Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HPV Positive Oropharyngeal Squamous Cell Carcinoma | Human Papillomavirus-Related Oropharyngeal Squamous Cell Carcinoma | ALIAS | 0.90 |
| Squamous Cell Carcinoma of the Oropharynx | Oropharyngeal Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 44 doses of radiation | Radiation | — | UNRESOLVED |
| 54 doses of radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Observation
- description
- 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.
- type
- EXPERIMENTAL
- label
- Adjuvant Radiation 44 Gray
- description
- 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.
- interventionNames
- Radiation: 44 doses of radiation
- type
- EXPERIMENTAL
- label
- Adjuvant Radiation 54 Gray
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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: 1. Has undergone a hysterectomy or bilateral oophorectomy; or 2. Has been naturally amenorrheic for at least 24 consecutive months.
References
Publications (0)
Data not yet available