Surgical Resection and Intraoperative Cesium-131 Brachytherapy for Head and Neck Cancer

NCT02467738 | Completed Early Phase 1 DMC FDA Drug

• 3 other identifiers: 15D.0672014-112JT 7243
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Recurrent Head and Neck Carcinoma

Outcome Measures

Primary Outcomes (2)

• Disease free survival (DFS)

  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

  Up to 24 months

• Incidence of toxicity

  Evaluated using the Radiation Therapy Oncology Group Common Toxicity Criteria Categories of risk include infection, wound breakdown, inability to heal, fistula formation, bleeding and need for further surgery.

  Up to 90 days

Secondary Outcomes (4)

• Recurrence rate

  Up to 24 months

• Overall survival

  Up to 24 months

• Complication rate

  Up to 24 months

• Adverse event rate

  Up to 30 days

Study Arms (1)

Cesium-131 Brachytherapy

EXPERIMENTAL

Patients undergo brachytherapy using Cesium-131 during surgical resection

Radiation: Brachytherapy; Drug: Cesium-131; Procedure: Conventional surgery

Interventions

Brachytherapy RADIATION

Undergo brachytherapy with Cesium-131

Cesium-131 Brachytherapy

Cesium-131 DRUG

Undergo brachytherapy with Cesium-131

Cesium-131 Brachytherapy

Conventional surgery PROCEDURE

Undergo surgical resection

Cesium-131 Brachytherapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis: Subjects with a diagnosis of recurrent head and neck cancer
• Based on clinical and radiographic evidence the tumor needs to be deemed resectable preoperatively
• Age: Subjects must be ≥ 18 years of age and ≤ 90 years old
• Informed Consent: All subjects must be able to comprehend and sign a written informed consent document

You may not qualify if:

• Subjects who are pregnant or may become pregnant
• Unresectable tumor
• 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

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• Luginbuhl 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 DERIVED

Related Links

• Jefferson University Hospitals

MeSH Terms

Interventions

Brachytherapy; Cesium-131

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Adam Luginbuhl, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2015
• First Posted: June 10, 2015
• Study Start: March 17, 2015
• Primary Completion: May 28, 2020
• Study Completion: May 28, 2020
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

US (1)