De-Escalation Radiotherapy in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carc… (NCT03822897) | Clinical Trial Compass
Active — Not RecruitingPhase 2
De-Escalation Radiotherapy in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma
Canada103 participantsStarted 2019-06-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 orde…