SPECT-CT Guided ELEctive Contralateral Neck Treatment for Patients With Lateralized Oropharyngeal Cancer
Purpose
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?
Condition
- Oropharyngeal Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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)
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Lympathic Mapping with SPECT-CT guided Radiotherapy |
|
|
|
Active Comparator Bilateral Neck Radiotherapy |
|
Recruiting Locations
City of Hope Corona
Corona, California 92882
Corona, California 92882
City of Hope Comprehensive Cancer Center
Duarte, California 91010
Duarte, California 91010
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida 33146
Coral Gables, Florida 33146
Contact:
Site Public Contact
305-243-2647
Site Public Contact
305-243-2647
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida 33136
Miami, Florida 33136
Contact:
Site Public Contact
305-243-2647
Site Public Contact
305-243-2647
Moffitt Cancer Center-International Plaza
Tampa, Florida 33607
Tampa, Florida 33607
Moffitt Cancer Center - McKinley Campus
Tampa, Florida 33612
Tampa, Florida 33612
Moffitt Cancer Center
Tampa, Florida 33612
Tampa, Florida 33612
Emory University Hospital Midtown
Atlanta, Georgia 30308
Atlanta, Georgia 30308
Contact:
Site Public Contact
888-946-7447
Site Public Contact
888-946-7447
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
University of Michigan - Brighton Center for Specialty Care
Brighton, Michigan 48116
Brighton, Michigan 48116
Contact:
Site Public Contact
800-865-1125
Site Public Contact
800-865-1125
Henry Ford Hospital
Detroit, Michigan 48202
Detroit, Michigan 48202
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri 65212
Columbia, Missouri 65212
Contact:
Site Public Contact
573-882-7440
Site Public Contact
573-882-7440
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
Chapel Hill, North Carolina 27599
Providence Portland Medical Center
Portland, Oregon 97213
Portland, Oregon 97213
MD Anderson in The Woodlands
Conroe, Texas 77384
Conroe, Texas 77384
M D Anderson Cancer Center
Houston, Texas 77030
Houston, Texas 77030
MD Anderson West Houston
Houston, Texas 77079
Houston, Texas 77079
MD Anderson League City
League City, Texas 77573
League City, Texas 77573
MD Anderson in Sugar Land
Sugar Land, Texas 77478
Sugar Land, Texas 77478
University of Vermont Medical Center
Burlington, Vermont 05401
Burlington, Vermont 05401
University of Vermont and State Agricultural College
Burlington, Vermont 05405
Burlington, Vermont 05405
More Details
- Status
- Recruiting
- Sponsor
- Canadian Cancer Trials Group
Detailed Description
This study is being conducted in order to find out if this approach is as good as the usual approach in controlling the cancer and has fewer side effects and better quality of life. The usual approach for patients who are not in a study is treatment which includes radiotherapy to the tumour and to both sides of the neck to decrease the risk of spread or recurrence of the cancer