Surgery Followed by Risk-Directed Post-Operative Adjuvant Therapy for HPV-Related Oropharynx Squamous Cell Carcinoma: "The Minimalist Trial (MINT)"
Condition: HPV Related Oropharyngeal Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Cisplatin; Intensity modulated radiation therapy; Intensity modulated proton therapy; Surgery; FACT-H&N; MD Anderson Dysphagia Inventory; University of Michigan Xerostomia Index; Scale of Subjective Total Taste Acuity; Neck Dissection Impairment Index
Intervention description: -100 mg/m^2 intravenous push bolus (IVPB); -IMRT or IMPT can be used; -IMRT or IMPT can be used; -Standard of care; -Baseline, interim assessment (14-42 days post-surgery), day 1 of radiation, day 21 of radiation, day 36 of radiation, 6 weeks after completion of adjuvant therapy, 4 months after the completion of adjuvant therapy, 6 months after the completion of adjuvant therapy, 12 months after the completion of adjuvant therapy, and 24 months after completion of adjuvant therapy; -Baseline, interim assessment (14-42 days post-surgery), day 1 of radiation, day 21 of radiation, day 36 of radiation, 6 weeks after completion of adjuvant therapy, 4 months after the completion of adjuvant therapy, 6 months after the completion of adjuvant therapy, 12 months after the completion of adjuvant therapy, and 24 months after completion of adjuvant therapy; -Baseline, interim assessment (14-42 days post-surgery), day 1 of radiation, day 21 of radiation, day 36 of radiation, 6 weeks after completion of adjuvant therapy, 4 months after the completion of adjuvant therapy, 6 months after the completion of adjuvant therapy, 12 months after the completion of adjuvant therapy, and 24 months after completion of adjuvant therapy; -Baseline, interim assessment (14-42 days post-surgery), day 1 of radiation, day 21 of radiation, day 36 of radiation, 6 weeks after completion of adjuvant therapy, 4 months after the completion of adjuvant therapy, 6 months after the completion of adjuvant therapy, 12 months after the completion of adjuvant therapy, and 24 months after completion of adjuvant therapy; -Baseline, interim assessment (14-42 days post-surgery), day 1 of radiation, day 21 of radiation, day 36 of radiation, 6 weeks after completion of adjuvant therapy, 4 months after the completion of adjuvant therapy, 6 months after the completion of adjuvant therapy, 12 months after the completion of adjuvant therapy, and 24 months after completion of adjuvant therapy
Intervention MeSH terms: Cisplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.