SPECT-CT Guided ELEctive Contralateral Neck Treatment for Patients With Lateralized Oropharyngeal Cancer (SELECT)
Primary Purpose
Oropharyngeal Cancer
Status
Recruiting
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Lymphatic Mapping with SPECT-CT
Ipsilateral and Contralateral Neck
Sponsored by
About this trial
This is an interventional treatment trial for Oropharyngeal Cancer
Eligibility Criteria
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)
Sites / Locations
- University Health Network-Princess Margaret Cancer CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lympathic Mapping with SPECT-CT guided Radiotherapy
Bilateral Neck Radiotherapy
Arm Description
Outcomes
Primary Outcome Measures
Disease-free Survival
Secondary Outcome Measures
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).
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
Isolated contralateral neck failure (iCNF)
Overall Survival (OS)
Logo-regional Failure (LRF)
Distant Metastases (DM)
Incidence and Severity of Radiation-related Toxicities
Patient-Reported Toxicities using PRO CTCAE
Gastrostomy Tube Usage
Resource Utilization
Lost Productivity
Healthcare system and societal resources will be quantified over the course of the trial to generate utilization information by patient in each study arm. We will generate an average cost per study subject by treatment arm for an overall mean cost per study arm
Financial Toxicity [Financial Index of Toxicity (FIT)]
Health Utilities using EQ-5D
Full Information
NCT ID
NCT05451004
First Posted
June 30, 2022
Last Updated
August 3, 2023
Sponsor
Canadian Cancer Trials Group
Collaborators
Alliance for Clinical Trials in Oncology, Eastern Cooperative Oncology Group, NRG Oncology, SWOG Cancer Research Network
1. Study Identification
Unique Protocol Identification Number
NCT05451004
Brief Title
SPECT-CT Guided ELEctive Contralateral Neck Treatment for Patients With Lateralized Oropharyngeal Cancer
Acronym
SELECT
Official Title
SPECT-CT Guided ELEctive Contralateral Neck Treatment for Patients With Lateralized Oropharyngeal Cancer. A Phase III Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2023 (Actual)
Primary Completion Date
August 30, 2030 (Anticipated)
Study Completion Date
August 30, 2031 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Canadian Cancer Trials Group
Collaborators
Alliance for Clinical Trials in Oncology, Eastern Cooperative Oncology Group, NRG Oncology, SWOG Cancer Research Network
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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?
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharyngeal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
510 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lympathic Mapping with SPECT-CT guided Radiotherapy
Arm Type
Experimental
Arm Title
Bilateral Neck Radiotherapy
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Lymphatic Mapping with SPECT-CT
Intervention Description
Radiation: Ipsilateral Neck Radiotherapy and SPECT-CT Guided Contralateral Neck Radiotherapy
Intervention Type
Radiation
Intervention Name(s)
Ipsilateral and Contralateral Neck
Intervention Description
Radiotherapy
Primary Outcome Measure Information:
Title
Disease-free Survival
Time Frame
8 years
Secondary Outcome Measure Information:
Title
Quality of Life using M.D. Anderson Dysphagia Inventory (MDADI)
Description
Possible range of scores between 0 and 100 (higher scores indicating better swallowing and lower score indicating poor swallowing).
Time Frame
8 years
Title
Xerostomia-related Quality of Life using Xerostomia Questionnaire (XQ)
Description
Clinically meaningful worsening of xerostomia (10 units on XQ) from baseline to 12 months post RT
Time Frame
8 years
Title
Isolated contralateral neck failure (iCNF)
Time Frame
8 years
Title
Overall Survival (OS)
Time Frame
8 years
Title
Logo-regional Failure (LRF)
Time Frame
8 years
Title
Distant Metastases (DM)
Time Frame
8 years
Title
Incidence and Severity of Radiation-related Toxicities
Time Frame
8 years
Title
Patient-Reported Toxicities using PRO CTCAE
Time Frame
8 years
Title
Gastrostomy Tube Usage
Time Frame
8 years
Title
Resource Utilization
Time Frame
8 years
Title
Lost Productivity
Description
Healthcare system and societal resources will be quantified over the course of the trial to generate utilization information by patient in each study arm. We will generate an average cost per study subject by treatment arm for an overall mean cost per study arm
Time Frame
8 years
Title
Financial Toxicity [Financial Index of Toxicity (FIT)]
Time Frame
8 years
Title
Health Utilities using EQ-5D
Time Frame
8 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wendy Parulekar
Phone
613-533-6430
Email
wparulekar@ctg.queensu.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John R de Almeida
Organizational Affiliation
University Health Network, Princess Margaret Hospital, Toronto ON Canada
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ali Hosni
Organizational Affiliation
University Health Network, Princess Margaret Hospital, Toronto ON Canada
Official's Role
Study Chair
Facility Information:
Facility Name
University Health Network-Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John de Almeida
Phone
416-946-4501
Email
john.dealmeida@uhn.ca
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Based on CCTG Policy
Learn more about this trial
SPECT-CT Guided ELEctive Contralateral Neck Treatment for Patients With Lateralized Oropharyngeal Cancer
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