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

NCT03822897 | Active Not Recruiting Phase 2 Results DMC

• 1 other identifier: HN10
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 14

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.

Conditions

Oropharyngeal Cancer

Outcome Measures

Primary Outcomes (1)

• Event-free Survival

  Event free survival (EFS) is defined as the time from the date of registration to the date of first record of any of the following events: * Progression. * Surgery. * Non-protocol RT, chemotherapy, or biologic therapy (for the current cancer diagnosis) without documentation of the site of failure. * Death due to any cause. The outcome is reported as the proportion of patients who remain event-free at 2 years.

  2 years

Secondary Outcomes (4)

• Overall Survival

  2 years

• Local-regional Control

  2 years

• Out-of-field Regional Control

  2 years

• Distant Metastasis Free Survival

  2 years

Study Arms (1)

Experimental arm

OTHER

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)

Radiation: Radiation; Drug: Cisplatin

Interventions

Cisplatin DRUG

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

Also known as: No available

Experimental arm

Radiation 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

Also known as: No available

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Previous chemotherapy or radiotherapy treatment for head and neck cancer
• Patients with an unknown primary.

Sponsors & Collaborators

• Canadian Cancer Trials Group: lead

Study Sites (14)

BCCA - Centre for the North

Prince George, British Columbia, V2M 7E9, Canada

Location

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Dr. H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

The Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

The Research Institute of the McGill University

Montreal, Quebec, H4A 3J1, Canada

Location

Hotel-Dieu de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

CIUSSS de l'Estrie - Centre hospitalier

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Interventions

Radiation; Cisplatin

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Dr. Wendy Ranjana Parulekar
• Organization: Canadian Cancer Trials Group

wparulekar@ctg.queensu.ca

613 533 6430

Study Officials

• Scott Bratman

  Princess Margaret Cancer Centre, Toronto, ON

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 30, 2019
• Study Start: June 28, 2019
• Primary Completion: June 25, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 17, 2026
• Results First Posted: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (14)