Clinical trial NCT02467738: Surgical Resection and Intraoperative Cesium-131 Brachytherapy for Head and Neck Cancer
Official title: A Pilot Study Using Surgical Resection and Intraoperative Cesium-131 Permanent Interstitial Brachytherapy Implant in Resectable Recurrent Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Recurrent Head and Neck Carcinoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2015-06-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: PRIMARY OBJECTIVES:

I. Assess the impact of cesium 131 (cesium Cs 131) on recurrence rate, disease free survival and over all survival.

SECONDARY OBJECTIVES:

I. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Disease free survival (DFS)
timeFrame: Up to 24 months
measure: Incidence of toxicity
timeFrame: Up to 90 days
Secondary outcomes:
measure: Recurrence rate
timeFrame: Up to 24 months
measure: Overall survival
timeFrame: Up to 24 months
measure: Complication rate
timeFrame: Up to 24 months
measure: Adverse event rate
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Adam Luginbuhl, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.