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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through completion of follow-up (approximately 63 months)

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~3120

Intensity modulated radiation therapy

2003

Completed Phase 2

~140