Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05541016 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

De-Escalated Adjuvant and Definitive Radiation Therapy Informed by DART 2.0 ctHPV-DNA

StatusRecruiting
PhasePhase 2
Started2023-03-20
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 13 months later Aug 1, 2028 → Sep 6, 2029
See other at-risk trials from Mayo Clinic

Amendment history

2026-10-02
Primary completion pushed: 2028-08-01 → 2029-09-06
Completion pushed: 2029-08-01 → 2029-09-06
2026-05-08
Study Identification, Study Status v13
Re-verified, no change to tracked fields
2025-10-31
Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility v12
Enrollment target320→455
InterventionsBiospecimen Collection (Procedure), Cisplatin (Drug), Computed Tomography (Procedure), Diffusing Alpha-emitter Radiation Therapy…→Biospecimen Collection (Procedure), Cisplatin (Drug), Computed Tomography (Procedure), Diffusing Alpha-emitter Radiation Therapy…
Eligibility criteria+399 characters
[...] formed consent Age >= 18 years Histological confirmation of p16+squamous OPSCCcell carcinoma originating from or HPV(+)suspected OPSCCto be originating from the oropharynx Plan for gross total surgical resection via trans oral surg [...] umors with lymph node less than 3cm, no intermediate or high-risk factors such as lymphatic invasion (LVSI), extranodal extension (ENE), perineural invasion (PNI), positive margin, will gobe offwithdrawn from study and be observed per current clinical standard of care. Patients found to be both HPV negative and p16 negative will be withdrawn from study. Patients foun [...] [...]
Secondary endpointsdetails revised at 1 of 18 entries
Study description+2 characters
[...] t arm. IX. To return to work parameters by treatment arm as assessassessed by the Work Productivity and Activity Impairment Questionna [...]
2025-08-26
2 amendments v10-v11
2 re-verifications since 2025-02-20, no change to tracked fields
2024-08-27
Study Identification, Study Status, Contacts/Locations v9
Study sitescontacts updated at 2 of 3 sites
Study title-58 characters
BloodDe-BasedEscalated Biomarkers to Inform TreatmentAdjuvant and Definitive Radiation Therapy DecisionsInformed forby HPVDART Associated2.0 Oropharyngeal Squamous Cell Head and Neck CancersctHPV-DNA
Show 8 earlier versions
2024-07-08
Study Status, Study Description, Arms and Interventions v8
Study description+355 characters
[...] , and 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 48, and 60 months as well as saliva sample collection at pre-op, end of RT, and any clinical recurrence. GROUP II: Patients undergo DART with/without mucosal spari [...] , and 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 48, and 60 months as well as saliva sample collection at pre-op, end of RT, and any clinical recurrence. GROUP III: Patients undergo intensity-modulated radiation [...] , and 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 48, and 60 months as well as saliva sample collection at pre-op, end of RT, and any clinical recurrence. GROUP IV: Patients undergo IMRT or IMPT [...] [...]
2024-06-25
Study Status v7
Re-verified, no change to tracked fields
2024-01-15
Study Status, Arms and Interventions, Outcome Measures, Contacts/Locations v6
InterventionsBiospecimen Collection (Procedure), Cisplatin (Drug), Computed Tomography (Procedure), Diffusing Alpha-emitter Radiation Therapy…→Biospecimen Collection (Procedure), Cisplatin (Drug), Computed Tomography (Procedure), Diffusing Alpha-emitter Radiation Therapy…
Secondary endpoints18 entries, revised
Functional outcomes - MBBSmodified barium swallow study (MBSS)
Study sitesdetails revised at 1 of 3 sites
2023-10-16
Study Identification, Study Status, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility v5
InterventionsBiospecimen Collection (Procedure), Cisplatin (Drug), Computed Tomography (Procedure), Diffusing Alpha-emitter Radiation Therapy…→Biospecimen Collection (Procedure), Cisplatin (Drug), Computed Tomography (Procedure), Diffusing Alpha-emitter Radiation Therapy…
