Pancreatic Cancer Non-resectableNCT05262452
Concurrent FOLFIRINOX Plus High Intensity Focused Ultrasound for Pancreatic Cancer
A study testing ALPIUS 900, an ultrasound-guided high intensity focused ultrasound system and FOLFIRINOX regimen in people with Pancreatic Cancer Non-resectable and Chemotherapy Effect, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
In patients diagnosed with locally advanced pancreatic cancer (LAPC)/borderline resectable pancreatic cancer (BRPC) and planned chemotherapy using FOLFIRINOX, high intensity focused ultrasound (HIFU)/FOLFIRINOX combined treatment is performed on patients who agree to this study. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Pancreatic Cancer Non-resectable, Chemotherapy Effect, Ultrasound Therapy
- What is being tested?
- ALPIUS 900, an ultrasound-guided high intensity focused ultrasound system and FOLFIRINOX regimen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Aug 2021to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All of the following selection criteria must be met before participants can be registered for this clinical trial.
- Adults over 19-85
- Persons with a Karnofsky Performance Scale (KPS) of 70 percent or more;
- A person diagnosed as a tubular adenocarcinoma through biopsy.
- A person diagnosed with LAPC/BRPC by computed tomography (CT) or magnetic resonance imaging (MRI)
- A person willing to voluntarily agree to a clinical trial and comply with the test plan
Who cannot join
- The following exclusion criteria may not be registered in clinical trials.
- The presence of a cystic lesion within pancreatic cancer to be treated with HIFU or at the pancreas adjacent to the pancreatic cancer.
- The presence of a wide range of scar or surgical clips observed in the passage through the ultrasonic beam.
- In case proper ultrasound images for HIFU procedures are not shown
- A person who cannot lie down in a comfortable position.
- A person who has difficulty communicating
Show all 11Show fewer
- A person who has experience in toxic or hypersensitive reactions to FOLFIRINOX anticancer drugs.
- A person pregnant or breastfeeding
- Pancreatic cancer patients who have previously been anti-cancer treatment
- If severe side effects such as aortic rupture, duodenum perforation, gastrointestinal damage or intestinal necrosis are expected due to HIFU procedures.
- Other cases where participation in this clinical trial is judged inappropriate by the investigator (specific reasons should be recorded in the case report form)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Jae Young Lee, MD, 08220723073, leejy4u@snu.ac.kr
Soo Yeon Kang, CRC, 08220723073, jumper6805@gmail.com
About this study
Official title: Therapeutic Efficacy and Safety of Concurrent FOLFIRINOX Plus HIFU for Locally Advanced/Borderline Resectable Pancreatic Cancer: A Prospective Single-center, Single-arm, Investigator-initiated, Open-labeled, Exploratory Clinical Trial
In patients diagnosed with locally advanced pancreatic cancer (LAPC)/borderline resectable pancreatic cancer (BRPC) and planned chemotherapy using FOLFIRINOX, high intensity focused ultrasound (HIFU)/FOLFIRINOX combined treatment is performed on patients who agree to this study. The combined treatment group is treated in parallel with FOLFIRINOX and HIFU for the first four cycles and then CT is taken for reaction evaluation immediately, 2 months, and 4 months after the four-cycle treatment. For the response assessment, the response rate using RECIST ver. 1.1 and operable rate are evaluated and compared with the results of already established FOLFIRINOX single treatment in the investigators' institute. Time-to-progress and overall survival are calculated.
Read the detailed description
Patients diagnosed with pancreatic cancer through biopsy and diagnosed with LAPC/BRPC through computed tomography (CT) or magnetic resonance imaging (MRI) are referred to this clinical trial. When the referred patients are voluntarily signed a written consent form after hearing sufficient explanations related to this study, the referred patients will be registered for this clinical trial if all criteria for selection/exception are met.
A management log will be prepared for all subjects who have signed a clinical trial agreement and are registered in the study. These management logs are used to assign sequential subject numbers to subjects registered in clinical trials, and subject numbers are assigned 'screening numbers' and 'registration numbers'.
The subjects will visit on the scheduled date to receive chemotherapy and HIFU combined therapy and will be treated in accordance with the following treatment procedures and protocols.
