Clinical trial NCT03998566: Radiopaque Hydrogel Spacer in Patients Undergoing Radiotherapy for Pancreatic Cancer
Official title: Early Feasibility Study For Evaluation Of The TraceIT® Tissue Spacer For Creating Space Between The Duodenum And Pancreas In Patients With Localized Pancreatic Cancer Undergoing Radiation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Keywords: Radiotherapy
Radiation
SBRT
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2019-06-26
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An early feasibility study to evaluate feasibility, radiotherapy benefits and safety when using TraceIT tissue spacer to create space between pancreas and duodenum in patients with localized Pancreatic Cancer.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old
2. Biopsy-confirmed localized pancreatic cancer in the head or neck of the pancreas as defined by the NCCN guidelines
3. Tumor is clearly delineable from duodenum and no clear evidence of invasion of the duodenum is seen at time of EUS performed for either diagnosis or fiducial placement.
4. Subject is able to comply with motion management guidelines.
5. Radiotherapy or chemoradiotherapy for treatment of the disease is indicated.
6. In Investigator's opinion, medically fit to undergo endoscopy for fiducial marker implantation and TraceIT administration.
7. Subjects Screening/Baseline laboratory testing must meet the following laboratory value criteria:

   1. White blood cell count: ≥ 3.0 x 109/L
   2. Absolute neutrophil count (ANC): ≥ 1.5 x 109/L
   3. Platelets: ≥ 100 x 109/L
   4. Total bilirubin: ≤ 2.0 times upper limit of normal (ULN)
   5. AST and ALT: ≤ 3.0 times institutional upper normal limit
   6. Serum creatinine: \< 1.5 times ULN e
   7. INR: \< 1.5
   8. Serum pregnancy: Negative
   9. Hemoglobin: ≥ 8.0 g/dl
8. Zubrod Performance Status 0-2
9. Subject or authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) of the respective clinical site.
10. Life expectancy of at least 9 months

Exclusion Criteria:

1. Patients for whom radiotherapy is contraindicated
2. Previous thoracic or abdominal radiotherapy
3. Any GI abnormality that would interfere with the ability to access the injection site
4. Presence of tumor invasion of the duodenum detected on EUS at time of biopsy
5. Previous Whipple procedure or other resection of pancreatic tumor prior to screening
6. Active gastroduodenal ulcer or uncontrolled watery diarrhea
7. History of Chronic Renal Failure.
8. Documented history of uncontrolled diabetes (i.e., symptomatic hyperglycemia that cannot be medically managed, fasting blood glucose level above 300 mg/dL, and/or frequent swings between hyperglycemia and hypoglycemia)
9. Currently enrolled in another investigational drug or device trial that clinically interferes with this study.
10. Unable to comply with the study requirements or follow-up schedule.
11. Any condition or comorbidity that the Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the subject.
12. Women who are pregnant or breast-feeding; women of child-bearing age must use contraceptives.

Primary outcomes:
measure: Safety Endpoint
timeFrame: 2-6 week assessment post-procedure
Secondary outcomes:
measure: Radio-Therapy Benefits of TraceIT
timeFrame: 2-6 week assessment
measure: Feasibility of TraceIT
timeFrame: 2-6 week assessment post-procedure
measure: TraceIT Persistence (at 6-months Post-treatment)
timeFrame: 2-6 weeks and 6 month post procedure
measure: Theoretical Dose Escalation From Post-TraceIT Treatment Plan
timeFrame: 2-6 week assessment Post-procedure
measure: Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing
timeFrame: 18 months post procedure
measure: Incidence of Resection Following the Completion of Radiation Therapy (RT)
timeFrame: 2-6 weeks post procedure
measure: Progression Free and Overall Survival
timeFrame: 18 months post procedure
measure: Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30)
timeFrame: Changes in baseline at the Final RT appointment, 3 month, 6 month, 12 month and 18 month
Other outcomes:
measure: Comparability of Visualization of the Fiducial Marker and TraceIT Hydrogel
timeFrame: 2-5 weeks assessment post procedure
measure: TraceIT Stability and Space Measurements
timeFrame: Pre-TraceIT and Post-TraceIT procedure, up to 2-6 weeks follow-up post radiation therapy
measure: Changes From Baseline Final RT Appointment, 3 Months, 6 Months, 12 Months, and 18 Months in QLQ-PAN26
timeFrame: Changes from baseline final RT appointment, 3 months, 6 months, 12 months, and 18 months in QLQ-PAN26
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medicine
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
References: