Radiopaque Hydrogel Spacer in Patients Undergoing Radiotherapy for Pancreatic Cancer

Not Applicable

Completed

• Conditions: Pancreatic Cancer
• Interventions: Device: TraceIT Tissue Spacer implantation

• Registration Number: NCT03998566
• Lead Sponsor: Boston Scientific Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-24
• Study First Submitted: 2019-06-13
• Study First Submitted QC: 2019-06-24
• Study First Posted: 2019-06-26
• Primary Completion: 2021-05-01
• Study Completion: 2021-05-01
• Results First Submitted: 2022-04-18
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-22
• Last Update Submitted: 2023-02-22
• Results First Posted: 2023-02-27
• Last Update Posted: 2023-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TraceIT Tissue Spacer	TraceIT Tissue Spacer implantation	-

Primary Outcome Measures

Name	Time	Method
Safety Endpoint	2-6 week assessment post-procedure	Number of subjects with TraceIT procedure-related event which resulted in a delay in initiation for RT (radio-therapy).

Secondary Outcome Measures

Name	Time	Method
Progression Free and Overall Survival	18 months post procedure	Progression-free survival is the interval between the start of induction chemotherapy (prior to Radiation Therapy) to the earliest treatment failure onset date, or death, in months. Overall survival is the interval between the start of induction chemotherapy (prior to radiation therapy) to death in month.
Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30)	Changes in baseline at the Final RT appointment, 3 month, 6 month, 12 month and 18 month	The EORTC QOL QLQ-C30 is a questionnaire used to assess patient-reported symptoms and outcomes during cancer treatment. The survey contains 28 questions scored on a 4-point Likert scale (1 = 'Not at all' to 4 'Very much') and 2 questions on a 7-point numerical scale (1 = 'Very poor' to 7 = 'Excellent').Questions are grouped into 15 categories containing 1 to 5 different questions per category. All scores were transformed to a 0-100 scale following instructions in the scoring manual. Raw scores calculated as the average of component items are then standardized using linear transformation to a score ranging from 0-100. Higher score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems.
Radio-Therapy Benefits of TraceIT	2-6 week assessment	Number of subjects who were able to maintain safe duodenal dose constraints. RT benefits were assessed via comparison of pre- and post-TraceIT administration RT plans with consideration of the following: ability to maintain safe duodenal dose constraints, percent/volume of gross tumor volume/planning target volume (GTV/PTV) receiving prescription dose and overall duodenal dose/dose distribution.
Feasibility of TraceIT	2-6 week assessment post-procedure	Number of subjects who achieved Technical Success (the ability to place TraceIT and create space between the duodenum and head of pancreas (HOP).
TraceIT Persistence (at 6-months Post-treatment)	2-6 weeks and 6 month post procedure	Characteristics of TraceIT persistence and migration were measured at 2 to 6 weeks and 6 months following injection. Persistence was measured at the 2 to 6 week and 6 month follow-ups by assessing whether a cohesive mass of water density fluid was present in the periduodenal space following the last radio therapy appointment. Migration of the TraceIT post Radiation was measured by CT scan taken at 2-6 weeks follow-up.
Theoretical Dose Escalation From Post-TraceIT Treatment Plan	2-6 week assessment Post-procedure	Maximum dose to the GTV while maintaining duodenal dose constraints
Incidence of Resection Following the Completion of Radiation Therapy (RT)	2-6 weeks post procedure	Number of subjects with resection following the completion of radiation therapy (RT). Within 2-6 weeks after completion of therapy, subjects were restaged to determine whether they may progress for surgery (resection).
Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing	18 months post procedure	Number of subject with Duodenal AE summarized by CTCAE grade and timing

Trial Locations

Locations (3)

Johns Hopkins Medicine; 🇺🇸 Baltimore, Maryland, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States