<Visit 1 to Visit 4: Combined Treatment, Cycle 1, Cycle 2, Cycle 3, Cycle 4 ± 14 Days>
The subjects will receive combined treatments with anticancer drugs (FOLFIRINOX) and HIFU (ALPIUS 900) over four cycles over eight weeks. Afterwards, CT for reaction evaluation is taken immediately after 4 cycles (i.e., 2 months after the onset of combined treatment). CT is taken at intervals of two months up to 6 months after the onset of combined treatment.
At the end of each combined treatment, the patient will be observed about adverse events including anticancer drug adverse events and skin change and can be back home or hospitalized for one to two days after collecting blood for blood tests according to doctor's opinion.
<Schedule and procedures for combined treatment>
Perform a total of four treatments every two weeks for eight weeks.
Combined treatment procedure
Subjects are hospitalized and given anti-cancer drugs for about 50 hours in accordance with the standard protocol for anti-cancer treatment. If the medication is canceled or postponed due to the condition of the subject, the HIFU procedure will be canceled or postponed.
After the start of chemotherapy, receive HIFU treatment within 48 hours (30 minutes to 1 hour) and go up to the inpatient ward to monitor for 1 to 2 hours. If adverse events caused by anticancer drugs have not been recovered within 24 hours of administration or adverse events have not been fully recovered from previous HIFU procedures, the HIFU procedure may be canceled or postponed under the judgment of the investigator.
When combined treatment (anti-cancer drug administration) is completed, the subject shall be hospitalized for one to two days or return home depending on the physical condition of the subject.
<Treatment protocol>
Anti-cancer drug administration (FOLFIRINOX one time regimen) Oxaliplatin 85 mg/m2 (Intravenous, IV) Irinotecan 180 mg/m2 (Intravenous, IV) Leucovorin(Folic acid) 400 mg/m2 (Intravenous, IV) 5-fluorouracil 400 mg/m2 (IV push) 5-fluorouracil 2400 mg/m2 (Intravenous, IV) It is administered at the following schedule every two weeks. Day 1 : Oxaliplatin, Irinotecan, Leucovorin, 5-FU (IV-push), 5-FU (IV infusion) Day 2-3 : 5-FU (IV infusion)
The administration of anticancer drugs (FOLFIRINOX therapy) is applied equally to each treatment group and according to the institution's standard procedure. The FOLFIRINOX dose and administration cycle (interval) can be adjusted by the researcher's judgment depending on the condition and progress of the subject. Anti-cancer drugs used in clinical trials are licensed medicines and are used within the scope of permission.
<HIFU treatment (one-time treatment)>
The HIFU procedure is in accordance with the HIFU parameter, and the details of the pre-procedure, procedure, and post-procedure care of the subjects are in accordance with the manufacturer's ALPIUS 900 User Manual.
HIFU parameter
Acoustic Intensity 2.0 kilowatt (kW)/cm2, Duty cycle 1%, Exposure time 3 sec/point, Pulse repetition frequency (PRF) 10 Hz
Immediately, 2 months, and 4 months after completion of the 4th cycle combined treatment, the subjects visit the hospital to conduct the efficacy and safety assessment. The dose-limiting toxicity (DLT) or adverse device effect (ADE) assessment will be evaluated on each planned visit.
Treatment after the end of combined treatment of HIFU/Anticancer drug Subsequent treatment of patients who have completed HIFU/anti-cancer combined treatment in the first 4 cycles is determined and performed according to findings of CT performed after 4 cycles of combined treatment, overall physical condition of patients, and standard care guidelines. The implementation of surgery, continuation of FOLFIRINOX chemotherapy, conversion to other anticancer drugs, and further radiation therapy can be considered as possible treatments. This assessment is conducted after 8 and 12 cycles of treatment if the treatment continues for FOLFIRINOX chemotherapy, and further treatment policies are determined in accordance with the standard care guidelines. If surgery is performed after 8 or 12 cycles, additional cancer or radiotherapy may be performed after surgery according to surgery and pathological findings, and it is required to be determined in accordance with the standard care guidelines.
- Being tested
- ALPIUS 900, an ultrasound-guided high intensity focused ultrasound system, FOLFIRINOX regimen
- Keywords
- High-Intensity Focused Ultrasound Therapy,, Combined Modality Therapy, Clinical Trial, Neoadjuvant Therapy, Survival Analysis, pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALPIUS 900, an ultrasound-guided high intensity focused ultrasound systemDevice
Device to deliver mechanical stress and force to enhance drug delivery, using focused ultrasound
FOLFIRINOX regimenDrug
a chemotherapy regimen for treatment of advanced pancreatic cancer
- FOL : folinic acid (leucovorin), a vitamin B derivative that enhances the effects of 5-FU
- F : 5-FU, a pyrimidine analog and antimetabolite which incorporates into the DNA molecule and stops DNA synthesis
- IRIN : irinotecan (eloxatin), a platinum-based antineoplastic agent, which inhibits DNA repair and/or DNA synthesis.
