Sponsor study identifier
interventional
142
1 country
3
Study Start
April 10, 2025
Actual (reported)Primary Completion
April 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 15, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Head and neck squamous cell carcinoma (HNSCC) is the sixth most common cancer. Oropharynx SCC (OPSCC) is a common sub-type of HNSCC. Each year, 16,000 new cases of OPSCC are diagnosed in the USA. Most cases of OPSCC (\>90%) are caused by the human papillomavirus (HPV) and are often cured with current therapy. However, patients treated with surgery followed by postoperative adjuvant chemotherapy and radiation therapy (POA(C)RT) still experience substantial morbidity. In this highly curable disease, current clinical research interest is focused on investigation of de-escalated therapy, with the goal to reduce treatment-related adverse events (AEs) while maintaining a low recurrence rate. In this study, patients with HPV-related OPSCC will undergo resection of the primary tumor site and involved/at-risk regional neck nodes. Based on the pathology report, patients will be assigned to:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 15, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 19, 2024
Actual (reported)November 22, 2024
Actual (reported)April 10, 2025
Actual (reported)April 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 15, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Recurrence rate
At 2 years
Percent weight loss
From start of radiation therapy to completion of radiation therapy (estimated to be 6 weeks)
Proportion of patients undergoing PEG tube placement
Through completion of follow-up (estimated to be 5 years and 10 weeks)
Duration of need for an indwelling PEG tube
Through completion of follow-up (estimated to be 5 years and 10 weeks)
Proportion of patients taking narcotic
Through completion of follow-up (estimated to be 5 years and 10 weeks)
Number of participants with adverse events
From start of surgery through 24-month follow-up visit (estimated to be 2 years and 10 weeks)
* Standard of care surgery will occur before adjuvant therapy. * It is recommended that radiation therapy begin within 28 to 49 days (and no later than 56 days). * The total dose to the postoperative tumor bed will be 4200 cGy in 21 fractions of 200 cGy each over 4 weeks. * Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 3780 cGy in 21 fractions of 180 cGy each. * Cisplatin will be given on the same day as one of the initial 5 doses of radiation therapy.
* Standard of care surgery will occur before adjuvant therapy. * It is recommended that radiation therapy begin within 28 to 49 days (and no later than 56 days). * The total dose to the postoperative tumor bed will be 4200 cGy in 21 fractions of 200 cGy each over 4 weeks. * Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 3780 cGy in 21 fractions of 180 cGy each.
IMRT or IMPT
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Douglas Adkins, M.D.
Washington University School of Medicine
First Submitted
November 19, 2024
First Posted
November 22, 2024
Study Start
April 10, 2025
Actual (reported)Primary Completion
* Standard of care surgery will occur before adjuvant therapy. * It is recommended that radiation therapy begin within 28 to 49 days (and no later than 56 days). * The total dose to the postoperative tumor bed will be 3780 cGY in 21 fractions of 180 cGy each over 4 weeks. * Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 3360 cGy in 21 fractions of 160 cGy each.
* Standard of care surgery will occur before adjuvant therapy. * It is recommended that radiation therapy begin within 28 to 49 days (and no later than 56 days). * The total dose to the postoperative tumor bed will be 3000 cGy in 15 fractions of 200 cGy over 3 weeks. * Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 2700 cGy in 15 fractions of 180 cGy each. * Cisplatin will be given on the same day as one of the initial 5 doses of radiation therapy.
Dose of 100 mg/m\^2 IVPB over 60 minutes
Standard of care
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Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58102, United States
Sanford Cancer Center
Sioux Falls, South Dakota, 57104, United States
April 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 15, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 24, 2026
Record last verified: 2026-07
Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices), and the study protocol will be shared, beginning 9 months and ending 24 months following article publication, with investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. Types of acceptable analyses include approved proposal(s) or individual participant data for meta-analyses.
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Source: ClinicalTrials.gov.
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