De-Escalation Radiotherapy in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma
- Conditions
- Oropharyngeal Cancer
- Interventions
- Radiation: Radiation
- Registration Number
- NCT03822897
- Lead Sponsor
- Canadian Cancer Trials Group
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 103
- 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.
- Previous chemotherapy or radiotherapy treatment for head and neck cancer
- Patients with an unknown primary.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Two Treatment Options Radiation 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 Two Treatment Options Cisplatin 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
- Primary Outcome Measures
Name Time Method Event-free Survival 5 years Time to first progress event or censoring in year
- Secondary Outcome Measures
Name Time Method Overall Survival 5 years Time to death or censoring in year
Regional Control 5 years Percentage of patients with regional control
Locoregional control 5 years Percentage of patients with local and regional control
Local control 5 years Percentage of patients with local control
Distant Metastasis-Free Survival 5 years Time to distant metastasis or censoring in year
Trial Locations
- Locations (14)
Juravinski Cancer Centre at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Kingston Health Sciences Centre
🇨🇦Kingston, Ontario, Canada
The Research Institute of the McGill University
🇨🇦Montreal, Quebec, Canada
BCCA - Centre for the North
🇨🇦Prince George, British Columbia, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
BCCA - Vancouver Cancer Centre
🇨🇦Vancouver, British Columbia, Canada
Odette Cancer Centre
🇨🇦Toronto, Ontario, Canada
Ottawa Hospital Research Institute
🇨🇦Ottawa, Ontario, Canada
The Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Hotel-Dieu de Quebec
🇨🇦Quebec City, Quebec, Canada
CIUSSS de l'Estrie - Centre hospitalier
🇨🇦Sherbrooke, Quebec, Canada
Dr. H. Bliss Murphy Cancer Centre
🇨🇦St. John's, Newfoundland and Labrador, Canada
University Health Network
🇨🇦Toronto, Ontario, Canada
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada