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Ultrasound-enhanced Uptake of Chemotherapy in Patients With Inoperable Pancreatic Ductal Adenocarcinoma (PDAC)

Primary Purpose

Carcinoma, Pancreatic Ductal

Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
SonoVue
Chemotherapy
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Pancreatic Ductal focused on measuring Contrast agent BR, SonoVue, Ultrasonic therapy, Microbubbles

Eligibility Criteria

19 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Radiologically verified stage III or IV PDAC or medically inoperable stage IIB T3 PDAC
  • eligible for 1st line treatment with FOLFIRINOX, Gemcitabine -nab Paclitaxel, or Gemcitabine monotherapy.
  • ECOG 0 - 1

Exclusion Criteria:

  • Known contraindications for SonoVue
  • Hematological bleeding status before experimental treatment:
  • Hb < 8g/dL, trc < 80 x10 superscr 9/l, APTT˃ 45s, INR ˃ 1,5
  • Pregnancy

Sites / Locations

  • Department of Radiology, St Olavs Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SonoVue

control

Arm Description

SonoVue + chemotherapy

chemotherapy

Outcomes

Primary Outcome Measures

Volume change of primary tumor
measured by segmented tumor volumes on Computed Tomography of primary PDAC tumor from before treatment (baseline) to after 1 cycle of treatment

Secondary Outcome Measures

Number of down-staged tumors from stage III to stage II
Number of down-staged tumors from stage III to stage II
Rate of reported toxicity
Toxicity reported by patients during structured interview after treatment. Type of side effects and severity according to Common Toxicity Criteria (CTC)

Full Information

First Posted
October 29, 2019
Last Updated
January 17, 2023
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT04146441
Brief Title
Ultrasound-enhanced Uptake of Chemotherapy in Patients With Inoperable Pancreatic Ductal Adenocarcinoma
Acronym
PDAC
Official Title
Ultrasound-enhanced Uptake of Chemotherapy in Patients With Inoperable Pancreatic Ductal Adenocarcinoma - A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients with inoperable pancreatic cancer have extremely poor prognosis with five year survival below 8% in Norway. Life-prolonging chemotherapy has very limited effect, but is the only therapeutic option for these patients. This tumor is characterized by poor uptake and chemoresistance. Toxic effects on healthy tissue restrict doses applied and maintenance of treatment intensity. This severely limits clinical outcome. Increasing the local uptake of chemotherapy has potential benefits for patients in connection to side effects, survival and possible cure. Treatment with Focused Ultrasound (FUS) combined with microbubbles (MBs) is proved promising to improve treatment response in animal and clinical trials. Ultrasound can induce biological effects deep inside the body without surgical intervention. This opens for local delivery of drugs at desired sites. FUS in combination with regular contrast MBs has been reported to influence the delivery of drugs to tumors. In this trial FUS and MB will be applied to locally advanced pancreatic cancers shortly after the administration of conventional chemotherapy. Primary aim of the trial is to investigate whether the effect of the cytostatic drug, measured in tumor volume, can be increased.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Pancreatic Ductal
Keywords
Contrast agent BR, SonoVue, Ultrasonic therapy, Microbubbles

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SonoVue
Arm Type
Experimental
Arm Description
SonoVue + chemotherapy
Arm Title
control
Arm Type
Active Comparator
Arm Description
chemotherapy
Intervention Type
Combination Product
Intervention Name(s)
SonoVue
Intervention Description
1,0 ml SonoVue 8ul/ml dispersion is given 9 times at 3,5 minute intervals 9 times, a total dosage of 9 ml. The experimental treatment lasts for 31,5 minutes every treatment day. Administered by authorized site personnel only
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
FOLFIRINOX Regime according to Norwegian national guidelines
Primary Outcome Measure Information:
Title
Volume change of primary tumor
Description
measured by segmented tumor volumes on Computed Tomography of primary PDAC tumor from before treatment (baseline) to after 1 cycle of treatment
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Number of down-staged tumors from stage III to stage II
Time Frame
8 weeks
Title
Number of down-staged tumors from stage III to stage II
Time Frame
1 year
Title
Rate of reported toxicity
Description
Toxicity reported by patients during structured interview after treatment. Type of side effects and severity according to Common Toxicity Criteria (CTC)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Radiologically verified stage III or IV PDAC or medically inoperable stage IIB T3 PDAC eligible for 1st line treatment with FOLFIRINOX, Gemcitabine -nab Paclitaxel, or Gemcitabine monotherapy. ECOG 0 - 1 Exclusion Criteria: Known contraindications for SonoVue Hematological bleeding status before experimental treatment: Hb < 8g/dL, trc < 80 x10 superscr 9/l, APTT˃ 45s, INR ˃ 1,5 Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Hofsli, md phd
Organizational Affiliation
St. Olavs Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Radiology, St Olavs Hospital
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification(text, tables, figures, and appendices). Interested researchers who provide a reasonable, sound proposal are encouraged to direct this to the first author.
IPD Sharing Time Frame
Protocol can be shared beginning 3 months and ending 5 years following article publication.
IPD Sharing Access Criteria
Researchers who provide a reasonable, sound proposals are encouraged to direct this to the first author at margrete.haram@stolav.no

Learn more about this trial

Ultrasound-enhanced Uptake of Chemotherapy in Patients With Inoperable Pancreatic Ductal Adenocarcinoma

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