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

NCT ID: NCT03822897

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-28
• Study Completion Date: 2025-12-31

Brief 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

Oropharyngeal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental arm

This is a non-randomized, single-arm study evaluating elective volume-adjusted de-escalation radiotherapy. Patients receive one of two treatment options, based on treating physician discretion. Both options are considered part of a unified treatment strategy and analyzed as a single arm.

• Option 1 (Chemoradiotherapy):

Radiotherapy: 70 Gy to the high-risk volume and 56 Gy to the elective volume, delivered in 35 fractions over 7 weeks (5 fractions/week) Cisplatin: Either 100 mg/m² on days 1, 22, and 43 or 40 mg/m² weekly for 7 weeks

• Option 2 (Radiotherapy Alone):

Radiotherapy: 70 Gy to the high-risk volume and 56 Gy to the elective volume, delivered in 35 fractions over 6 weeks (6 fractions/week)

Group Type: OTHER

Radiation

Intervention Type: RADIATION

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

Cisplatin

Intervention Type: DRUG

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

Interventions

Radiation

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

Intervention Type: RADIATION

Cisplatin

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

Intervention Type: DRUG

Other Intervention Names

No available; No available

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Cancer Trials Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Bratman

Role: STUDY_CHAIR

Princess Margaret Cancer Centre, Toronto, ON

Locations

BCCA - Centre for the North

Prince George, British Columbia, Canada

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, Canada

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Dr. H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, Canada

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, Canada

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Odette Cancer Centre

Toronto, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

The Jewish General Hospital

Montreal, Quebec, Canada

The Research Institute of the McGill University

Montreal, Quebec, Canada

Hotel-Dieu de Quebec

Québec, Quebec, Canada

CIUSSS de l'Estrie - Centre hospitalier

Sherbrooke, Quebec, Canada

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

HN10

Identifier Type: -

Identifier Source: org_study_id