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

NCT03621696 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 201808045
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HPV Related Oropharyngeal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Mean Percent Weight Change

  * Weight in kilograms will be collected weekly during radiation * The percent weight loss from the baseline is calculated at any post-baseline

  Starting at Day 1 and ending on the last day of radiation therapy (approximately 4 weeks)

Secondary Outcomes (6)

• Proportion of PEG Tube Placements in Each Arm

  Through completion of follow-up (approximately 63 months)

• Change in Serum Creatinine

  Baseline to 6 weeks after POAmCRT (approximately 90 days)

• Percentage of Participants Taking Narcotics

  6 weeks after POAmCRT (approximately 90 days)

• Disease Recurrence Rate

  24 months post-treatment (approximately 27 months)

• Progression-free Survival (PFS)

  Through completion of follow-up (approximately 63 months)

Other Outcomes (5)

• Comparison of Quality of Life as Measured by the Neck Dissection Impairment Index

  From baseline through one year after completion of treatment (approximately 15 months)

• Comparison of Quality of Life as Measured by the Scale of Subjective Total Taste Acuity

  From baseline through one year after completion of treatment (approximately 15 months)

• Comparison of Quality of Life as Measured by the University of Michigan Xerostomia Index

  From baseline through one year after completion of treatment (approximately 15 months)

Study Arms (3)

Arm 1: POAmCRT

EXPERIMENTAL

* 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

Drug: Cisplatin; Radiation: Intensity modulated radiation therapy; Radiation: Intensity modulated proton therapy; Procedure: Surgery; Other: FACT-H&N; Other: MD Anderson Dysphagia Inventory; Other: University of Michigan Xerostomia Index; Other: Scale of Subjective Total Taste Acuity; Other: Neck Dissection Impairment Index

Arm 2: POAmRT

EXPERIMENTAL

* 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

Radiation: Intensity modulated radiation therapy; Radiation: Intensity modulated proton therapy; Procedure: Surgery; Other: FACT-H&N; Other: MD Anderson Dysphagia Inventory; Other: University of Michigan Xerostomia Index; Other: Scale of Subjective Total Taste Acuity; Other: Neck Dissection Impairment Index

Arm 3: POACRT

EXPERIMENTAL

* 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

Drug: Cisplatin; Radiation: Intensity modulated radiation therapy; Radiation: Intensity modulated proton therapy; Procedure: Surgery; Other: FACT-H&N; Other: MD Anderson Dysphagia Inventory; Other: University of Michigan Xerostomia Index; Other: Scale of Subjective Total Taste Acuity; Other: Neck Dissection Impairment Index

Interventions

Cisplatin DRUG

-100 mg/m\^2 intravenous push bolus (IVPB)

Also known as: Platinol®, Platinol-AQ®

Arm 1: POAmCRT; Arm 3: POACRT

Intensity modulated radiation therapy RADIATION

-IMRT or IMPT can be used

Also known as: IMRT

Arm 1: POAmCRT; Arm 2: POAmRT; Arm 3: POACRT

Intensity modulated proton therapy RADIATION

-IMRT or IMPT can be used

Also known as: IMPT

Arm 1: POAmCRT; Arm 2: POAmRT; Arm 3: POACRT

Surgery PROCEDURE

-Standard of care

Arm 1: POAmCRT; Arm 2: POAmRT; Arm 3: POACRT

FACT-H&N OTHER

-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

Arm 1: POAmCRT; Arm 2: POAmRT; Arm 3: POACRT

MD Anderson Dysphagia Inventory OTHER

-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

Arm 1: POAmCRT; Arm 2: POAmRT; Arm 3: POACRT

University of Michigan Xerostomia Index OTHER

-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

Arm 1: POAmCRT; Arm 2: POAmRT; Arm 3: POACRT

Scale of Subjective Total Taste Acuity OTHER

-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

Arm 1: POAmCRT; Arm 2: POAmRT; Arm 3: POACRT

Neck Dissection Impairment Index OTHER

-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

Arm 1: POAmCRT; Arm 2: POAmRT; Arm 3: POACRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed HPV-related stages I-III OPSCC (8th edition of AJCC/UICC Staging Manual) or HPV-related neck node with unknown primary. HPV-related may be defined by p16 IHC stain and/or HPV-ISH or PCR using standard definitions of positive and negative test results.
• Primary tumor that will be resected via a transoral oral approach (conventional surgery, transoral laser microsurgery, transoral robotic surgery)
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2.
• Normal organ and marrow function defined as:
• Creatinine clearance \> 50 cc/min.
• ANC \> 1,000/mcL.
• Platelet count \>100,000/mcL.
• At least 18 years of age.
• Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
• Patient (or legally authorized representative) must be able to understand and willing to sign a written informed consent document.

You may not qualify if:

• Prior curative therapy for HNSCC.
• Patient must not have known distant metastatic disease at presentation.
• History of prior invasive malignancy diagnosed within 2 years prior to study enrollment; exceptions are malignancies with a low risk of metastasis or death (e.g., expected 5-year overall survival (OS) \> 90%) that were treated with an expected curative outcome, such as squamous cell carcinoma of the skin, in-situ carcinoma of the cervix uteri, non-melanomatous skin cancer, carcinoma in situ of the breast, or incidental histological finding of prostate cancer (TNM stage of T1a or T1b).
• Receiving any other investigational agents.
• Uncontrolled serious inter-current illness or serious psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant and/or breastfeeding. A negative serum or urine pregnancy test is required at screening for all female patients of childbearing potential.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Interventions

Cisplatin; Radiotherapy, Intensity-Modulated; Surgical Procedures, Operative

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Douglas Adkins, M.D.
• Organization: Washington University School of Medicine

dadkins@wustl.edu

314-747-8475

Study Officials

• Douglas Adkins, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 8, 2018
• Study Start: October 23, 2018
• Primary Completion: March 10, 2021
• Study Completion: March 17, 2026
• Last Updated: April 21, 2026
• Results First Posted: March 11, 2022

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)