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Head and Neck CancerEarly Phase 1NCT02794675

Intraoperative Placement of Cesium-131 Permanent Interstitial Brachytherapy in Head and Neck Cancer

A Early Phase 1 study testing Cesium 131 in people with Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, run by Case Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to explore the use of a treatment called interstitial brachytherapy for patients who have a high risk resectable (able to be treated with surgery) recurrent head and neck cancer. Read more about this study

Who is it for?
Ages 19 to 90 years
What is being tested?
Cesium 131
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
21 Dec 2016to 24 Jul 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 19 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must have histologically or cytologically confirmed recurrent head and neck cancer.
  • Based on clinical and radiographic evidence the tumor needs to be deemed resectable preoperatively by the surgeon and when necessary (determined by the surgeon) tumor board review.
  • Patients must have potentially curable disease
  • Karnofsky Performance status ≥ 60% (ECOG/Zubrod 0,1,or 2)
  • Subjects must have normal organ and marrow function as defined below:
  • Hemoglobin ≥ 7.0 g/dl
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  • Absolute neutrophil count (ANC) > 500/mcL
  • Platelet count ≥ 75,000/mcL
  • Patients with recurrent/previous treated head and neck squamous cell carcinoma that is deemed surgically resectable by the treating physician but at high risk for recurrence due to concerns regarding close and/or margins due to locations on or near critical structures such as internal or common carotid, skull base, deep cervical musculature, and other areas that may limit the possibility of an enbloc resection. This group otherwise would be considered for retreatment with radiation and/or chemoradiation.
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Patients deemed to have un-resectable disease by the treating surgeon or upon tumor board review.
  • Patients with exposed carotid artery preoperatively requiring sacrifice or bypass intra-operatively
  • Patients with active pharyngocutaneous fistula
  • Patients may have had a recent previous hospital admission (within 30 days) or be admitted preoperatively but not for the following conditions
  • Unstable angina
  • Congestive heart failure
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  • Severe hypothyroidism TSH >10
  • ---- Endocrine consult and intervention may allow participation at the discretion of the principal investigator for a thyroid-stimulating hormone (TSH) > 10.
  • Patients deemed to be "High Risk" by pre admission testing (CPM) or by a preoperative risk assessment by the hospitalist for perioperative complications
  • Subjects with more than one site of distant metastatic disease (beyond the head and neck) as evidenced by computerized tomography (CT) scan or positron emission tomography/CT (PET/CT) or biopsy ---- A subject with a single lung nodule (deemed cancerous by PET/CT or Biopsy) will not be excluded.
  • Subjects receiving any other investigational agents.
  • Subjects with untreated brain metastases/central nervous system disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to Cesium 131 or other agents used in this study.
  • Pregnant or breastfeeding women are excluded from this study because Cesium 131 has the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with Cesium 131, breastfeeding should be discontinued if the mother is treated with Cesium 131. These potential risks may also apply to other agents used in this study.
  • Subjects who are HIV-positive will be excluded from the study. HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with Cesium 131. In addition, these subjects are at increased risk of lethal infections when treated with marrow suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: A Pilot Study Using Intraoperative Placement of Cesium-131 Permanent Interstitial Brachytherapy in Resectable High Risk Recurrent Head and Neck Cancer

The purpose of this study is to explore the use of a treatment called interstitial brachytherapy for patients who have a high risk resectable (able to be treated with surgery) recurrent head and neck cancer.

Brachytherapy is a form of radiation therapy that uses radioactive seeds and implants them into a specific place on your body. This study is using Cesium-131 permanent interstitial brachytherapy.

Cesium-131 is FDA approve for brachytherapy use, however, there are currently no research studies to show how effective it is for head and neck cancer. The goal of this study is determine the effect that the placement of Cesium-131 brachytherapy seeds has on overall survival as well as to assess possible side effects.

Read the detailed description

Primary Objective:

To assess the effect of Cesium 131 brachytherapy in subjects with resectable recurrent cancer of the head and neck by evaluating disease free survival (DFS) and comparing to a previous cohort. Potential effects on locoregional control rate and overall survival will be explored.

Secondary Objective:

To assess toxicity associated with cesium 131 brachytherapy treatment.

Study Design Patients with a head and neck recurrent cancer who are planned to undergo definitive tumor resection surgery that meet our inclusion and exclusion criteria will be offered participation in this clinical trial.

Participant's Follow-up. The participant's medical records will be reviewed every 3 months for 24 months to assess: loco-regional control, distant metastasis free survival, disease free survival, and overall survival. This will allow us to assess the potential treatment effect of cesium 131.

Being tested
Cesium 131
Keywords
resectable, Cesium 131, brachytherapy
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cesium 131Drug

    Also called Cs-131, Cesium

    The number sources and activity will be based on the target volume to deliver total radiation dose, this will vary per patient.

Study groups in NCT02794675
Study groupRoleWhat they receive
Cesium 131 brachytherapyExperimentalCesium 131 is the radioactive isotope in the protocol. The prescribed dose will range from 50-80 Gy at maximal delivery. It comes in 0.5 cm seeds that will be placed in the tumor resection bed at 1cm intervals. They are implantable seeds that do not require removal.
Receives: Drug: Cesium 131

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median disease free survival (DFS)

    DFS defined as the time of diagnosis with no evidence of disease through death by any cause or relapse of disease.

    Measured: Up to two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2016 (estimated)
  2. Study start21 Dec 2016
  3. Primary completion24 Jul 2020
  4. Study completion24 Jul 2020

Resources

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
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02794675
Sponsor's protocol ID
CASE5315
Other IDs
NCI-2017-00023
Status last verified
Dec 2020
First submitted
6 Jun 2016
Last updated
23 Dec 2020
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

  • Kharouta M, Zender C, Podder T, Rezaee R, Lavertu P, Fowler N, Thuener J, Li S, Clancy K, Xu Z, Yao M. Permanent Interstitial Cesium-131 Brachytherapy in Treating High-Risk Recurrent Head and Neck Cancer: A Prospective Pilot Study. Front Oncol. 2021 Mar 18;11:639480. doi: 10.3389/fonc.2021.639480. eCollection 2021.

    PubMed 33816283

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Cesium 131 in people with Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, run by Case Comprehensive Cancer Center 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 10 inclusion and 15 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 23 Dec 2020. 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?

Median disease free survival (DFS) (time frame: Up to two years). 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 NCT02794675, which also lists 2 linked publications.

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 23 Dec 2020.

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