Adjuvant Treatment Deintensification After Transoral Surgery for Human Papillomavirus-Positive Squamous Cell Carcinoma

NCT05119036 | Active Not Recruiting DMC FDA Device

• 1 other identifier: OTHN-CC-IUSCCC-0756
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 2

Brief Summary

Oropharyngeal squamous cell carcinoma (OPSCC), commonly known as throat cancer or tonsil cancer, has seen a dramatic rise in incidence over the last twenty years. There are two types of OPSCC: human papillomavirus-positive (HPV+) and human papillomavirus-negative (HPV-). People with OPSCC, regardless of their type, typically receive standard treatment with a combination of chemotherapy, radiation therapy, and surgery. Due to the intensity of standard treatment, survivors may experience unwanted long-term side effects. The goal of this research study is to see if intensifying (stopping or scaling back) treatment still provides the same, or perhaps even better, results when compared to standard treatment.

Conditions

Squamous Cell Carcinoma of the Oropharynx; HPV Positive Oropharyngeal Squamous Cell Carcinoma

Keywords

transoral surgery; HPV

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  Time from surgery to first disease recurrence or death from any cause

  Day 1 until death, assessed up to 2 years

Secondary Outcomes (6)

• Loco-regional control

  Day 1 - Day 365

• Overall survival

  Day 1 until death, assessed up to 2 years

• Distant metastasis rates

  Day 1 - Day 365

• Toxicity from radiation

  Day 1 - Day 180

• Swallowing-related Quality of Life

  at 3 months, 6 months, 1 year, and 2 year post-treatment

Study Arms (3)

Observation

NO INTERVENTION

If patients have negative margins and have all negative nodes or only a single positive node, patients will be placed in the observation arm and will not receive further adjuvant treatment, only postoperative follow-up visits and a surveillance visit 3 months after surgery with a CT or PET-CT.

Adjuvant Radiation 44 Gray

EXPERIMENTAL

If patients have 4 or fewer positive nodes and 2 mm or less of cancer spread extending outside the lymph nodes, patients will receive 44 gray fractions (the full dose of radiation divided into smaller doses) of adjuvant radiation.

Radiation: 44 doses of radiation

Adjuvant Radiation 54 Gray

EXPERIMENTAL

If patients have 4 or fewer positive nodes with greater than 2 mm of cancer spread extending outside the lymph nodes or 5 or more positive nodes with 2 mm or less of cancer spread extending outside the lymph nodes, patients will receive 54 gray fractions (the full dose of radiation divided into smaller doses) of adjuvant radiation.

Radiation: 54 doses of radiation

Interventions

44 doses of radiation RADIATION

Patients will receive 44 gray in 22 fractions to the operative bed, including the primary tumor site and dissected nodal basin. Patients will receive 40 gray in 22 fractions to undissected areas of the neck at low-risk for occult disease.

Adjuvant Radiation 44 Gray

54 doses of radiation RADIATION

Patients will receive 54 gray in 27 fractions to the operative bed, including the primary tumor site and dissected nodal basin. Patients will receive 50 gray in 27 fractions to undissected areas of the neck at low-risk for occult disease.

Adjuvant Radiation 54 Gray

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects ≥ 18 years old at the time of informed consent.
• Ability to provide written informed consent and HIPAA authorization.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (refer to Appendix).
• Primary tumor of the oropharynx (palatine tonsil, tongue base, soft palate, lateral or posterior walls of oropharynx).
• Histopathologically confirmed squamous cell carcinoma.
• HPV+ tumor, as determined by p16, in-situ hybridization, or real-time polymerase chain reaction.
• Note: If patients present who have unconfirmed p16/HPV positive disease but have clinical findings that indicate a high probability of HPV positive disease, these patients can be deemed eligible after testing is performed at post-surgery.
• Resectable and accessible tumor with high probability of achieving negative margins.
• Smokers and non-smokers included.
• Tumor stage (AJCC 8th edition): T1 or T2.
• Nodal stage (AJCC 8th edition): N0, N1 or N2.
• Mobile neck nodes on physical exam if N positive.
• Subjects with synchronous primaries included.
• Subjects with unknown primaries included if primary is definitively identified and resectable with negative margins or if the palatine and lingual tonsils are thoroughly resected and pathologically proven to be negative for a primary.

You may not qualify if:

• Serious medical condition preventing general anesthesia for surgery.
• Inability to complete full course of radiation treatment or attend follow-up visits.
• History of previous head and neck radiation or previous head and neck cancer within 3 years.
• Distant metastatic disease present.
• Prior invasive malignant disease within 3 years, with the exception of non-melanoma skin cancer and thyroid cancer, unless patient is deemed cured or disease free, in which case patient may be included in the study.
• Lactating or pregnant women. Women of childbearing potential must have a negative pregnancy test within 60 days of protocol registration. Women are considered to have childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) unless the patients meet one of the following criteria:
• Has undergone a hysterectomy or bilateral oophorectomy; or
• Has been naturally amenorrheic for at least 24 consecutive months.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (2)

IU Health Joe and Shelly Schwarz Cancer Center

Carmel, Indiana, 46032, United States

Location

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Radiation

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Michael Sim, MD

  Indiana University School of Medicine, Indiana University Simon Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Otolaryngology

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: November 12, 2021
• Study Start: May 12, 2022
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)