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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04146441
Recruitment Status : Recruiting
First Posted : October 31, 2019
Last Update Posted : January 3, 2022
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Carcinoma, Pancreatic Ductal Combination Product: SonoVue Drug: Chemotherapy Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultrasound-enhanced Uptake of Chemotherapy in Patients With Inoperable Pancreatic Ductal Adenocarcinoma - A Randomized Controlled Trial
Actual Study Start Date : February 10, 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SonoVue
SonoVue + chemotherapy
 Combination Product: SonoVue
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

Drug: Chemotherapy
FOLFIRINOX Regime according to Norwegian national guidelines
Active Comparator: control
chemotherapy
 Drug: Chemotherapy
FOLFIRINOX Regime according to Norwegian national guidelines


Outcome Measures
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Primary Outcome Measures :
  1. Volume change of primary tumor [ Time Frame: 8 weeks ]
    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 :
  1. Number of down-staged tumors from stage III to stage II [ Time Frame: 8 weeks ]
  2. Number of down-staged tumors from stage III to stage II [ Time Frame: 1 year ]
  3. Rate of reported toxicity [ Time Frame: 8 weeks ]
    Toxicity reported by patients during structured interview after treatment. Type of side effects and severity according to Common Toxicity Criteria (CTC)


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04146441


Contacts
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Contact: Margrete Haram, md 0047 72825677 margrete.haram@stolav.no

Locations
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Norway
Department of Radiology, St Olavs Hospital Recruiting
Trondheim, Norway
Contact: Margrete Haram, md       margrete.haram@stolav.no   
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Investigators
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Study Director: Eva Hofsli, md phd St. Olavs Hospital
More Information
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Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT04146441    
Other Study ID Numbers: 040376MH
2019-001736-57 ( EudraCT Number )
First Posted: October 31, 2019    Key Record Dates
Last Update Posted: January 3, 2022
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Olavs Hospital:
Contrast agent BR
SonoVue
Ultrasonic therapy
Microbubbles
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma, Pancreatic Ductal
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Ductal
Neoplasms, Ductal, Lobular, and Medullary
 Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases