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2020-02-10
2022-12-31
2022-12-31
20
NCT04146441
St. Olavs Hospital
St. Olavs Hospital
INTERVENTIONAL
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-10-29 | N/A | 2023-01-17 |
2019-10-29 | N/A | 2023-01-19 |
2019-10-31 | N/A | 2023-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: SonoVue SonoVue + chemotherapy | COMBINATION_PRODUCT: SonoVue
DRUG: Chemotherapy
|
| ACTIVE_COMPARATOR: control chemotherapy | DRUG: Chemotherapy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 | Toxicity reported by patients during structured interview after treatment. Type of side effects and severity according to Common Toxicity Criteria (CTC) | 8 weeks |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
19 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
