Guided neck treatment for patients with oropharyngeal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates whether using SPECT-CT guided lymphatic mapping for radiotherapy in patients with lateralized oropharyngeal cancer is as effective as the standard treatment, which involves radiotherapy to both sides of the neck. The goal is to determine if this targeted approach can control cancer spread or recurrence while potentially reducing side effects and improving quality of life. Patients will receive either the guided treatment or the usual bilateral neck radiotherapy as part of the trial.

Why it matters

Who can join: the full rules

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)

Where it's running

• City of Hope Corona
  Corona, California, United States Recruiting
• City of Hope Comprehensive Cancer Center
  Duarte, California, United States Recruiting
• UM Sylvester Comprehensive Cancer Center at Coral Gables
  Coral Gables, Florida, United States Recruiting
• University of Miami Miller School of Medicine-Sylvester Cancer Center
  Miami, Florida, United States Recruiting
• Moffitt Cancer Center-International Plaza
  Tampa, Florida, United States Recruiting
• Moffitt Cancer Center - McKinley Campus
  Tampa, Florida, United States Recruiting

Study contacts

• Study coordinator: Wendy Parulekar
• Email: wparulekar@ctg.queensu.ca
• Phone: 613-533-6430

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Selective dose reduction of neck radiation in HPV-associated oropharyngeal cancer

  This trial tests whether lowering radiation doses to certain neck lymph nodes or gross disease areas is safe and can reduce side effects for adults with HPV-related oropharyngeal cancer.

  Recruiting at 4 sites Phase 2 University of Maryland, Baltimore · Baltimore, Maryland and 3 other locations · NCT07418034

• Toripalimab plus standard treatment for HPV-positive throat cancer

  This trial tests whether adding toripalimab to chemotherapy followed by surgery or lower-dose radiation can help adults with HPV16-positive, locoregionally advanced oropharyngeal (throat) cancer.

  Recruiting Phase 2 University of Chicago · Chicago, Illinois · NCT07290621

• Neoadjuvant chemoimmunotherapy with PD-1 blockade to reduce surgery for advanced head and neck cancer

  This approach will try a short course of chemotherapy plus the PD-1 drug toripalimab before standard treatment for people with advanced head and neck cancers to shrink tumors and allow less extensive surgery or radiation.

  Recruiting Phase 2 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Baltimore, Maryland · NCT07209189

• Lidocaine injection before surgery for oropharyngeal cancer

  This study tests if giving a lidocaine injection before surgery can help improve outcomes for patients with oropharyngeal cancer.

  Recruiting Phase 1 Abramson Cancer Center at Penn Medicine · Philadelphia, Pennsylvania · NCT06747390

• Image-guided proton therapy for advanced head and neck cancer

  This study is testing a new way to use proton therapy combined with chemotherapy to see if it can safely deliver a higher dose to treat advanced head and neck cancer while protecting healthy tissue.

  Recruiting Phase 1 University Medical Center Groningen · Groningen · NCT06446713

• Using circulating tumor DNA to tailor post-surgery treatment for HPV-related throat cancer

  This study is testing if adjusting cancer treatment based on blood tests for HPV DNA can help people with throat cancer after surgery feel better and improve their outcomes.

  Recruiting at 4 sites Phase 2 Cedars-Sinai Medical Center · Beverly Hills, California and 3 other locations · NCT06445114

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.