Surgery Followed by Risk-Directed Post-Operative Adjuvant Therapy for HPV-Related Oropharynx Squamous Cell Carcinoma: "The Minimalist Trial (MINT)"

The Washington University

Status and phase

Active, not recruiting

Phase 2

Conditions

HPV Related Oropharyngeal Squamous Cell Carcinoma

Treatments

Other: Scale of Subjective Total Taste Acuity

Radiation: Intensity modulated radiation therapy

Procedure: Surgery

Other: University of Michigan Xerostomia Index

Other: FACT-H&N

Other: Neck Dissection Impairment Index

Radiation: Intensity modulated proton therapy

Other: MD Anderson Dysphagia Inventory

Drug: Cisplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT03621696

201808045

Details and patient eligibility

About

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.

Enrollment

63 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

63 participants in 3 patient groups

Arm 1: POAmCRT

Experimental group

Description:

* Patients with extracapsular extension (ECE) or positive margin but not clinical or pathologic T4 or clinical N3 disease * Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes * Treated with post-operative adjuvant modified chemoradiation therapy (POAmCRT) which is 42 Gy radiation therapy in 21 doses and 1 dose of cisplatin. * It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection * Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study

Treatment:

Drug: Cisplatin

Other: MD Anderson Dysphagia Inventory

Other: Neck Dissection Impairment Index

Radiation: Intensity modulated proton therapy

Other: University of Michigan Xerostomia Index

Other: FACT-H&N

Procedure: Surgery

Radiation: Intensity modulated radiation therapy

Other: Scale of Subjective Total Taste Acuity

Arm 2: POAmRT

Experimental group

Description:

* Patients with no extracapsular extension (ECE) and no positive margins and not clinical or pathologic T4 or clinical N3 disease * Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes * Treated with post-operative adjuvant modified radiation therapy (POAmRT) which is 42 Gy radiation therapy in 21 doses * It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection * Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study

Treatment:

Other: MD Anderson Dysphagia Inventory

Other: Neck Dissection Impairment Index

Radiation: Intensity modulated proton therapy

Other: University of Michigan Xerostomia Index

Other: FACT-H&N

Procedure: Surgery

Radiation: Intensity modulated radiation therapy

Other: Scale of Subjective Total Taste Acuity

Arm 3: POACRT

Experimental group

Description:

* Patients with clinical or pathologic T4 or clinical N3 disease * Standard of care surgery (surgical resection of the primary tumor via a transoral approach and surgical management of cervical lymph nodes * Treated with post-operative adjuvant chemoradiation therapy (POACRT) which is 60 Gy radiation therapy in 30 doses and 3 doses of cisplatin (if there is pathologic evidence of ECE or positive margins) * The first dose of cisplatin will given on one of the days during the initial 5 days of radiation therapy, the 2nd dose on the day of radiation dose 16, and the 3rd dose on the day of radiation dose 26. * It is recommended that radiation therapy begin within 28-49 days (no later than 56 days) after surgical resection * Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) is to be used for this study

Treatment:

Drug: Cisplatin

Other: MD Anderson Dysphagia Inventory

Other: Neck Dissection Impairment Index

Radiation: Intensity modulated proton therapy

Other: University of Michigan Xerostomia Index

Other: FACT-H&N

Procedure: Surgery

Radiation: Intensity modulated radiation therapy

Other: Scale of Subjective Total Taste Acuity

Trial documents