- OX - oxaliplatin (Eloxatin), a platinum-based antineoplastic agent, which inhibits DNA repair and/or DNA synthesis
| Study group | Role | What they receive |
|---|---|---|
| CureHIFUPanc | Experimental | Patients diagnosed with locally advanced/borderline resectable pancreatic cancer through biopsy and CT/MRI imaging and planned to undergo anti-cancer treatment using FOLFIRINOX Receives: Device: ALPIUS 900, an ultrasound-guided high intensity focused ultrasound system; Drug: FOLFIRINOX regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-month Tumor Response
Based on CT findings taken immediately after completion of the four-cycle combined treatment (each cycle is 14 days), 2-month tumor response is evaluated with complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) according to the Response Evaluation Criteria In Solid Tumors (RECIST, Ver 1.1)
Measured: immediately after the completion of the four-cycle combined treatment (each cycle is 14 days)
4-month Tumor Response
Based on CT findings taken obtained 4 months after the start of combined treatment, 4-month tumor response is evaluated with complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) according to the Response Evaluation Criteria In Solid Tumors (RECIST, Ver 1.1)
Measured: 4 months after the start of combined treatment
6-month Tumor Response
Based on CT findings taken obtained 6 months after the start of combined treatment, 6-month tumor response is evaluated with complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) according to the Response Evaluation Criteria In Solid Tumors (RECIST, Ver 1.1)
Measured: 6 months after the start of combined treatment
Percentage of subjects that were subject to surgical resection
When surgery is determined according to American Joint Committee on Cancer (AJCC), 8 edition guidelines based on computed tomography (CT) images taken 4 months or 6 months after the start of the combined treatment, the percentage of subjects who were able to be operated on compared to the total number of registered subjects is calculated.
Measured: 4 months or 6 months after the start of the combined treatment
Secondary outcomes (2)
Time-to-Progression
The time taken from the date of diagnosis of pancreatic cancer or from the start date of combined treatment of pancreatic cancer until the date of first documented progression, assessed up to 24 months. Judging by RECIST ver. 1.1
Measured: from the date of diagnosis of pancreatic cancer or from the start date of combined treatment of pancreatic cancer until the date of first documented progression, assessed up to 24 month
Survival time
The time taken from the date of diagnosis of pancreatic cancer or the start date of combined treatment of pancreatic cancer until the date of death from any cause
Measured: from the date of diagnosis of pancreatic cancer or the start date of combined treatment of pancreatic cancer until the date of death from any cause, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start9 Aug 2021
- Primary completionMar 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Cancer Non-resectableStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients diagnosed with locally advanced/borderline resectable pancreatic cancer through biopsy and CT/MRI imaging and planned to undergo anti-cancer treatment using FOLFIRINOX
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Focused Ultrasound Foundation, Synex Consulting Ltd
- Responsible party
- Principal investigator, Jae Young Lee, Seoul National University Hospital
- Investigators
- Jae Young Lee, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262452
- Sponsor's protocol ID
- 2006-154-1135
- Status last verified
- Oct 2022
- First submitted
- 2 Oct 2021
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.
PubMed 21561347Conroy T, Hammel P, Hebbar M, Ben Abdelghani M, Wei AC, Raoul JL, Chone L, Francois E, Artru P, Biagi JJ, Lecomte T, Assenat E, Faroux R, Ychou M, Volet J, Sauvanet A, Breysacher G, Di Fiore F, Cripps C, Kavan P, Texereau P, Bouhier-Leporrier K, Khemissa-Akouz F, Legoux JL, Juzyna B, Gourgou S, O'Callaghan CJ, Jouffroy-Zeller C, Rat P, Malka D, Castan F, Bachet JB; Canadian Cancer Trials Group and the Unicancer-GI-PRODIGE Group. FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer. N Engl J Med. 2018 Dec 20;379(25):2395-2406. doi: 10.1056/NEJMoa1809775.
PubMed 30575490Murphy JE, Wo JY, Ryan DP, Jiang W, Yeap BY, Drapek LC, Blaszkowsky LS, Kwak EL, Allen JN, Clark JW, Faris JE, Zhu AX, Goyal L, Lillemoe KD, DeLaney TF, Fernandez-Del Castillo C, Ferrone CR, Hong TS. Total Neoadjuvant Therapy With FOLFIRINOX Followed by Individualized Chemoradiotherapy for Borderline Resectable Pancreatic Adenocarcinoma: A Phase 2 Clinical Trial. JAMA Oncol. 2018 Jul 1;4(7):963-969. doi: 10.1001/jamaoncol.2018.0329.
PubMed 29800971Choi YH, Lee SH, You MS, Shin BS, Paik WH, Ryu JK, Kim YT, Kwon W, Jang JY, Kim SW. Prognostic Factors for Patients with Borderline Resectable or Locally Advanced Pancreatic Cancer Receiving Neoadjuvant FOLFIRINOX. Gut Liver. 2021 Mar 15;15(2):315-323. doi: 10.5009/gnl19182.
PubMed 32235008Hackert T, Sachsenmaier M, Hinz U, Schneider L, Michalski CW, Springfeld C, Strobel O, Jager D, Ulrich A, Buchler MW. Locally Advanced Pancreatic Cancer: Neoadjuvant Therapy With Folfirinox Results in Resectability in 60% of the Patients. Ann Surg. 2016 Sep;264(3):457-63. doi: 10.1097/SLA.0000000000001850.
PubMed 27355262Wu F, Wang ZB, Zhu H, Chen WZ, Zou JZ, Bai J, Li KQ, Jin CB, Xie FL, Su HB. Feasibility of US-guided high-intensity focused ultrasound treatment in patients with advanced pancreatic cancer: initial experience. Radiology. 2005 Sep;236(3):1034-40. doi: 10.1148/radiol.2362041105. Epub 2005 Jul 29.
PubMed 16055692Vidal-Jove J, Perich E, Del Castillo MA. Ultrasound Guided High Intensity Focused Ultrasound for malignant tumors: The Spanish experience of survival advantage in stage III and IV pancreatic cancer. Ultrason Sonochem. 2015 Nov;27:703-706. doi: 10.1016/j.ultsonch.2015.05.026. Epub 2015 May 27.
PubMed 26044461Marinova M, Huxold HC, Henseler J, Mucke M, Conrad R, Rolke R, Ahmadzadehfar H, Rauch M, Fimmers R, Luechters G, Cuhls H, Radbruch L, Schild HH, Strunk H. Clinical Effectiveness and Potential Survival Benefit of US-Guided High-Intensity Focused Ultrasound Therapy in Patients with Advanced-Stage Pancreatic Cancer. Ultraschall Med. 2019 Oct;40(5):625-637. doi: 10.1055/a-0591-3386. Epub 2018 Apr 17.
PubMed 29665583Li T, Wang YN, Khokhlova TD, D'Andrea S, Starr F, Chen H, McCune JS, Risler LJ, Mashadi-Hossein A, Hingorani SR, Chang A, Hwang JH. Pulsed High-Intensity Focused Ultrasound Enhances Delivery of Doxorubicin in a Preclinical Model of Pancreatic Cancer. Cancer Res. 2015 Sep 15;75(18):3738-46. doi: 10.1158/0008-5472.CAN-15-0296. Epub 2015 Jul 27.
PubMed 26216548Lee ES, Lee JY, Kim H, Choi Y, Park J, Han JK, Choi BI. Pulsed high-intensity focused ultrasound enhances apoptosis of pancreatic cancer xenograft with gemcitabine. Ultrasound Med Biol. 2013 Nov;39(11):1991-2000. doi: 10.1016/j.ultrasmedbio.2013.06.004. Epub 2013 Aug 22.
PubMed 23972483Lee JY, Choi BI, Ryu JK, Kim YT, Hwang JH, Kim SH, Han JK. Concurrent chemotherapy and pulsed high-intensity focused ultrasound therapy for the treatment of unresectable pancreatic cancer: initial experiences. Korean J Radiol. 2011 Mar-Apr;12(2):176-86. doi: 10.3348/kjr.2011.12.2.176. Epub 2011 Mar 3.
