SPECT-CT Guided ELEctive Contralateral Neck Treatment for Patients With Lateralized Oropharyngeal Cancer

Launched by CANADIAN CANCER TRIALS GROUP · Jul 5, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new way to deliver radiation therapy for patients with oropharyngeal cancer, which affects parts of the throat like the tonsils and soft palate. The researchers want to find out if using a special imaging technique called SPECT-CT to guide the treatment can provide the same level of cancer control as the traditional method, where both sides of the neck are treated with radiation. This study is important because it may help reduce unnecessary treatment on one side of the neck, potentially leading to fewer side effects.

To participate, patients should be between 65 and 74 years old and have a confirmed diagnosis of oropharyngeal cancer that hasn't spread across the midline of the throat. They should not have had prior treatments for head and neck cancer or significant other health issues that could complicate their care. If eligible, participants will receive detailed instructions about the treatment process, which includes a special imaging procedure to help guide their radiation therapy. The study also involves completing questionnaires about their quality of life, and patients must be willing to provide consent and follow up with the research team.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with pathologically proven diagnosis of lateralized OPC (tonsil, tongue base, soft palate, or pharyngeal wall) not involving or crossing midline.
• • HPV positive or negative (by p16 immunohistochemistry).
• • Clinical stage T1-3 M0 (UICC/AJCC TNM 8th Edition). Nodal involvement may include no nodes or single or multiple ipsilateral lymph nodes (largest ≤6cm in maximum diameter)
• * Radiological investigations within 8 weeks of registration:
• • CT or MRI of the neck (with head imaging as indicated);
• • PET-CT scan
• • Chest CT scan
• • Planned definitive RT or CRT with bilateral neck RT (patients planned for unilateral neck RT are excluded).
• • Intent to deliver concurrent chemotherapy or not must be known at the time of randomization. As this is a pragmatic trial, even patients who are not candidates for systemic therapy will be eligible for participation.
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• • Willing to complete the quality of life and/or health utility questionnaire, if sufficiently fluent in available language(s).
• • Informed consent prior to registration
• • Accessible for treatment and follow-up.
• • Commencement of definitive RT within 28 days (+ 14 days) of randomization.
• • Injection procedure for lymphatic mapping may be performed in the nuclear medicine, ambulatory clinic, or operating room setting
• • Women/men of childbearing potential must have agreed to use a highly effective contraceptive method
• • Patients with a 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.
• • Patient must consent to provision of, and investigator(s) must confirm location and commitment to obtain a representation of formalin fixed paraffin block of non-cytology tumour tissue in order that the specific correlative marker assays
• Exclusion Criteria:
• • T1-T2 cancers isolated to the tonsil fossa (i.e. without any soft palate, tongue base, posterior pharyngeal wall or posterior tonsil pillar involvement) with no involved lymph nodes or with a single ipsilateral node \< 3 cm without extranodal extension.
• • Tonsil or tongue base primary cancer who have previously undergone diagnostic palatine or lingual tonsillectomy with either complete excision or with no clinically apparent residual disease
• • Previous head and neck cancer or multiple synchronous primary head and neck cancers
• • Previous induction or neo-adjuvant chemotherapy.
• • Previous radiation therapy to the head and neck or comprehensive neck dissection of at least 3 levels on either side (due to potential for disrupted lymphatic channels and drainage pathways). Patients who have had excisional biopsies of involved lymph nodes are eligible
• • Radiotracer allergy
• * Severe, active co-morbidity including any of the following:
• • Chronic Obstructive Pulmonary Disease or other pulmonary illness requiring hospitalization within 30 days of registration
• • Unstable angina and/or congestive heart failure requiring hospitalization within the 30 days of registration
• • Acute myocardial infarction within 30 days of study registration
• • Diseases precluding RT (e.g. scleroderma)