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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months post-treatment (approximately 27 months)

Awards & highlights

MINT Trial 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.Check my eligibility

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.See study design

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.

MINT Trial 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.

MINT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months post-treatment (approximately 27 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months post-treatment (approximately 27 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months post-treatment (approximately 27 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean Percent Weight Change

Secondary outcome measures

Change in Serum Creatinine

Disease Recurrence Rate

Overall Survival (OS)

+3 more

Other outcome measures

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

MINT 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

~1940

Intensity modulated radiation therapy

2003

Completed Phase 2

~140

Surgery

2000

Completed Phase 3

~2550

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,931 Previous Clinical Trials

2,299,646 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the FDA recognize Neck Dissection Impairment Index as a legitimate medical tool?

"While there is some evidence that this procedure is safe, it remains unproven whether or not it is effective. Our team has given Neck Dissection Impairment Index a score of 2."

Answered by AI

Are patients still being enrolled in this research project?

"This particular clinical trial, as detailed on clinicaltrials.gov, is not currently looking for patients to enroll. The study was first made public on October 23rd 2018 but has not been updated since March 23rd 2022. Although this study isn't taking candidates right now, there are 3475 other trials that are still open to participants."

Answered by AI

Are there other existing research studies that measure the effects of Neck Dissection Impairment Index?

"As of now, there are 714 ongoing clinical trials researching Neck Dissection Impairment Index. Out of those, 284 are in Phase 3. Additionally, 43258 different locations worldwide are conducting research for Neck Dissection Impairment Index with several studies based out of Shanghai, China."

Answered by AI

What does the Neck Dissection Impairment Index help to diagnose?

"The Neck Dissection Impairment Index is a treatment that is most commonly used for advanced ovarian cancer. It can also be effective in treating refractory testicular cancer, and advance directives."

Answered by AI

How many research subjects will be taking part in this experiment?

"Currently, this trial is not recruiting. The clinical trial was first posted on October 23rd, 2018 and updated for the last time on March 23rd, 2022. However, there are 2761 trials actively enrolling patients with carcinoma and 714 studies searching for Neck Dissection Impairment Index patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Surgery Followed by Risk-Directed Post-Operative Adjuvant Therapy for HPV-Related Oropharynx Squamous Cell Carcinoma: "The Minimalist Trial (MINT)"

2018. "Surgery Followed by Risk-Directed Post-Operative Adjuvant Therapy for HPV-Related Oropharynx Squamous Cell Carcinoma: "The Minimalist Trial (MINT)"". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03621696.

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