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New treatment option for Oropharyngeal Cancer
Official title SPECT-CT Guided ELEctive Contralateral Neck Treatment for Patients With Lateralized Oropharyngeal Cancer
ClinicalTrials.gov ID: NCT05451004
What this study is testing
- What it's testing
- 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?
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with pathologically proven diagnosis of lateralized OPC (tonsil, tongue base, soft palate, or pharyngeal wall) not involving or crossing...
- 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...
- Radiological investigations within 8 weeks of registration:
- CT or MRI of the neck (with head imaging as indicated);
You likely can't join if
- T1-T2 cancers isolated to the tonsil fossa (i.e. without any soft palate, tongue base, posterior pharyngeal wall or posterior tonsil pillar...
- Tonsil or tongue base primary cancer who have previously undergone diagnostic palatine or lingual tonsillectomy with either complete excision or with...
- 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...
- Radiotracer allergy
See the full eligibility 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 how well it works assessment of the investigational regimen are eligible for...
- 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...
- 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 \<...
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Corona, California, United States
- Duarte, California, United States
- Irvine, California, United States
- Coral Gables, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Warrenville, Illinois, United States
- Louisville, Kentucky, United States
- Ann Arbor, Michigan, United States
- Brighton, Michigan, United States
- Detroit, Michigan, United States
- Columbia, Missouri, United States
- Chapel Hill, North Carolina, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Conroe, Texas, United States
- Houston, Texas, United States
+ 11 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Corona, California, United States; Duarte, California, United States; Irvine, California, United States; Coral Gables, Florida, United States; Jacksonville, Florida, United States; Miami, Florida, United States and 25 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.