Washington University School of Medicine
St Louis, Missouri, 63110, United States
NCT Number: NCT03621696
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
St Louis, Missouri, 63110, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-100 mg/m^2 intravenous push bolus (IVPB)
Other names: Platinol®, Platinol-AQ®
-IMRT or IMPT can be used
Other names: IMRT
-IMRT or IMPT can be used
Other names: IMPT
-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
Time frame: Starting at Day 1 and ending on the last day of radiation therapy (approximately 4 weeks)
Time frame: Through completion of follow-up (approximately 63 months)
-95% confidence intervals will be calculated assuming a binomial distribution
Time frame: Baseline to 6 weeks after POAmCRT (approximately 90 days)
Time frame: 6 weeks after POAmCRT (approximately 90 days)
-95% confidence intervals will be calculated assuming a binomial distribution
Time frame: 24 months post-treatment (approximately 27 months)
Time frame: Through completion of follow-up (approximately 63 months)
Time frame: Through completion of follow-up (approximately 63 months)
Time frame: From baseline through one year after completion of treatment (approximately 15 months)
-10-item self-administered questionnaire, which was designed to assess "quality of life related to shoulder dysfunction" after neck dissection. A 5-point response option (1 to 5) is provided for each item, with 1 being the most disability and 5 the least disability. The responses for all 10 items are added together to produce a raw score, which is then transformed to a score of 100 maximum. Higher scores represent less disability.
--Captured at baseline, interim assessment (14-42 days post-surgery), Day 1 of radiation, Day 21 after start of radiation, Day 36 after start of radiation, and 6 weeks/4 months/6 months/12 months after completion of adjuvant therapy
Time frame: From baseline through one year after completion of treatment (approximately 15 months)
-Measures total taste acuity with the patient choosing the appropriate answer ranging from 0=same taste acuity as before treatment to 4=almost complete or complete loss of taste acuity
Time frame: From baseline through one year after completion of treatment (approximately 15 months)
Time frame: From baseline through one year after completion of treatment (approximately 15 months)
Time frame: From baseline through one year after completion of treatment (approximately 15 months)
Washington University School of Medicine
Other
Phase II Trial of Surgery Followed by Risk-Directed Post-Operative Adjuvant Therapy for HPV-Related Oropharynx Squamous Cell Carcinoma: "The Minimalist Trial (MINT)"
Acronym: MINT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.