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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCanadian Cancer Trials Group

About this trial

This study is being done to answer the following question:

Is the chance of cancer spreading or returning the same if radiotherapy to the neck is guided, by using a special imaging study called lymph node mapping (lymphatic mapping) Single Photon Emission Computed Tomography (SPECT-CT), compared to the usual treatment when radiotherapy is given to both sides of the neck?

Eligibility criteria

Qualifiers

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)

CT or MRI of the neck (with head imaging as indicated);

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Lymphatic Mapping with SPECT-CT
  • Ipsilateral and Contralateral Neck

Treatment groups

510 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Canadian Cancer Trials Group

Lead sponsor

Alliance for Clinical Trials in Oncology

Collaborator

Eastern Cooperative Oncology Group

Collaborator

NRG Oncology

Collaborator

SWOG Cancer Research Network

Collaborator