PubMed 21430934Rapoport N, Payne A, Dillon C, Shea J, Scaife C, Gupta R. Focused ultrasound-mediated drug delivery to pancreatic cancer in a mouse model. J Ther Ultrasound. 2013 Jul 1;1:11. doi: 10.1186/2050-5736-1-11. eCollection 2013.
PubMed 25516800Park EJ, Ahn YD, Lee JY. In vivo study of enhanced chemotherapy combined with ultrasound image-guided focused ultrasound (USgFUS) treatment for pancreatic cancer in a xenograft mouse model. Eur Radiol. 2018 Sep;28(9):3710-3718. doi: 10.1007/s00330-018-5355-9. Epub 2018 Mar 29.
PubMed 29600477Yu MH, Lee JY, Kim HR, Kim BR, Park EJ, Kim HS, Han JK, Choi BI. Therapeutic Effects of Microbubbles Added to Combined High-Intensity Focused Ultrasound and Chemotherapy in a Pancreatic Cancer Xenograft Model. Korean J Radiol. 2016 Sep-Oct;17(5):779-88. doi: 10.3348/kjr.2016.17.5.779. Epub 2016 Aug 23.
PubMed 27587968Kim JH, Kim H, Kim YJ, Lee JY, Han JK, Choi BI. Dynamic contrast-enhanced ultrasonographic (DCE-US) assessment of the early response after combined gemcitabine and HIFU with low-power treatment for the mouse xenograft model of human pancreatic cancer. Eur Radiol. 2014 Sep;24(9):2059-68. doi: 10.1007/s00330-014-3260-4. Epub 2014 Jun 25.
PubMed 24962825
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Efficacy and Safety of Concurrent FOLFIRINOX Plus HIFU for Locally Advanced/Borderline Resectable Pancreatic Cancer: A Prospective Single-center, Single-arm, Investigator-initiated, Open-labeled, Exploratory Clinical Trial
- ClinicalTrials.gov ID
- NCT05262452
- Acronym / sponsor ID
- 2006-154-1135
- Keywords
- High-Intensity Focused Ultrasound Therapy,, Combined Modality Therapy, Clinical Trial, Neoadjuvant Therapy, Survival Analysis, pancreatic cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Focused Ultrasound Foundation, Synex Consulting Ltd
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In patients diagnosed with locally advanced pancreatic cancer (LAPC)/borderline resectable pancreatic cancer (BRPC) and planned chemotherapy using FOLFIRINOX, high intensity focused ultrasound (HIFU)/FOLFIRINOX combined treatment is performed on patients who agree to this study. The combined treatment group is treated in parallel with FOLFIRINOX and HIFU for the first four cycles and then CT is taken for reaction evaluation immediately, 2 months, and 4 months after the four-cycle treatment. For the response assessment, the response rate using RECIST ver. 1.1 and operable rate are evaluated and compared with the results of already established FOLFIRINOX single treatment in the investigators' institute. Time-to-progress and overall survival are calculated.
Detailed description
Patients diagnosed with pancreatic cancer through biopsy and diagnosed with LAPC/BRPC through computed tomography (CT) or magnetic resonance imaging (MRI) are referred to this clinical trial. When the referred patients are voluntarily signed a written consent form after hearing sufficient explanations related to this study, the referred patients will be registered for this clinical trial if all criteria for selection/exception are met.
A management log will be prepared for all subjects who have signed a clinical trial agreement and are registered in the study. These management logs are used to assign sequential subject numbers to subjects registered in clinical trials, and subject numbers are assigned 'screening numbers' and 'registration numbers'.
The subjects will visit on the scheduled date to receive chemotherapy and HIFU combined therapy and will be treated in accordance with the following treatment procedures and protocols.
<Visit 1 to Visit 4: Combined Treatment, Cycle 1, Cycle 2, Cycle 3, Cycle 4 ± 14 Days>
The subjects will receive combined treatments with anticancer drugs (FOLFIRINOX) and HIFU (ALPIUS 900) over four cycles over eight weeks. Afterwards, CT for reaction evaluation is taken immediately after 4 cycles (i.e., 2 months after the onset of combined treatment). CT is taken at intervals of two months up to 6 months after the onset of combined treatment.
At the end of each combined treatment, the patient will be observed about adverse events including anticancer drug adverse events and skin change and can be back home or hospitalized for one to two days after collecting blood for blood tests according to doctor's opinion.
<Schedule and procedures for combined treatment>
Perform a total of four treatments every two weeks for eight weeks.
