RECRUITING

The Minimalist Trial-2

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Conditions

HPV-Related Oropharynx Squamous Cell CarcinomaDe-escalationAdjuvant therapyOropharyngeal cancerHuman papillomavirus

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Head and neck squamous cell carcinoma (HNSCC) is the sixth most common cancer. Oropharynx SCC (OPSCC) is a common sub-type of HNSCC. Each year, 16,000 new cases of OPSCC are diagnosed in the USA. Most cases of OPSCC (\>90%) are caused by the human papillomavirus (HPV) and are often cured with current therapy. However, patients treated with surgery followed by postoperative adjuvant chemotherapy and radiation therapy (POA(C)RT) still experience substantial morbidity. In this highly curable disease, current clinical research interest is focused on investigation of de-escalated therapy, with the goal to reduce treatment-related adverse events (AEs) while maintaining a low recurrence rate. In this study, patients with HPV-related OPSCC will undergo resection of the primary tumor site and involved/at-risk regional neck nodes. Based on the pathology report, patients will be assigned to: * Arm 1 (de-POACRT-42 Gy) * Arm 2A (de-POART-42 Gy) * Arm 2B (de-POART-37.8 Gy) * Arm 2C (de-POACRT-30 Gy). All patients with high-risk pathology will be assigned to Arm 1 whereas patients with intermediate-risk pathology will be randomized (1:1:1) to Arm 2A, Arm 2B, or Arm 2C. Patients with highest-risk pathology and low-risk pathology will be removed from the trial after surgery and will be advised to pursue standard of care options.

Official Title

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)"

Quick Facts

Study Start:2025-04-10
Study Completion:2033-07-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06702033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Planned resection of the primary tumor site by a transoral approach (TORS, TLM, or conventional surgery).
  3. * Planned unilateral or contralateral selective neck dissection.
  4. * ECOG PS 0-2.
  5. * Adequate organ and marrow function defined as:
  6. * Creatinine clearance ≥ 50 mL/min.
  7. * ANC ≥ 1.0 K/cumm.
  8. * Platelet count ≥100 K/cumm.
  9. * At least 18 years of age.
  10. * 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.
  11. * 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.
  1. * Clinical T1N0M0 or T2N0M0 disease.
  2. * Prior radiation therapy for HNSCC.
  3. * Planned free-flap reconstruction of the resected primary site.
  4. * Cirrhosis with Child-Pugh Score B or C.
  5. * 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.
  6. * Receiving any other investigational agents.
  7. * Uncontrolled serious inter-current illness or serious psychiatric illness/social situations that would limit compliance with study requirements.
  8. * Pregnant and/or breastfeeding. A negative serum pregnancy test is required at screening for all female patients of childbearing potential.

Contacts and Locations

Study Contact

Douglas Adkins, M.D.
CONTACT
314-747-8475
dadkins@wustl.edu

Principal Investigator

Douglas Adkins, M.D.
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine

Study Locations (Sites)

Washington University School of Medicine
Saint Louis, Missouri, 63110
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

  • Douglas Adkins, M.D., PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-10
Study Completion Date2033-07-15

Study Record Updates

Study Start Date2025-04-10
Study Completion Date2033-07-15

Terms related to this study

Keywords Provided by Researchers

  • De-escalation
  • Adjuvant therapy
  • Oropharyngeal cancer
  • Human papillomavirus

Additional Relevant MeSH Terms

  • HPV-Related Oropharynx Squamous Cell Carcinoma