NCT03621696|CompletedPhase 2ResultsDMCFDA Drug
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MINT
Phase II Trial of Surgery Followed by Risk-Directed Post-Operative Adjuvant Therapy for HPV-Related Oropharynx Squamous Cell Carcinoma: "The Minimalist Trial (MINT)"
Sponsor study identifier
interventional
63
1 country
1
Study Start
October 23, 2018
Actual (reported)Primary Completion
March 10, 2021
Actual (reported)Study Completion
March 17, 2026
Actual (reported)The overarching goal of the MINT trial is to reduce treatment-related toxicity while maintaining efficacy. Patients with HPV-related oropharyngeal squamous cell carcinoma (OPSCC) will undergo resection of the primary tumor site and involved/at risk regional neck nodes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 17, 2026
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 26, 2018
Actual (reported)August 8, 2018
Actual (reported)October 23, 2018
Actual (reported)March 10, 2021
Actual (reported)March 11, 2022
Actual (reported)March 17, 2026
Actual (reported)Mean Percent Weight Change
* Weight in kilograms will be collected weekly during radiation * The percent weight loss from the baseline is calculated at any post-baseline
Starting at Day 1 and ending on the last day of radiation therapy (approximately 4 weeks)
Proportion of PEG Tube Placements in Each Arm
Through completion of follow-up (approximately 63 months)
Change in Serum Creatinine
Baseline to 6 weeks after POAmCRT (approximately 90 days)
Percentage of Participants Taking Narcotics
6 weeks after POAmCRT (approximately 90 days)
Disease Recurrence Rate
24 months post-treatment (approximately 27 months)
Progression-free Survival (PFS)
Through completion of follow-up (approximately 63 months)
Comparison of Quality of Life as Measured by the Neck Dissection Impairment Index
From baseline through one year after completion of treatment (approximately 15 months)
Comparison of Quality of Life as Measured by the Scale of Subjective Total Taste Acuity
From baseline through one year after completion of treatment (approximately 15 months)
Comparison of Quality of Life as Measured by the University of Michigan Xerostomia Index
From baseline through one year after completion of treatment (approximately 15 months)
* Patients with extracapsular extension (ECE) or positive margin but not clinical or pathologic T4 or clinical N3 disease * Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes * Treated with post-operative adjuvant modified chemoradiation therapy (POAmCRT) which is 42 Gy radiation therapy in 21 doses and 1 dose of cisplatin. * It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection * Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study
-100 mg/m\^2 intravenous push bolus (IVPB)
-IMRT or IMPT can be used
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Douglas Adkins, M.D.
Washington University School of Medicine
63 participants (actual enrollment reported by the registry).
First Submitted
July 26, 2018
First Posted
August 8, 2018
Study Start
October 23, 2018
Actual (reported)* Patients with no extracapsular extension (ECE) and no positive margins and not clinical or pathologic T4 or clinical N3 disease * Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes * Treated with post-operative adjuvant modified radiation therapy (POAmRT) which is 42 Gy radiation therapy in 21 doses * It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection * Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study
* Patients with clinical or pathologic T4 or clinical N3 disease * Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes * Treated with post-operative adjuvant chemoradiation therapy (POACRT) which is 60 Gy radiation therapy in 30 doses and 3 doses of cisplatin (if there is pathologic evidence of ECE or positive margins) * The first dose of cisplatin will given on one of the days during the initial 5 days of radiation therapy, the 2nd dose on the day of radiation dose 16, and the 3rd dose on the day of radiation dose 26. * It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection * Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study
-IMRT or IMPT can be used
-Standard of care
-Baseline, interim assessment (14-42 days post-surgery), day 1 of radiation, day 21 of radiation, day 36 of radiation, 6 weeks after completion of adjuvant therapy, 4 months after the completion of adjuvant therapy, 6 months after the completion of adjuvant therapy, 12 months after the completion of adjuvant therapy, and 24 months after completion of adjuvant therapy
-Baseline, interim assessment (14-42 days post-surgery), day 1 of radiation, day 21 of radiation, day 36 of radiation, 6 weeks after completion of adjuvant therapy, 4 months after the completion of adjuvant therapy, 6 months after the completion of adjuvant therapy, 12 months after the completion of adjuvant therapy, and 24 months after completion of adjuvant therapy
-Baseline, interim assessment (14-42 days post-surgery), day 1 of radiation, day 21 of radiation, day 36 of radiation, 6 weeks after completion of adjuvant therapy, 4 months after the completion of adjuvant therapy, 6 months after the completion of adjuvant therapy, 12 months after the completion of adjuvant therapy, and 24 months after completion of adjuvant therapy
-Baseline, interim assessment (14-42 days post-surgery), day 1 of radiation, day 21 of radiation, day 36 of radiation, 6 weeks after completion of adjuvant therapy, 4 months after the completion of adjuvant therapy, 6 months after the completion of adjuvant therapy, 12 months after the completion of adjuvant therapy, and 24 months after completion of adjuvant therapy
-Baseline, interim assessment (14-42 days post-surgery), day 1 of radiation, day 21 of radiation, day 36 of radiation, 6 weeks after completion of adjuvant therapy, 4 months after the completion of adjuvant therapy, 6 months after the completion of adjuvant therapy, 12 months after the completion of adjuvant therapy, and 24 months after completion of adjuvant therapy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
March 10, 2021
Actual (reported)Study Completion
March 17, 2026
Actual (reported)Last Updated
April 21, 2026
Results First Posted
March 11, 2022
Record last verified: 2026-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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