Clinical trial NCT03621696: Surgery Followed by Risk-Directed Post-Operative Adjuvant Therapy for HPV-Related Oropharynx Squamous Cell Carcinoma: "The Minimalist Trial (MINT)"
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 (MINT)"
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: HPV Related Oropharyngeal Squamous Cell Carcinoma
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Mean Percent Weight Change
timeFrame: Starting at Day 1 and ending on the last day of radiation therapy (approximately 4 weeks)
Secondary outcomes:
measure: Proportion of PEG Tube Placements in Each Arm
timeFrame: Through completion of follow-up (approximately 63 months)
measure: Change in Serum Creatinine
timeFrame: Baseline to 6 weeks after POAmCRT (approximately 90 days)
measure: Percentage of Participants Taking Narcotics
timeFrame: 6 weeks after POAmCRT (approximately 90 days)
measure: Disease Recurrence Rate
timeFrame: 24 months post-treatment (approximately 27 months)
measure: Progression-free Survival (PFS)
timeFrame: Through completion of follow-up (approximately 63 months)
measure: Overall Survival (OS)
timeFrame: Through completion of follow-up (approximately 63 months)
Other outcomes:
measure: Comparison of Quality of Life as Measured by the Neck Dissection Impairment Index
timeFrame: From baseline through one year after completion of treatment (approximately 15 months)
measure: Comparison of Quality of Life as Measured by the Scale of Subjective Total Taste Acuity
timeFrame: From baseline through one year after completion of treatment (approximately 15 months)
measure: Comparison of Quality of Life as Measured by the University of Michigan Xerostomia Index
timeFrame: From baseline through one year after completion of treatment (approximately 15 months)
measure: Comparison of Quality of Life as Measured by the MD Anderson Dysphagia Inventory
timeFrame: From baseline through one year after completion of treatment (approximately 15 months)
measure: Comparison of Quality of Life as Measured by the FACT-H&N
timeFrame: From baseline through one year after completion of treatment (approximately 15 months)
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Douglas Adkins, M.D.
role: PRINCIPAL_INVESTIGATOR
References: