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

Sponsor

St. Olavs Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04146441

Collaborator

Norwegian University of Science and Technology (Other)

Enrollment

Location

Arms

42.7

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Feb 10, 2020

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

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

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

Primary Outcome Measures

Volume change of primary tumor [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

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]
Toxicity reported by patients during structured interview after treatment. Type of side effects and severity according to Common Toxicity Criteria (CTC)

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 89 Years

Sexes Eligible for Study:

All

Accepts 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.
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