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Completed

NCT Number: NCT03621696

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Cisplatin

Drug

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

Other names: Platinol®, Platinol-AQ®

Intensity modulated radiation therapy

Radiation

-IMRT or IMPT can be used

Other names: IMRT

Intensity modulated proton therapy

Radiation

-IMRT or IMPT can be used

Other names: IMPT

Surgery

Procedure

-Standard of care

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

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

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

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

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

Primary outcomes

  1. Mean Percent Weight Change

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

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

Secondary outcomes

  1. Proportion of PEG Tube Placements in Each Arm

    Time frame: Through completion of follow-up (approximately 63 months)

    -95% confidence intervals will be calculated assuming a binomial distribution

  2. Change in Serum Creatinine

    Time frame: Baseline to 6 weeks after POAmCRT (approximately 90 days)

  3. Percentage of Participants Taking Narcotics

    Time frame: 6 weeks after POAmCRT (approximately 90 days)

    -95% confidence intervals will be calculated assuming a binomial distribution

  4. Disease Recurrence Rate

    Time frame: 24 months post-treatment (approximately 27 months)

  5. Progression-free Survival (PFS)

    Time frame: Through completion of follow-up (approximately 63 months)

  6. Overall Survival (OS)

    Time frame: Through completion of follow-up (approximately 63 months)

Other outcomes

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

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

    -10-item self-administered questionnaire, which was designed to assess "quality of life related to shoulder dysfunction" after neck dissection. A 5-point response option (1 to 5) is provided for each item, with 1 being the most disability and 5 the least disability. The responses for all 10 items are added together to produce a raw score, which is then transformed to a score of 100 maximum. Higher scores represent less disability.

    --Captured at baseline, interim assessment (14-42 days post-surgery), Day 1 of radiation, Day 21 after start of radiation, Day 36 after start of radiation, and 6 weeks/4 months/6 months/12 months after completion of adjuvant therapy

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

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

    -Measures total taste acuity with the patient choosing the appropriate answer ranging from 0=same taste acuity as before treatment to 4=almost complete or complete loss of taste acuity

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

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

    • Measures impact of salivary gland dysfunction & xerostomia. Scale consists of 15 items covering 4 major domains of oral health-related quality of life: physical functioning, personal/psychological functioning, social functioning, & pain/discomfort issues
    • Patients answer the questions by checking the box that describes the best statement for the past 7 days (not at all, a little, somewhat, quite a bit, very much), 1-5 scale. Higher scores represent greater degree of symptoms. Physical functioning based upon responses to items 1, 6, 10, 12. Pain/discomfort issues based upon responses to items 2, 3, 7, 9. Personal/psychological functioning based upon responses to items 8, 13, 14, 15. Social functioning based upon responses to items 4, 5, 11
    • Captured at baseline, interim assessment (14-42 days post-surgery), Day 1 of radiation, Day 21 after start of radiation, Day 36 after start of radiation, & 6 weeks/4 months/6 months/12 months after completion of adjuvant therapy
  4. Comparison of Quality of Life as Measured by the MD Anderson Dysphagia Inventory

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

    • Consists of 20 items. Besides a global assessment (a single question), it comprises three subscales: the emotional subscale (8 items), the functional subscale (5 items), and the physical subscale (6 items). The global assessment refers to the individual's swallowing difficulty as it affects one's overall daily routine. The emotional, functional, and physical subscales refer to the individual's affective response to the swallowing disorder, the impact of the disorder on daily activities, and the self-perception of the swallowing difficulties, respectively. Using a five-point scale (1-5), the minimum total score is 20 and the maximum 100
    • Captured at baseline, interim assessment (14-42 days post-surgery), Day 1 of radiation, Day 21 after start of radiation, Day 36 after start of radiation, and 6 weeks/4 months/6 months/12 months after completion of adjuvant therapy
  5. Comparison of Quality of Life as Measured by the FACT-H&N

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

    • Consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for head and neck related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce subscale scores for each domain, as well as an global QoL score. Higher scores represent better QoL.
    • Captured at baseline, interim assessment (14-42 days post-surgery), Day 1 of radiation, Day 21 after start of radiation, Day 36 after start of radiation, and 6 weeks/4 months/6 months/12 months after completion of adjuvant therapy

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Acronym: MINT

Important dates

Study start
2018
Primary completion
2021
Study completion
2026
First posted
Aug 8, 2018
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.