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Back|NCT05451004Recruiting
Official Title

SPECT-CT Guided ELEctive Contralateral Neck Treatment for Patients With Lateralized Oropharyngeal Cancer. A Phase III Randomized Controlled Trial

Phase
Phase 3
Sponsor
Canadian Cancer Trials Group
Enrollment
510
Timeline
Feb 2023 → Aug 2031
About This Study

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

Inclusion Criteria

  • 1Patients with pathologically proven diagnosis of lateralized OPC (tonsil, tongue base, soft palate, or pharyngeal wall) not involving or crossing midline.
  • 2HPV positive or negative (by p16 immunohistochemistry).
  • 3Clinical 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)
  • 4Radiological investigations within 8 weeks of registration:
  • 5CT or MRI of the neck (with head imaging as indicated);
  • 6PET-CT scan
  • 7Chest CT scan
  • 8Planned definitive RT or CRT with bilateral neck RT (patients planned for unilateral neck RT are excluded).
  • 9Intent 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.
  • 10Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • 11Willing to complete the quality of life and/or health utility questionnaire, if sufficiently fluent in available language(s).
  • 12Informed consent prior to registration
  • 13Accessible for treatment and follow-up.
  • 14Commencement of definitive RT within 28 days (+ 14 days) of randomization.
  • 15Injection procedure for lymphatic mapping may be performed in the nuclear medicine, ambulatory clinic, or operating room setting
  • 16Women/men of childbearing potential must have agreed to use a highly effective contraceptive method
  • 17Patients 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.
  • 18Patient 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

  • 1T1-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.
  • 2Tonsil 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
  • 3Previous head and neck cancer or multiple synchronous primary head and neck cancers
  • 4Previous induction or neo-adjuvant chemotherapy.
  • 5Previous 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
  • 6Radiotracer allergy
  • 7Severe, active co-morbidity including any of the following:
  • 8Chronic Obstructive Pulmonary Disease or other pulmonary illness requiring hospitalization within 30 days of registration
  • 9Unstable angina and/or congestive heart failure requiring hospitalization within the 30 days of registration
  • 10Acute myocardial infarction within 30 days of study registration
  • 11Diseases precluding RT (e.g. scleroderma)

Locations

33 sites participating in this study

Emory University Hospital Midtown

Atlanta, Georgia 30308

Recruiting

James E. Bates

City of Hope Corona

Corona, California 92882

Recruiting

Krupal B. Patel

City of Hope Comprehensive Cancer Center

Duarte, California 91010

Recruiting

Krupal B. Patel

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →