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

Carcinoma, Pancreatic Ductal Clinical Trial

— PDAC  

Official title:

Ultrasound-enhanced Uptake of Chemotherapy in Patients With Inoperable Pancreatic Ductal Adenocarcinoma - A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04146441
• Other study ID #: 040376MH
• Secondary ID: 2019-001736-57
• Status: Completed
• Phase: Phase 2
• Start date: February 10, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Pancreatic Ductal

Intervention

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

Locations

Country	Name	City	State
Norway	Department of Radiology, St Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of down-staged tumors from stage III to stage II		8 weeks
Secondary	Number of down-staged tumors from stage III to stage II		1 year
Secondary	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)	8 weeks