Ignite Creation Date:
2024-05-06 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06088381
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2023-09-28
Brief Title:
Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels SAVAL
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Single Arm Phase II Trial Evaluating Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels SAVAL
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAVAL
Brief Summary:
Patients with human papillomavirus HPV-related oropharyngeal cancer generally have favorable outcomes and how well they do depends on the specific details about the patient and their cancer How well they do isnt as related to the kinds of treatment they get However there are significant side effects for the various types of treatments they may get Because these patients generally have favorable outcomes no matter the kind of treatment reducing side effects should be a priority when choosing their treatment
The goal of this clinical research study is to evaluate whether a new blood test called a Circulating Tumor DNA test ctDNA test can decrease the number of people that require radiation after surgery This blood test is often elevated in people when they are diagnosed with head and neck cancer There are studies that show that cancer most often returns when this blood test is positive after treatment This study will test patients blood before and after surgery In cases where the test is negative after surgery people on the study will not receive radiation unless they are considered high risk based on surgery findings The hope is that radiation and its potential side effects can be limited to only people that need the treatment
The goal of this clinical research study is to evaluate whether a new blood test called a Circulating Tumor DNA test ctDNA test can decrease the number of people that require radiation after surgery This blood test is often elevated in people when they are diagnosed with head and neck cancer There are studies that show that cancer most often returns when this blood test is positive after treatment This study will test patients blood before and after surgery In cases where the test is negative after surgery people on the study will not receive radiation unless they are considered high risk based on surgery findings The hope is that radiation and its potential side effects can be limited to only people that need the treatment
Detailed Description:
Patients with human papillomavirus HPV or its surrogate marker p16 positive oropharyngeal squamous cell carcinoma hereafter p16OPSCC exhibit favorable overall survival rates of 70-100 at 3 years These outcomes are dependent on disease burden and patient characteristics and independent of treatment modality Significant treatment related side effects exist despite advances in radiotherapy technology surgical techniques and supportive care In addition to common acute toxicities their favorable overall survival potentially places these patients at increased risk for developing long-term treatment-induced side-effects Therefore it is important to establish novel management approaches that maintain excellent current clinical outcomes while effectively reducing acute and long-term side effects
The de-escalation trials for surgical management have explored various combinations of dose-reduction while preserving favorable oncologic outcomes for patients Prospective trials have demonstrated efficacy safety and functional benefit following treatment reduction to the primary tumor regional lymph node metastasis and the elective nodal volume Therefore newer approaches of combining the treatment modifications from each of these treatment fields offer the potential to have substantial harm reduction for future patients
Cell free HPV tumor DNA ctDNA has emerged as a method to monitor the presence of disease and is a promising biomarker Changes in expression of ctDNA post treatment with TransOral Robotic Surgery TORS or radiation therapy RT with or without chemotherapy are observed and clearance of ctDNA is associated with a favorable prognosis These promising findings have led several groups to initiate clinical trials evaluating observation in patients after definitive oropharyngeal cancer removal and subsequent clearance of ctDNA levels Data suggests that patients who initially undergo observation following TORS have similar rates of distant metastases and favorable rates of salvage To date an observation-based approach has not been adopted for intermediate risk patients due to challenges identifying optimal cohorts for observation and concern for increased treatment related toxicity for patients who do require salvage In this trial the investigators propose use of ctDNA clearance to identify patients who are optimal for observation This protocol tests the hypothesis that patients currently recommended for adjuvant RT based on intermediate risk factors can be observed post-TORS when ctDNA is cleared
Patients with p16OPSCC who are candidates for surgery TORS and have positive ctDNA will be offered registration for the study prior to surgical resection After TORS all patients will have ctDNA drawn within 2-14 days post operatively Combined with pathological criteria all patients will be stratified into one three risk groups low risk intermediate risk high risk The low risk group will be observed no radiation per standard of care SOC The intermediate group intermediate pathological features and negative ctDNA will also be observed no radiation per the experimental arm The high risk group will receive adjuvant treatment RT - chemotherapy per SOC
The de-escalation trials for surgical management have explored various combinations of dose-reduction while preserving favorable oncologic outcomes for patients Prospective trials have demonstrated efficacy safety and functional benefit following treatment reduction to the primary tumor regional lymph node metastasis and the elective nodal volume Therefore newer approaches of combining the treatment modifications from each of these treatment fields offer the potential to have substantial harm reduction for future patients
Cell free HPV tumor DNA ctDNA has emerged as a method to monitor the presence of disease and is a promising biomarker Changes in expression of ctDNA post treatment with TransOral Robotic Surgery TORS or radiation therapy RT with or without chemotherapy are observed and clearance of ctDNA is associated with a favorable prognosis These promising findings have led several groups to initiate clinical trials evaluating observation in patients after definitive oropharyngeal cancer removal and subsequent clearance of ctDNA levels Data suggests that patients who initially undergo observation following TORS have similar rates of distant metastases and favorable rates of salvage To date an observation-based approach has not been adopted for intermediate risk patients due to challenges identifying optimal cohorts for observation and concern for increased treatment related toxicity for patients who do require salvage In this trial the investigators propose use of ctDNA clearance to identify patients who are optimal for observation This protocol tests the hypothesis that patients currently recommended for adjuvant RT based on intermediate risk factors can be observed post-TORS when ctDNA is cleared
Patients with p16OPSCC who are candidates for surgery TORS and have positive ctDNA will be offered registration for the study prior to surgical resection After TORS all patients will have ctDNA drawn within 2-14 days post operatively Combined with pathological criteria all patients will be stratified into one three risk groups low risk intermediate risk high risk The low risk group will be observed no radiation per standard of care SOC The intermediate group intermediate pathological features and negative ctDNA will also be observed no radiation per the experimental arm The high risk group will receive adjuvant treatment RT - chemotherapy per SOC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None