Reduced Elective Nodal and CTV Dose for HPV+ Oropharyngeal Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSara Medek
About this trial
This is a single-arm, phase II study that is designed to investigate nodal and primary tumor CTV dose de-escalation (30 Gy) in HPV positive oropharyngeal cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients must have histologically or cytologically confirmed history of squamous cell carcinoma of the oropharynx (OPSCC) planned for definitive chemoradiation.
Squamous cell carcinoma of the oropharynx (OPSCC) must be confirmed to be p16 positive based on immunohistochemical staining.
OPSCC must be clinical stage T1-4N1-3M0 or T3-T4N0M0 as per AJCC volume 8.
Patients must have measurable disease based on PET/CT imaging completed within 45 days +/- 1 week from date of eligibility confirmation.
Disqualifiers
1. Patients with metastatic or recurrent disease.
Trial design
Design model
Single group
Treatments tested in this trial
Cisplatin
DrugSubjects will continue to receive standard systemic therapy of cisplatin during radiation therapy. Weekly SOC Cisplatin at a dose of 40mg/m2 or every 3-week dosing of 100mg/m2 will be administered per institutional guidelines during radiation therapy. The first cisplatin infusion should be initiated during the window from 24 hours before, to 48 hours after the first scheduled radiation treatment. Skipped cisplatin infusions should not be made up, and the last cisplatin infusion should be no later than 7 days after the last fraction of radiation.
Radiotherapy
RadiationRadiotherapy will involve a sequential boost approach. Treatment will begin with coverage of the primary site and elective nodal regions to 30 Gy, after which treatment volumes will be reduced to primary site and involved nodes only with PTV margin to 70 Gy.
Treatment groups
31 Participants
are divided into 1 treatment groupGroup A: Reduced Elective Nodal and CTV DoseExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in dose and volume to all clinical target volumes (CTV) via Progression-Free Survival (PFS)
To evaluate the efficacy of a reduction in dose and volume to all clinical target volumes (CTV) in patients with HPV-positive squamous cell carcinoma of the oropharynx (OPSCC) using 2-year Progression-Free Survival (PFS). Efficacy will be determined by the PFS rate at 2 years post-treatment, through continuous assessment with a boundary of 10% progression at 2 years (90% 2 year PFS).
Time frame
2 years post treatmentSecondary outcomes
1
Safety evaluated per CTCAE v6
To evaluate safety by collecting adverse events per CTCAE v6 in patients who have HPV positive SCC of the oropharynx using a reduction in primary tumor and nodal CTV dose to 30 Gy.
Time frame
Adverse events collected through 30 days post treatment and SAEs through 90 days post-treatment or until commencement of new anti-cancer therapy, whichever occurs first.2
Quality of life measured by MDADI
The MDADI is a patient-reported outcome (PRO) instrument designed to assess swallowing-related quality of life in patients with head and neck cancer and dysphagia. It evaluates the functional, emotional, and physical impact of swallowing difficulties on daily life. The scale ranges from 20 - 100. Higher scores indicate better swallowing function and better swallowing-related quality of life. Lower scores indicate worse dysphagia-related quality of life To assess the impacts on quality of life on patients who have HPV positive SCC of the oropharynx who receive a reduction in CTV dose to 30 Gy as well as a reduction in CTV volumes, via the EORTC QLQ-C30 at baseline, week 7/EOT, 6 months, 12 months 18 months and 24 months following completion of radiation therapy.
Time frame
Baseline, at time of treatment completion, at 6-month intervals following treatment until 2 years after completion of RT3
Quality of life measured by EORTC QLQ-C30
European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30. t is a validated patient-reported outcome (PRO) instrument designed to assess health-related quality of life (HRQoL) in patients with cancer across clinical trials and routine practice. The transformed scale ranges from 0 - 100. Functional and Global Health scales: higher = better Symptom scales/items: higher = worse To assess the impacts on quality of life on patients who have HPV positive SCC of the oropharynx who receive a reduction in CTV dose to 30 Gy as well as a reduction in CTV volumes, via the EORTC QLQ-C30 at baseline, week 7/EOT, 6 months, 12 months 18 months and 24 months following completion of radiation therapy.
Time frame
Baseline, at time of treatment completion, at 6-month intervals following treatment until 2 years after completion of RTSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sara Medek
Lead sponsor
University of Cincinnati
Sponsor institution
Source ClinicalTrials.gov