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Clinical Trials/NCT05048459
NCT05048459
Active, Not Recruiting
N/A

Randomized Clinical Trial of Tele-Surveillance and Remote Symptom Monitoring Compared to Standard Surveillance for HPV-Associated Oropharynx Cancer With No Evidence of Disease on Post-Treatment Imaging

Memorial Sloan Kettering Cancer Center1 site in 1 country40 target enrollmentSeptember 1, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Squamous Cell Carcinoma
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
40
Locations
1
Primary Endpoint
Progression-Free Survival (PFS)
Status
Active, Not Recruiting
Last Updated
9 months ago

Overview

Brief Summary

The purpose of this study is to compare standard surveillance with telemedicine surveillance (tele-surveillance) and find out which surveillance approach is best for people with HPV-associated head and neck cancer who have no evidence of disease after treatment. The researches will look at how the two approaches affect participants' quality of life, health outcomes, and expenses (for example, costs of routine visits and procedures). They will also determine doctors' and patients' satisfaction with tele-surveillance.

Registry
clinicaltrials.gov
Start Date
September 1, 2021
End Date
September 1, 2026
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Pathologically (histologically or cytologically) diagnosis of HPV associated squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or oropharyngeal walls)
  • No evidence of disease on post-treatment PET/CT within 9 months of completing radiation therapy. No evidence of disease is a consensus determination by the patient's radiation, medical, and surgical oncologist. If the first PET/CT is equivocal, then a second PET/CT can be obtained within 9 months of completing radiation therapy.
  • Post-treatment diagnostic imaging with either CT or MRI (recommended but not required)
  • Able to speak and read English fluently
  • Able to provide informed consent

Exclusion Criteria

  • Patients on clinical trials related to head and neck cancer that have protocol defined follow up activities
  • Incomplete response or recurrent disease on post-treatment PET/CT
  • Completion of radiation and chemotherapy more than 9 months ago

Outcomes

Primary Outcomes

Progression-Free Survival (PFS)

Time Frame: 2 years

PFS will be defined as pathologic evidence of local or distant tumor progression or death from any cause. Patients

Secondary Outcomes

  • Locoregional recurrence (LRR)(2 years)

Study Sites (1)

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