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

Oropharyngeal Cancer Clinical Trial

— EVADER  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03822897
• Other study ID #: HN10
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 28, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Canadian Cancer Trials Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 103
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Oropharyngeal Cancer
• Oropharyngeal Neoplasms
• Squamous Cell Carcinoma of Head and Neck

Intervention

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

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

Locations

Country	Name	City	State
Canada	Juravinski Cancer Centre at Hamilton Health Sciences	Hamilton	Ontario
Canada	Kingston Health Sciences Centre	Kingston	Ontario
Canada	The Jewish General Hospital	Montreal	Quebec
Canada	The Research Institute of the McGill University	Montreal	Quebec
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario
Canada	BCCA - Centre for the North	Prince George	British Columbia
Canada	Hotel-Dieu de Quebec	Quebec City	Quebec
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
Canada	CIUSSS de l'Estrie - Centre hospitalier	Sherbrooke	Quebec
Canada	Dr. H. Bliss Murphy Cancer Centre	St. John's	Newfoundland and Labrador
Canada	Odette Cancer Centre	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario
Canada	BCCA - Vancouver Cancer Centre	Vancouver	British Columbia
Canada	CancerCare Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Canadian Cancer Trials Group

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free Survival	Time to first progress event or censoring in year	5 years
Secondary	Overall Survival	Time to death or censoring in year	5 years
Secondary	Local control	Percentage of patients with local control	5 years
Secondary	Regional Control	Percentage of patients with regional control	5 years
Secondary	Locoregional control	Percentage of patients with local and regional control	5 years
Secondary	Distant Metastasis-Free Survival	Time to distant metastasis or censoring in year	5 years