De-escalation of treatment for HPV-related throat cancer
Phase II Trial of Surgery Followed by Risk-Directed Post-Operative Adjuvant Therapy for HPV-Related Oropharynx Squamous Cell Carcinoma: "The Minimalist Trial-2 (MINT-2)"
This study is testing a new way to treat HPV-related throat cancer that aims to use less intense therapy after surgery to lower side effects while still keeping the cancer under control.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 142 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT06702033 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates a de-escalation approach to treatment for patients with HPV-related oropharyngeal squamous cell carcinoma (OPSCC). Participants will undergo surgical resection of the tumor and regional lymph nodes, followed by varying levels of postoperative adjuvant therapy, including radiation and chemotherapy. The goal is to reduce treatment-related side effects while maintaining effective cancer control. Patients will be assigned to different treatment arms based on their pathology results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed HPV-related OPSCC at clinical stages I-II.
Not a fit: Patients with clinical T1N0M0 and T2N0M0 disease or those not meeting the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the morbidity associated with current treatment regimens for HPV-related OPSCC.
How similar studies have performed: Other studies have shown promise in de-escalation strategies for HPV-related cancers, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically or cytologically confirmed HPV-related, clinical stages I-II OPSCC (8th edition of AJCC/UICC Staging Manual) or HPV-related neck node with unknown primary. Clinical T1N0M0 and T2N0M0 disease are excluded. HPV-related may be defined by p16 IHC stain and/or HPV-High Risk RNA ISH/HPV DNA genotyping by PCR, using standard definitions of positive and negative test results. * Planned resection of the primary tumor site by a transoral approach (TORS, TLM, or conventional surgery). * Planned unilateral or contralateral selective neck dissection. * ECOG PS 0-2. * Adequate organ and marrow function defined as: * Creatinine clearance ≥ 50 mL/min. * ANC ≥ 1.0 K/cumm. * Platelet count ≥100 K/cumm. * 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. * Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants. Exclusion Criteria: * Clinical T1N0M0 or T2N0M0 disease. * Prior radiation therapy for HNSCC. * Planned free-flap reconstruction of the resected primary site. * Cirrhosis with Child-Pugh Score B or C. * 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 OS \> 90%) that were treated with curative-intent therapy. * 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 pregnancy test is required at screening for all female patients of childbearing potential.
Where this trial is running
St Louis, Missouri
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Douglas Adkins, M.D. — Washington University School of Medicine
- Study coordinator: Douglas Adkins, M.D.
- Email: dadkins@wustl.edu
- Phone: 314-747-8475
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.