Ultrasound-enhanced Uptake of Chemotherapy in Patients With Inoperable Pancreatic Ductal Adenocarcinoma
PDAC
2 other identifiers
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2020
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2019
CompletedFirst Posted
Study publicly available on registry
October 31, 2019
CompletedStudy Start
First participant enrolled
February 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedJanuary 19, 2023
January 1, 2023
2.9 years
October 29, 2019
January 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
8 weeks
Secondary Outcomes (3)
Number of down-staged tumors from stage III to stage II
8 weeks
Number of down-staged tumors from stage III to stage II
1 year
Rate of reported toxicity
8 weeks
Study Arms (2)
SonoVue
EXPERIMENTALSonoVue + chemotherapy
control
ACTIVE COMPARATORchemotherapy
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. Olavs Hospitallead
- Norwegian University of Science and Technologycollaborator
Study Sites (1)
Department of Radiology, St Olavs Hospital
Trondheim, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eva Hofsli, md phd
St. Olavs Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2019
First Posted
October 31, 2019
Study Start
February 10, 2020
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
January 19, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- Time Frame
- Protocol can be shared beginning 3 months and ending 5 years following article publication.
- Access Criteria
- Researchers who provide a reasonable, sound proposals are encouraged to direct this to the first author at margrete.haram@stolav.no
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.