Swallowing Outcomes and Circulating Tumor DNA in Patients With HPV Related Oropharyngeal Cancer Treated With Transoral Surgery and Reduced Intensity Adjuvant Therapy

Summary

This is a non-randomized, open-label phase II clinical trial that studies the effect of reduced dose radiation therapy and chemotherapy after surgery in treating patients with human papillomavirus (HPV) caused throat cancer. Giving reduced dose radiation therapy and chemotherapy after surgery may improve quality of life compared with standard of care primary chemoradiation approach without compromising survival.

Conditions

• Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
• Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
• Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
• Oropharyngeal Human Papillomavirus-Positive Squamous Cell Carcinoma

Interventions

PROCEDURE

Transoral Surgery

Patients will undergo transoral surgery

RADIATION

External Beam Radiation Therapy

Patients in Group II and Group III will undergo External Beam Radiation Therapy (EBRT) RT following transoral surgery.

DRUG

Cisplatin

Patients in Group III will receive cisplatin, 30 mg/m2, administered intravenously weekly per for 6 weeks.

PROCEDURE

Incisional Tumor Biopsy

Incisional biopsy of the primary tumor site will be required to confirm p16/HPV status of the tumor

OTHER

Circulating tumor deoxyribonucleic acid (ctDNA) levels assessment

Assess ctDNA levels at baseline, 2 weeks, 4 weeks, 10 weeks, 24 weeks and 1 year after the surgery.

OTHER

MD Anderson Dysphagia Index

MDADI is a 20 item quality of life questionnaire specifically focusing on swallowing aspects. It was originally designed for head and neck cancer patients. The total score ranges from 20 to 100 with the higher score indicating higher level of function.

OTHER

University of Washington Quality of Life Questionnaire

University of Washington Questionnaire is a 15 item quality of life instrument specifically designed for head and neck cancer patients.

OTHER

Euro-QOL 5 dimension scale questionnaire

A generic quality of life and cost utility instrument widely used and validated for multiple disease settings, including head and neck cancer.

DIAGNOSTIC_TEST

Modified barium swallow (MBS) evaluation with aspiration-penetration scale

The videofluoroscopic modified barium swallow (MBS) study is the gold standard for for the evaluation of dysphagia, and specifically, airway protective mechanisms. The penetration/aspiration (PEN/ASP) scale is a routinely used eight-point scale designed to describe the depth of bolus penetration into the airway and the patient response to the penetration or aspiration.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Rutgers, The State University of New Jersey

  lead OTHER

Principal Investigators

• Matin Imanguli, MD, DDS · Rutgers Cancer Institute of New Jersey

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-07-19

Primary Completion

2025-05-08

Completion

2025-05-08

FDA Drug

Yes

Countries

• United States

Study Locations