Eligibility criteria+163 characters
[...] ilateral neck dissection OR chemoradiotherapy with cisplatin. Note: The patient must be cisplatin eligible even if an alternate is used due to drug shortage Absence of distant metastases on standard diagnostic work-up [...] est CT or PET/CT) Eastern Cooperative Oncology Group (ECOG) Performanceperformance Statusstatus (PS) =< 1 Negative pregnancy test done =< 7 days prior to r [...] fected site Prior systemic chemotherapy in the last 5 years HistoryContraindication ofto connectiveradiation tissue disorders suchtherapy as rheumatoiddetermined arthritis,by lupus,the ortreating Sjogren's diseaseteam History of [...] [...]
Secondary endpoints18 entries, revised
Progression-free survival (PFS) follow-up Patient reported outcomes (PROSPROs) Functional outcomes - MBBS Functional outcomes - PROs Proton vs photon treatment toxicity - PROs Proton vs photon treatment toxicity - MBSS Proton vs photon treatment toxicity - dosimetric differences Evaluation of end of treatment treatment circulating human papillomavirus deoxyribonucleic acid (ctHPVDNA) detectability as a marker of risk of progression
Study description-198 characters
[...] hemoradiation Cohort [GROUP 4]) SECONDARY OBJECTIVES: I. To quantifycompare thePFS patternsby oftreatment recurrence and rate of salvage therapy for Low Intermediate Risk (GROUP 1) and MSRT + DARTarm including modifiedat progressionlandmark freetimepoints survival. II. To compareassess functionalthe outcomesdisease-free via modified barium swallow studysurvival (MBSSDFS) and patient reported outcomes (PROs) across treatment groups, as well as in comparisonpatients tothat historicare controlsdisease-free of MSRT, MC1273, and MC1675post-treatment. III. To compare protonoverall vssurvival photon( [...] [...]
Study title-10 characters
[...] Associated Oropharyngeal Squamous Cell Head and Neck Cancers- DART 2.0
2023-10-03
Study Status, Contacts/Locations, References v4
Study sitescontacts updated at 1 of 3 sites
2023-02-21
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-02-15→confirmed 2023-02-21
Study sitesdetails revised at 3 of 3 sites
2023-01-04
Study Identification, Study Status, Sponsor/Collaborators v2
Start date2022-12-15→2023-02-15
Collaborators-31 characters
National Cancer Institute (NCI)
2022-11-29
Study Identification, Study Status v1
Start date2022-11-01→2022-12-15
2022-09-12
Original filing
Mayo Clinic
1,015 trials monitored
See 115 trials at risk
Head & Neck Cancer
2,051 trials monitored
See 116 trials at risk
This phase II trial examines the use of blood-based biomarkers is to help inform decision making for treatment and radiation therapy for patients with human papillomavirus (HPV) positive oropharyngeal squamous cell cancers. The standard treatments for head and neck cancers are radiation therapy with chemotherapy or surgery potentially followed by radiation therapy with or without chemotherapy. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving chemotherapy along with radiation may kill more tumor cells. However, the cancer can recur or can spread to other parts of the body and all treatments can be associated with side effects. The purpose of this study is to evaluate a blood-based biomarker, using the NavDx testing device, for head and neck cancers in order to see if it can help improve selection of the intensity of treatment in order to best balance the side effects of treatment with the goal of decreasing cancer recurrence. This test could aid in early detection of recurrence and salvage therapy.
Trial Details
NCT Number NCT05541016
Lead Sponsor Mayo Clinic
Conditions Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Human Papillomavirus-Related Oropharyngeal Squamous Cell Carcinoma, Stage I Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8, Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Enrollment 455 participants
Start Date 2023-03-20
Primary Completion 2029-09-06 (estimated)
Study Completion 2029-09-06 (estimated)
Updated on ClinicalTrials.gov 2026-10-01