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Trial of De-Intensified Post-operative Chemoradiation Following Robotic Surgery for HPV-positive Oropharyngeal Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started2021-02-16
View on ClinicalTrials.gov ↗

Amendment history

2026-08-03
minor
4 amendments v14-v17
4 re-verifications since 2025-09-02, no change to tracked fields
2025-02-11
notable
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v13
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 4 of 4 sites
2025-02-03
minor
2 amendments v11-v12
2 re-verifications since 2024-08-01, no change to tracked fields
2024-02-02
notable
Active, Not Recruiting→Recruiting Study Status, Contacts/Locations v10
Trial statusActive, Not Recruiting→Recruiting
Study sitesdetails revised at 4 of 4 sites
2024-02-01
minor
Study Status v9
Primary completion date2023-12-15→2026-12-15
Completion date2025-09-15→2029-12-15
Show 8 earlier versions
2023-10-24
notable
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v8
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 4 of 4 sites
2023-10-09
minor
Study Status v7
Primary completion date2023-09-15→2023-12-15
2023-03-02
minor
Study Status, Study Description, Study Design v6
Enrollment target36→40
2022-07-06
minor
Study Status v5
Re-verified, no change to tracked fields
2022-01-07
minor
Study Status, Contacts/Locations v4
Study sites3→4
2021-10-04
minor
Study Status v3
Re-verified, no change to tracked fields
2021-04-14
minor
Study Status, Contacts/Locations v2
Study sitesdetails revised at 2 of 3 sites
2021-02-16
notable
Not Yet Recruiting→Recruiting Study Status, Sponsor/Collaborators, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2020-10-01→confirmed 2021-02-16
Study sites2→3
2020-08-04
minor
Original filing
This study will enroll patients with HPV-associated oropharyngeal cancer, undergoing resection of all gross visible disease at the primary site and in the lymph nodes. A total of 40 patients who have had or will require surgery to remove cancer cells prior to starting chemoradiation may be enrolled. All eligible patients will receive de-intensified cisplatin-based chemoradiation, with high-risk patients receiving a higher dose and longer treatment period than other patients on the study. The study will assess whether a de-intensified version of standard chemoradiation treatment will be just as effective in treating HPV-associated oropharyngeal cancer while causing less side effects than standard dosing.
Trial Details
NCT Number NCT04502407
Lead Sponsor Cedars-Sinai Medical Center
Conditions HPV Positive Oropharyngeal Squamous Cell Carcinoma
Enrollment 40 participants
Start Date 2021-02-16
Primary Completion 2026-12-15 (estimated)
Study Completion 2029-12-15 (estimated)
Updated on ClinicalTrials.gov 2026-08-05