NCT05119036Completed
Adjuvant Treatment Deintensification After Transoral Surgery for Human Papillomavirus-Positive Squamous Cell Carcinoma
Adjuvant Treatment Deintensification After Transoral Surgery for Human Papillomavirus-Positive Squamous Cell Carcinoma of the Oropharynx
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 82 (actual)
- First submitted
- 22 Sept 2021
- Start date
- 12 May 2022
- Primary completion date
- 13 Jul 2026
- Lead sponsor
- Indiana University
- Diseases
- Head and neck cancer, Childhood cancers
- NCT number
- NCT05119036
What you commit to
- Study type: Interventional
- Participants enrolled: 82
- From 12 May 2022 to the primary completion date, 13 Jul 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Serious medical condition preventing general anesthesia for surgery.
- 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.
Other
- 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.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IU Health Joe and Shelly Schwarz Cancer Center Coordinator of this site? Confirm its status | Carmel | United States | Unknown status |
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.