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Risk-Directed Therapy After Surgery for Throat Cancer (MINT Trial)

Phase 2
Waitlist Available
Led By Douglas Adkins, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2
Histologically or cytologically confirmed HPV-related stages I-III OPSCC or HPV-related neck node with unknown primary
Must not have
Prior curative therapy for HNSCC
Known distant metastatic disease at presentation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of follow-up (approximately 63 months)
Awards & highlights

Summary

This trial is testing a new treatment for HPV-related throat cancer that they hope will be less toxic while still being effective.

Who is the study for?
The MINT trial is for adults with HPV-related oropharyngeal squamous cell carcinoma stages I-III, who can undergo surgery via a transoral approach. Participants must have proper kidney function, no recent invasive cancers (with some exceptions), and not be pregnant. They should agree to use contraception and have an ECOG Performance Status of 0-2.
What is being tested?
This trial tests post-operative therapy tailored to individual risk after surgical tumor removal in patients with HPV-related oral cancer. It aims to minimize treatment side effects while maintaining effectiveness, using various assessments and therapies including Cisplatin and radiation.
What are the potential side effects?
Potential side effects may include difficulty swallowing, changes in taste perception, dry mouth symptoms, neck mobility issues due to surgery or radiation therapy, as well as typical chemotherapy-associated risks like fatigue and nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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My cancer is HPV-related and in stages I-III or is in the neck node with an unknown primary source.
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My tumor will be removed through my mouth.
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My kidney function, white blood cell count, and platelet count are all within normal ranges.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had treatment aimed at curing head and neck cancer.
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My cancer has spread to distant parts of my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of follow-up (approximately 63 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of follow-up (approximately 63 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Percent Weight Change
Secondary study objectives
Percentage of Participants Taking Narcotics
Proportion of PEG Tube Placements in Each Arm
Other study objectives
Comparison of Quality of Life as Measured by the FACT-H&N
Comparison of Quality of Life as Measured by the MD Anderson Dysphagia Inventory
Neck
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm 3: POACRTExperimental Treatment9 Interventions
* 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
Group II: Arm 2: POAmRTExperimental Treatment8 Interventions
* 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
Group III: Arm 1: POAmCRTExperimental Treatment9 Interventions
* 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~2360
Intensity modulated radiation therapy
2003
Completed Phase 2
~140
Surgery
2000
Completed Phase 3
~2490

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,970 Previous Clinical Trials
2,308,560 Total Patients Enrolled
Douglas Adkins, M.D.Principal InvestigatorWashington University School of Medicine
11 Previous Clinical Trials
500 Total Patients Enrolled

Media Library

Surgery Clinical Trial Eligibility Overview. Trial Name: NCT03621696 — Phase 2
Oropharyngeal Carcinoma Research Study Groups: Arm 1: POAmCRT, Arm 2: POAmRT, Arm 3: POACRT
Oropharyngeal Carcinoma Clinical Trial 2023: Surgery Highlights & Side Effects. Trial Name: NCT03621696 — Phase 2
Surgery 2023 Treatment Timeline for Medical Study. Trial Name: NCT03621696 — Phase 2
~9 spots leftby Sep 2025
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