Chemotherapy Followed by Irreversible Electroporation in Patients With Unresectable Locally Advanced Pancreatic Cancer (CHEMOFIRE-2)
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|ClinicalTrials.gov Identifier: NCT04093141|
Recruitment Status : Recruiting
First Posted : September 17, 2019
Last Update Posted : October 28, 2019
This study is a single-arm clinical trial of irreversible electroporation (IRE) for the treatment of unresectable locally advanced pancreatic cancer (LAPC).
The aim of the study is to evaluate the efficacy of IRE in this patient group. A statistical analysis of patient survival will be performed, comparing study participants to historical data from the Danish national database of pancreatic cancer patients.
|Condition or disease||Intervention/treatment||Phase|
|Unresectable Pancreatic Cancer||Procedure: IRE||Not Applicable|
Patients with unresectable LAPC can be included in the study. Prior to inclusion, initial treatment with chemotherapy with or without radiation therapy (RT) is administered to all patients accord to the referring institutions protocol. Some patients will have undergone an attempted resection prior to inclusion. It is expected, that a substantial number of patients are participants in the LAPC-03 protocol (FOLFIRINOX followed by local therapy (resection, RT and/or IRE) in patients with LAPC).
After completion of initial therapy, potential study participants are restaged with a PET-CT scan and serum tumor markers. Patients found on restaging to be free of metastatic disease and without significant primary tumor progression will be candidates for IRE therapy. IRE therapy will be administered not earlier than 2 weeks after completion of initial therapy.
IRE will be done under general anesthesia as an in-patient procedure. Patients will attend study specific visits with PET-CT scan 3, 6, 9, 12, 18 and 24 months post-IRE. Patients will attend the out-patient clinic after 1, 3, 6, 9, 12, 15, 18, 21 and 24 months. During this we will monitor pain, quality of life, global functioning and nutritional status.
In patients who, at any time during the study, are assessed as candidates for resection, a more detailed re-evaluation of resectability is performed according to local preferences (e.g. EUS and/or LAP/LUS and/or CT and/or MR).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patients in the study will be compared to data from clinical registry.|
|Masking:||None (Open Label)|
|Official Title:||Chemotherapy Followed by Irreversible Electroporation in Patients With Unresectable Locally Advanced Pancreatic Cancer (CHEMOFIRE-2)|
|Actual Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||May 2022|
|Estimated Study Completion Date :||May 2024|
in situ irreversible electroporation
Other Name: irreversible electroporation
- 2-year survival proportion from 1) diagnosis and 2) IRE [ Time Frame: 2 years after the last patient is enrolled ]
- Median overall survival from 1) diagnosis and 2) IRE [ Time Frame: 2 years after the last patient is enrolled ]
- Progression free survival after IRE [ Time Frame: 2 years after the last patient is enrolled ]
- Median time to local progression after IRE [ Time Frame: 2 years after the last patient is enrolled ]
- Median time to dissemination after IRE [ Time Frame: 2 years after the last patient is enrolled ]
- 90-day complication rate and severity (Clavien-Dindo) [ Time Frame: 90 days after the last patient is enrolled ]
- Resection rate [ Time Frame: 2 years after the last patient is enrolled ]
- Quality of life (EORTC QLQ C-30) [ Time Frame: Every 3 months for 2 years after the intervention ]Quality of life questionnaire - Core 30 is used to assess the quality of life in the included patients. Raw scores will be calculated according to the manual. Items will be grouped in: Global health status (range 0 - 100, high is good), Functional scales (range 0 - 100, high is good) and symptom scales (range 0 - 100 low is good). Differences in each scales during the course of the trial we be calculated seperately.
- Perioperative pain perception (VAS) [ Time Frame: Every week for 1 month after the intervention ]Perioperative pain will be scores using the visual analogue pain scale (range 0 - 10, low score is less pain).
- Long term pain perception (m-BPI-SF) [ Time Frame: Every 3 months for 2 years after the intervention ]Long term pain will be assessed using the modified Danish version of the Brief Pain Inventory - short form. The outcomes assessed will be an average score of pain severity items and interference items in accordance with the manual. The scales range from 0 to 10 (lower is less pain).
- ECOG performance status [ Time Frame: Every 3 months for 2 years after the intervention ]Physicians assessment of global functioning using the "Eastern Cooperative Oncology Group" perfomance status scale (range 0 - 5, low score is better)
- Nutritional status assessment (PG-SGA-SF) [ Time Frame: Every 3 months for 2 years after the intervention ]Nutritional status assessment using the Scored Patient-Generated Subjective Global Assessment (short form). The short form includes only patient reported measures and will be combined into a single score according to the manual (range 0 - 37,low score is better).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04093141
|Contact: Rasmus Virenfeldt Flak, MDemail@example.com|
|Contact: Mogens Tornby Stender, Consultant surgeon, PhDfirstname.lastname@example.org|
|Principal Investigator:||Ole Thorlacius-Ussing, Professor, DMSc||Department of gastrointestinal surgery, Aalborg University Hospital|