Phase 2
Completed N=63
Surgery Followed by Risk-Directed Post-Operative Adjuvant Therapy for HPV-Related Oropharynx Squamous Cell Carcinoma: "The Minimalist Trial (MINT)"
Source: ClinicalTrials.gov NCT03621696 ↗Enrolled (actual)
63
Serious AEs
12.1%
Results posted
Mar 2022
Primary outcomePrimary: Mean Percent Weight Change — -4.89; -3.18; -10.11 percent of change
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Weight Change |
-4.89; -3.18; -10.11 | — |
| SECONDARY Proportion of PEG Tube Placements in Each Arm |
— | — |
| SECONDARY Change in Serum Creatinine |
0.03; 0.08; -0.19 | — |
| SECONDARY Percentage of Participants Taking Narcotics |
40; 20; 75 | — |
| SECONDARY Disease Recurrence Rate |
2; 1; 3 | — |
| SECONDARY Progression-free Survival (PFS) |
— | — |
| SECONDARY Overall Survival (OS) |
— | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03621696). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.