Combined treatment procedure
Subjects are hospitalized and given anti-cancer drugs for about 50 hours in accordance with the standard protocol for anti-cancer treatment. If the medication is canceled or postponed due to the condition of the subject, the HIFU procedure will be canceled or postponed.
After the start of chemotherapy, receive HIFU treatment within 48 hours (30 minutes to 1 hour) and go up to the inpatient ward to monitor for 1 to 2 hours. If adverse events caused by anticancer drugs have not been recovered within 24 hours of administration or adverse events have not been fully recovered from previous HIFU procedures, the HIFU procedure may be canceled or postponed under the judgment of the investigator.
When combined treatment (anti-cancer drug administration) is completed, the subject shall be hospitalized for one to two days or return home depending on the physical condition of the subject.
<Treatment protocol>
Anti-cancer drug administration (FOLFIRINOX one time regimen) Oxaliplatin 85 mg/m2 (Intravenous, IV) Irinotecan 180 mg/m2 (Intravenous, IV) Leucovorin(Folic acid) 400 mg/m2 (Intravenous, IV) 5-fluorouracil 400 mg/m2 (IV push) 5-fluorouracil 2400 mg/m2 (Intravenous, IV) It is administered at the following schedule every two weeks. Day 1 : Oxaliplatin, Irinotecan, Leucovorin, 5-FU (IV-push), 5-FU (IV infusion) Day 2-3 : 5-FU (IV infusion)
The administration of anticancer drugs (FOLFIRINOX therapy) is applied equally to each treatment group and according to the institution's standard procedure. The FOLFIRINOX dose and administration cycle (interval) can be adjusted by the researcher's judgment depending on the condition and progress of the subject. Anti-cancer drugs used in clinical trials are licensed medicines and are used within the scope of permission.
<HIFU treatment (one-time treatment)>
The HIFU procedure is in accordance with the HIFU parameter, and the details of the pre-procedure, procedure, and post-procedure care of the subjects are in accordance with the manufacturer's ALPIUS 900 User Manual.
HIFU parameter
Acoustic Intensity 2.0 kilowatt (kW)/cm2, Duty cycle 1%, Exposure time 3 sec/point, Pulse repetition frequency (PRF) 10 Hz
Immediately, 2 months, and 4 months after completion of the 4th cycle combined treatment, the subjects visit the hospital to conduct the efficacy and safety assessment. The dose-limiting toxicity (DLT) or adverse device effect (ADE) assessment will be evaluated on each planned visit.
Treatment after the end of combined treatment of HIFU/Anticancer drug Subsequent treatment of patients who have completed HIFU/anti-cancer combined treatment in the first 4 cycles is determined and performed according to findings of CT performed after 4 cycles of combined treatment, overall physical condition of patients, and standard care guidelines. The implementation of surgery, continuation of FOLFIRINOX chemotherapy, conversion to other anticancer drugs, and further radiation therapy can be considered as possible treatments. This assessment is conducted after 8 and 12 cycles of treatment if the treatment continues for FOLFIRINOX chemotherapy, and further treatment policies are determined in accordance with the standard care guidelines. If surgery is performed after 8 or 12 cycles, additional cancer or radiotherapy may be performed after surgery according to surgery and pathological findings, and it is required to be determined in accordance with the standard care guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients diagnosed with locally advanced/borderline resectable pancreatic cancer through biopsy and CT/MRI imaging and planned to undergo anti-cancer treatment using FOLFIRINOX
| Arm | Type | Receives |
|---|---|---|
| CureHIFUPanc | Experimental | Device: ALPIUS 900, an ultrasound-guided high intensity focused ultrasound system, Drug: FOLFIRINOX regimenPatients diagnosed with locally advanced/borderline resectable pancreatic cancer through biopsy and CT/MRI imaging and planned to undergo anti-cancer treatment using FOLFIRINOX |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All of the following selection criteria must be met before participants can be registered for this clinical trial.
- Adults over 19-85
- Persons with a Karnofsky Performance Scale (KPS) of 70 percent or more;
- A person diagnosed as a tubular adenocarcinoma through biopsy.
- A person diagnosed with LAPC/BRPC by computed tomography (CT) or magnetic resonance imaging (MRI)
Key exclusion criteria (11 listed)
- The following exclusion criteria may not be registered in clinical trials.
