Clinical trial · Interventional
Surgical Resection and Intraoperative Cesium-131 Brachytherapy for Head and Neck Cancer
A Pilot Study Using Surgical Resection and Intraoperative Cesium-131 Permanent Interstitial Brachytherapy Implant in Resectable Recurrent Head and Neck Cancer
- 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)
This pilot clinical trial studies cesium Cs 131 brachytherapy in treating patients with head and neck cancer that has come back (recurrent) and can be removed by surgery. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Radioactive drugs, such as cesium Cs 131, may carry radiation directly to tumor cells and not harm normal cells. Permanently implanting cesium Cs 131 into the wound bed after surgery may help treat microscopic cancer cells that may be in the tissue after surgical removal of the tumor.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Head and Neck Carcinoma | Head and Neck Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brachytherapy | Radiation | — | UNRESOLVED |
| Cesium-131 | Drug | — | UNRESOLVED |
| Conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cesium-131 Brachytherapy
- description
- Patients undergo brachytherapy using Cesium-131 during surgical resection
- interventionNames
- Radiation: Brachytherapy
- Drug: Cesium-131
- Procedure: Conventional surgery
Primary outcomes (2)
- measure
- Disease free survival (DFS)
- timeFrame
- Up to 24 months
- description
- Will assess the impact of cesium Cs 131 on DFS by comparing the cohort to a matched historical control cohort. The distribution of DFS will be estimated using the Kaplan-Meier and a stratified log rank test will be used to test for differences between cohorts. Adjustment for other potential confounders will be performed using stratified Cox proportional hazards regression
- measure
- Incidence of toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosis: Subjects with a diagnosis of recurrent head and neck cancer 2. Based on clinical and radiographic evidence the tumor needs to be deemed resectable preoperatively 3. Age: Subjects must be ≥ 18 years of age and ≤ 90 years old 4. Informed Consent: All subjects must be able to comprehend and sign a written informed consent document Exclusion Criteria: 1. Subjects who are pregnant or may become pregnant 2. Unresectable tumor 3. Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation, and in the judgment of the investigator would make the subject inappropriate for entry into this study
References
Publications (1)
- DERIVEDLuginbuhl A, Calder A, Kutler D, Zender C, Wise-Draper T, Patel J, Cheng M, Karivedu V, Zhan T, Parashar B, Gulati S, Yao M, Lavertu P, Takiar V, Tang A, Johnson J, Keane W, Curry J, Cognetti D, Bar-Ad V. Multi-Institutional Study Validates Safety of Intraoperative Cesium-131 Brachytherapy for Treatment of Recurrent Head and Neck Cancer. Front Oncol. 2021 Nov 26;11:786216. doi: 10.3389/fonc.2021.786216. eCollection 2021. PMID 34900741