Recurrent Head and Neck CarcinomaEarly Phase 1NCT02467738
Surgical Resection and Intraoperative Cesium-131 Brachytherapy for Head and Neck Cancer
A Early Phase 1 study testing Brachytherapy, Cesium-131 and Conventional surgery in people with Recurrent Head and Neck Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Recurrent Head and Neck Carcinoma
- What is being tested?
- Brachytherapy, Cesium-131 and Conventional surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2015to 28 May 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Pilot Study Using Surgical Resection and Intraoperative Cesium-131 Permanent Interstitial Brachytherapy Implant in Resectable Recurrent Head and Neck Cancer
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Assess the impact of cesium 131 (cesium Cs 131) on recurrence rate, disease free survival and over all survival.
SECONDARY OBJECTIVES:
- Assess complications associated with cesium 131 treatment in subjects with head and neck cancer.
OUTLINE:
Patients undergo brachytherapy using cesium Cs 131 during surgical resection.
After completion of study treatment, patients are followed up at 30 days and then every 3 months for 24 months.
- Conditions
- Recurrent Head and Neck Carcinoma
- Being tested
- Brachytherapy, Cesium-131, Conventional surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrachytherapyRadiation
Undergo brachytherapy with Cesium-131
Cesium-131Drug
Undergo brachytherapy with Cesium-131
Conventional surgeryProcedure or surgery
Undergo surgical resection
| Study group | Role | What they receive |
|---|---|---|
| Cesium-131 Brachytherapy | Experimental | Patients undergo brachytherapy using Cesium-131 during surgical resection Receives: Radiation: Brachytherapy; Drug: Cesium-131; Procedure: Conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Up to 90 days
Secondary outcomes (4)
Recurrence rate
Comparisons of 6-month and one-year recurrence rates will be performed using logistic regression
Measured: Up to 24 months
Overall survival
The distribution of overall survival 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.
Measured: Up to 24 months
Complication rate
Estimated by cohort along with exact 95% confidence intervals
Measured: Up to 24 months
Adverse event rate
Evaluated using the National Cancer Institute, Common Terminology Criteria for Adverse Events version 4.0
Estimated by cohort along with exact 95% confidence intervals
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study start17 Mar 2015
- Primary completion28 May 2020
- Study completion28 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Head and Neck CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam Luginbuhl, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467738
- Sponsor's protocol ID
- 15D.067
- Other IDs
- 2014-112, JT 7243
- Status last verified
- Sep 2025
- First submitted
- 5 Jun 2015
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 34900741
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Using Surgical Resection and Intraoperative Cesium-131 Permanent Interstitial Brachytherapy Implant in Resectable Recurrent Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT02467738
- Acronym / sponsor ID
- 15D.067
- Conditions
- Recurrent Head and Neck Carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 17 Mar 2015 (actual)
- Primary completion
- 28 May 2020 (actual)
- Study completion
- 28 May 2020 (actual)
- First posted
- 10 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- Assess the impact of cesium 131 (cesium Cs 131) on recurrence rate, disease free survival and over all survival.
SECONDARY OBJECTIVES:
- Assess complications associated with cesium 131 treatment in subjects with head and neck cancer.
OUTLINE:
Patients undergo brachytherapy using cesium Cs 131 during surgical resection.
After completion of study treatment, patients are followed up at 30 days and then every 3 months for 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cesium-131 Brachytherapy | Experimental | Radiation: Brachytherapy, Drug: Cesium-131, Procedure: Conventional surgeryPatients undergo brachytherapy using Cesium-131 during surgical resection |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrachytherapyUndergo brachytherapy with Cesium-131 | Radiation | Cesium-131 Brachytherapy |
| Cesium-131Undergo brachytherapy with Cesium-131 | Drug | Cesium-131 Brachytherapy |
| Conventional surgeryUndergo surgical resection | Procedure or surgery | Cesium-131 Brachytherapy |
Primary outcome
Disease free survival (DFS)
Time frame: Up to 24 months
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
Incidence of toxicity
Time frame: Up to 90 days
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.
4 secondary outcomes
Recurrence rate
Time frame: Up to 24 months
Overall survival
Time frame: Up to 24 months
Complication rate
Time frame: Up to 24 months
Adverse event rate
Time frame: Up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Derived from this study: PubMed 34900741Luginbuhl 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.
- Jefferson University HospitalsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Luginbuhl, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Brachytherapy, Cesium-131 and Conventional surgery in people with Recurrent Head and Neck Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (DFS) (time frame: Up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02467738, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.