- The presence of a cystic lesion within pancreatic cancer to be treated with HIFU or at the pancreas adjacent to the pancreatic cancer.
- The presence of a wide range of scar or surgical clips observed in the passage through the ultrasonic beam.
- In case proper ultrasound images for HIFU procedures are not shown
- A person who cannot lie down in a comfortable position.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALPIUS 900, an ultrasound-guided high intensity focused ultrasound systemDevice to deliver mechanical stress and force to enhance drug delivery, using focused ultrasound | Device | CureHIFUPanc |
| FOLFIRINOX regimena chemotherapy regimen for treatment of advanced pancreatic cancer * FOL : folinic acid (leucovorin), a vitamin B derivative that enhances the effects of 5-FU * F : 5-FU, a pyrimidine analog and antimetabolite which incorporates into the DNA molecule and stops DNA synthesis * IRIN : irinotecan (eloxatin), a platinum-based antineoplastic agent, which inhibits DNA repair and/or DNA synthesis. * OX - oxaliplatin (Eloxatin), a platinum-based antineoplastic agent, which inhibits DNA repair and/or DNA synthesis | Drug | CureHIFUPanc |
Primary outcome
2-month Tumor Response
Time frame: immediately after the completion of the four-cycle combined treatment (each cycle is 14 days)
Based on CT findings taken immediately after completion of the four-cycle combined treatment (each cycle is 14 days), 2-month tumor response is evaluated with complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) according to the Response Evaluation Criteria In Solid Tumors (RECIST, Ver 1.1)
4-month Tumor Response
Time frame: 4 months after the start of combined treatment
Based on CT findings taken obtained 4 months after the start of combined treatment, 4-month tumor response is evaluated with complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) according to the Response Evaluation Criteria In Solid Tumors (RECIST, Ver 1.1)
6-month Tumor Response
Time frame: 6 months after the start of combined treatment
Based on CT findings taken obtained 6 months after the start of combined treatment, 6-month tumor response is evaluated with complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) according to the Response Evaluation Criteria In Solid Tumors (RECIST, Ver 1.1)
Percentage of subjects that were subject to surgical resection
Time frame: 4 months or 6 months after the start of the combined treatment
When surgery is determined according to American Joint Committee on Cancer (AJCC), 8 edition guidelines based on computed tomography (CT) images taken 4 months or 6 months after the start of the combined treatment, the percentage of subjects who were able to be operated on compared to the total number of registered subjects is calculated.
2 secondary outcomes
Time-to-Progression
Time frame: from the date of diagnosis of pancreatic cancer or from the start date of combined treatment of pancreatic cancer until the date of first documented progression, assessed up to 24 month
Survival time
Time frame: from the date of diagnosis of pancreatic cancer or the start date of combined treatment of pancreatic cancer until the date of death from any cause, assessed up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Background: PubMed 21561347Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.
- Background: PubMed 30575490Conroy T, Hammel P, Hebbar M, Ben Abdelghani M, Wei AC, Raoul JL, Chone L, Francois E, Artru P, Biagi JJ, Lecomte T, Assenat E, Faroux R, Ychou M, Volet J, Sauvanet A, Breysacher G, Di Fiore F, Cripps C, Kavan P, Texereau P, Bouhier-Leporrier K, Khemissa-Akouz F, Legoux JL, Juzyna B, Gourgou S, O'Callaghan CJ, Jouffroy-Zeller C, Rat P, Malka D, Castan F, Bachet JB; Canadian Cancer Trials Group and the Unicancer-GI-PRODIGE Group. FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer. N Engl J Med. 2018 Dec 20;379(25):2395-2406. doi: 10.1056/NEJMoa1809775.
- Background: PubMed 29800971Murphy JE, Wo JY, Ryan DP, Jiang W, Yeap BY, Drapek LC, Blaszkowsky LS, Kwak EL, Allen JN, Clark JW, Faris JE, Zhu AX, Goyal L, Lillemoe KD, DeLaney TF, Fernandez-Del Castillo C, Ferrone CR, Hong TS. Total Neoadjuvant Therapy With FOLFIRINOX Followed by Individualized Chemoradiotherapy for Borderline Resectable Pancreatic Adenocarcinoma: A Phase 2 Clinical Trial. JAMA Oncol. 2018 Jul 1;4(7):963-969. doi: 10.1001/jamaoncol.2018.0329.
