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Completed

NCT Number: NCT04146441

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SonoVue

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

Drug

FOLFIRINOX Regime according to Norwegian national guidelines

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian University of Science and Technology

Registry information

Official study title

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

Acronym: PDAC

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 31, 2019
Registry last updated
Jan 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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