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

Recruiting in Palo Alto (17 mi)

Overseen byDouglas R. Adkins

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

My cancer is HPV-related and in stages I-III or is in the neck node with an unknown primary source.

My tumor will be removed through my mouth.

+4 more

Exclusion Criteria

I was diagnosed with another cancer besides the one being studied within the last 2 years.

I have had treatment aimed at curing head and neck cancer.

My cancer has spread to distant parts of my body.

+3 more

Participant Groups

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.

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