclusion in this directory is not an endorsement.