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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Lymphatic Mapping with SPECT-CT

    Other intervention

    Radiation: Ipsilateral Neck Radiotherapy and SPECT-CT Guided Contralateral Neck Radiotherapy

  • Ipsilateral and Contralateral Neck

    Radiation

    Radiotherapy

Treatment groups

510 Participants
are divided into 2 treatment groups
Group A: Lympathic Mapping with SPECT-CT guided RadiotherapyExperimental treatment 1 intervention
Group B: Bilateral Neck RadiotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Disease-free Survival

Time frame
8 years

Secondary outcomes

1

Quality of Life using M.D. Anderson Dysphagia Inventory (MDADI)

Possible range of scores between 0 and 100 (higher scores indicating better swallowing and lower score indicating poor swallowing).

Time frame
8 years
2

Xerostomia-related Quality of Life using Xerostomia Questionnaire (XQ)

Clinically meaningful worsening of xerostomia (10 units on XQ) from baseline to 12 months post RT

Time frame
8 years
3

Isolated contralateral neck failure (iCNF)

Time frame
8 years
4

Overall Survival (OS)

Time frame
8 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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