Status:
ACTIVE_NOT_RECRUITING
De-Escalation Radiotherapy in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma
Lead Sponsor:
Canadian Cancer Trials Group
Conditions:
Oropharyngeal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 wi...
Eligibility Criteria
Inclusion
- 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
- Previous chemotherapy or radiotherapy treatment for head and neck cancer
- Patients with an unknown primary.
Key Trial Info
Start Date :
June 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT03822897
Start Date
June 28 2019
End Date
December 31 2025
Last Update
September 30 2025
Active Locations (14)
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1
BCCA - Centre for the North
Prince George, British Columbia, Canada, V2M 7E9
2
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
3
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
4
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6