HPV Related Oropharyngeal Squamous Cell Carcinoma Clinical Trial
— MINTOfficial 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)"
| Verified date | October 2023 |
| Source | Washington University School of Medicine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 63 |
| Est. completion date | March 10, 2026 |
| Est. primary completion date | March 10, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| Washington University School of Medicine |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Comparison of Quality of Life as Measured by the Neck Dissection Impairment Index | -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 |
From baseline through one year after completion of treatment (approximately 15 months) | |
| Other | Comparison of Quality of Life as Measured by the Scale of Subjective Total Taste Acuity | -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 | From baseline through one year after completion of treatment (approximately 15 months) | |
| Other | Comparison of Quality of Life as Measured by the University of Michigan Xerostomia Index | 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 |
From baseline through one year after completion of treatment (approximately 15 months) | |
| Other | Comparison of Quality of Life as Measured by the MD Anderson Dysphagia Inventory | 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 |
From baseline through one year after completion of treatment (approximately 15 months) | |
| Other | Comparison of Quality of Life as Measured by the FACT-H&N | 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 |
From baseline through one year after completion of treatment (approximately 15 months) | |
| Primary | 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 | Proportion of PEG Tube Placements in Each Arm | -95% confidence intervals will be calculated assuming a binomial distribution | Through completion of follow-up (approximately 63 months) | |
| Secondary | Change in Serum Creatinine | Baseline to 6 weeks after POAmCRT (approximately 90 days) | ||
| Secondary | Percentage of Participants Taking Narcotics | -95% confidence intervals will be calculated assuming a binomial distribution | 6 weeks after POAmCRT (approximately 90 days) | |
| Secondary | Disease Recurrence Rate | 24 months post-treatment (approximately 27 months) | ||
| Secondary | Progression-free Survival (PFS) | Through completion of follow-up (approximately 63 months) | ||
| Secondary | Overall Survival (OS) | Through completion of follow-up (approximately 63 months) |