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

NCT ID: NCT04146441

Last Updated: 2023-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-10
• Study Completion Date: 2022-12-31

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.

Conditions

Carcinoma, Pancreatic Ductal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SonoVue

SonoVue + chemotherapy

Group Type: EXPERIMENTAL

SonoVue

Intervention Type: COMBINATION_PRODUCT

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

Chemotherapy

Intervention Type: DRUG

FOLFIRINOX Regime according to Norwegian national guidelines

control

chemotherapy

Group Type: ACTIVE_COMPARATOR

Chemotherapy

Intervention Type: DRUG

FOLFIRINOX Regime according to Norwegian national guidelines

Interventions

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

Intervention Type: COMBINATION_PRODUCT

Chemotherapy

FOLFIRINOX Regime according to Norwegian national guidelines

Intervention Type: DRUG

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwegian University of Science and Technology

OTHER

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eva Hofsli, md phd

Role: STUDY_DIRECTOR

St. Olavs Hospital

Locations

Department of Radiology, St Olavs Hospital

Trondheim, , Norway

Countries

Norway

Other Identifiers

2019-001736-57

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

040376MH

Identifier Type: -

Identifier Source: org_study_id