- Background: PubMed 32235008Choi YH, Lee SH, You MS, Shin BS, Paik WH, Ryu JK, Kim YT, Kwon W, Jang JY, Kim SW. Prognostic Factors for Patients with Borderline Resectable or Locally Advanced Pancreatic Cancer Receiving Neoadjuvant FOLFIRINOX. Gut Liver. 2021 Mar 15;15(2):315-323. doi: 10.5009/gnl19182.
- Background: PubMed 27355262Hackert T, Sachsenmaier M, Hinz U, Schneider L, Michalski CW, Springfeld C, Strobel O, Jager D, Ulrich A, Buchler MW. Locally Advanced Pancreatic Cancer: Neoadjuvant Therapy With Folfirinox Results in Resectability in 60% of the Patients. Ann Surg. 2016 Sep;264(3):457-63. doi: 10.1097/SLA.0000000000001850.
- Background: PubMed 16055692Wu F, Wang ZB, Zhu H, Chen WZ, Zou JZ, Bai J, Li KQ, Jin CB, Xie FL, Su HB. Feasibility of US-guided high-intensity focused ultrasound treatment in patients with advanced pancreatic cancer: initial experience. Radiology. 2005 Sep;236(3):1034-40. doi: 10.1148/radiol.2362041105. Epub 2005 Jul 29.
- Background: PubMed 26044461Vidal-Jove J, Perich E, Del Castillo MA. Ultrasound Guided High Intensity Focused Ultrasound for malignant tumors: The Spanish experience of survival advantage in stage III and IV pancreatic cancer. Ultrason Sonochem. 2015 Nov;27:703-706. doi: 10.1016/j.ultsonch.2015.05.026. Epub 2015 May 27.
- Background: PubMed 29665583Marinova M, Huxold HC, Henseler J, Mucke M, Conrad R, Rolke R, Ahmadzadehfar H, Rauch M, Fimmers R, Luechters G, Cuhls H, Radbruch L, Schild HH, Strunk H. Clinical Effectiveness and Potential Survival Benefit of US-Guided High-Intensity Focused Ultrasound Therapy in Patients with Advanced-Stage Pancreatic Cancer. Ultraschall Med. 2019 Oct;40(5):625-637. doi: 10.1055/a-0591-3386. Epub 2018 Apr 17.
- Background: PubMed 26216548Li T, Wang YN, Khokhlova TD, D'Andrea S, Starr F, Chen H, McCune JS, Risler LJ, Mashadi-Hossein A, Hingorani SR, Chang A, Hwang JH. Pulsed High-Intensity Focused Ultrasound Enhances Delivery of Doxorubicin in a Preclinical Model of Pancreatic Cancer. Cancer Res. 2015 Sep 15;75(18):3738-46. doi: 10.1158/0008-5472.CAN-15-0296. Epub 2015 Jul 27.
- Background: PubMed 23972483Lee ES, Lee JY, Kim H, Choi Y, Park J, Han JK, Choi BI. Pulsed high-intensity focused ultrasound enhances apoptosis of pancreatic cancer xenograft with gemcitabine. Ultrasound Med Biol. 2013 Nov;39(11):1991-2000. doi: 10.1016/j.ultrasmedbio.2013.06.004. Epub 2013 Aug 22.
- Background: PubMed 21430934Lee JY, Choi BI, Ryu JK, Kim YT, Hwang JH, Kim SH, Han JK. Concurrent chemotherapy and pulsed high-intensity focused ultrasound therapy for the treatment of unresectable pancreatic cancer: initial experiences. Korean J Radiol. 2011 Mar-Apr;12(2):176-86. doi: 10.3348/kjr.2011.12.2.176. Epub 2011 Mar 3.
- Background: PubMed 25516800Rapoport N, Payne A, Dillon C, Shea J, Scaife C, Gupta R. Focused ultrasound-mediated drug delivery to pancreatic cancer in a mouse model. J Ther Ultrasound. 2013 Jul 1;1:11. doi: 10.1186/2050-5736-1-11. eCollection 2013.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae Young Lee, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALPIUS 900, an ultrasound-guided high intensity focused ultrasound system and FOLFIRINOX regimen in people with Pancreatic Cancer Non-resectable and Chemotherapy Effect, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Soo Yeon Kang, CRC (82-2-2072-3073, jumper6805@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-month Tumor Response (time frame: immediately after the completion of the four-cycle combined treatment (each cycle is 14 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05262452, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.