N/A
Completed N=6
Radiopaque Hydrogel Spacer in Patients Undergoing Radiotherapy for Pancreatic Cancer
Source: ClinicalTrials.gov NCT03998566 ↗Enrolled (actual)
6
Serious AEs
100.0%
Results posted
Feb 2023
Primary outcomePrimary: Safety Endpoint — 6; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Endpoint |
6; 0 | — |
| SECONDARY Radio-Therapy Benefits of TraceIT |
6; 0 | — |
| SECONDARY Feasibility of TraceIT |
6; 0 | — |
| SECONDARY TraceIT Persistence (at 6-months Post-treatment) |
0; 2; 3; 0; 3; 2 | — |
| SECONDARY Theoretical Dose Escalation From Post-TraceIT Treatment Plan |
12.7 | — |
| SECONDARY Incidence of Acute (Within 3 Months) and Late (>3 Months) Duodenal Toxicity Summarized by CTCAE Grade and Timing |
6; 6; 4; 4; 3; 3 | — |
| SECONDARY Incidence of Resection Following the Completion of Radiation Therapy (RT) |
3; 3 | — |
| SECONDARY Progression Free and Overall Survival |
17.6; 20.0 | — |
| SECONDARY Changes From Baseline at the Final RT Appointment, 3 Month, 6 Month, 12 Month and 18 Month in EORTC QoL (QLQ-C30) |
-6.7; -11.1; 3.3; -29.2; 0; 1.3 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥18 years old
- Biopsy-confirmed localized pancreatic cancer in the head or neck of the pancreas as defined by the NCCN guidelines
- 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.
- Subject is able to comply with motion management guidelines.
- Radiotherapy or chemoradiotherapy for treatment of the disease is indicated.
- In Investigator's opinion, medically fit to undergo endoscopy for fiducial marker implantation and TraceIT administration.
- Subjects Screening/Baseline laboratory testing must meet the following laboratory value criteria:
- White blood cell count: ≥ 3.0 x 109/L
- Absolute neutrophil count (ANC): ≥ 1.5 x 109/L
- Platelets: ≥ 100 x 109/L
- Total bilirubin: ≤ 2.0 times upper limit of normal (ULN)
- AST and ALT: ≤ 3.0 times institutional upper normal limit
- Serum creatinine: < 1.5 times ULN e
- INR: < 1.5
- Serum pregnancy: Negative
- Hemoglobin: ≥ 8.0 g/dl
- Zubrod Performance Status 0-2
- 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.
- Life expectancy of at least 9 months
Exclusion Criteria
- Patients for whom radiotherapy is contraindicated
- Previous thoracic or abdominal radiotherapy
- Any GI abnormality that would interfere with the ability to access the injection site
- Presence of tumor invasion of the duodenum detected on EUS at time of biopsy
- Previous Whipple procedure or other resection of pancreatic tumor prior to screening
- Active gastroduodenal ulcer or uncontrolled watery diarrhea
- History of Chronic Renal Failure.
- 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)
- Currently enrolled in another investigational drug or device trial that clinically interferes with this study.
- Unable to comply with the study requirements or follow-up schedule.
- 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.
- Women who are pregnant or breast-feeding; women of child-bearing age must use contraceptives.
Data sourced from ClinicalTrials.gov (NCT03998566). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.