Evaluation of the High Intensity Focused Ultrasound (HIFU) Technique for Patients With Unresectable Pancreatic Tumor Treatment (PULS)

Registration Number
NCT06211933
Lead Sponsor
Centre Leon Berard
Brief Summary

This is a phase I/II, multicenter trial for patients with locally advanced and unresectable pancreatic tumours :

* A Phase I evaluating the tolerance of intraoperative High Intensity Focused Ultrasound (HIFU) intervention on the pancreatic lesion.
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Detailed Description

The PULS study is designed for patients with a locally advanced tumour of the pancreas (known as pancreatic adenocarcinoma) that has previously been treated with several cycles of chemotherapy and cannot be removed by surgery.
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Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
26
Inclusion Criteria
  • Age ≥ 18 years at the day of consenting to the study
  • Patient with histologically confirmed locally advanced (unresectable) pancreatic adenocarcinoma according to the National Comprehensive Cancer Network (NCCN) 2020 classification
  • Unifocal pancreatic lesion with a maximum diameter of 4 cm
  • Non-progressive disease after 4 months of first-line chemotherapy or after 2 months of chemotherapy in case of limiting toxicity contraindicating continuation of chemotherapy;
  • Preoperative imaging including CT-scan, MRI of the liver and Positron Emission Computed Tomography scan (PET-CT scan) (except for absolute medical contraindications), within 4 weeks prior to HIFU treatment
  • Eastern Cooperative Oncology Group performance status ≤ 2
  • Adequate hematologic parameters defined by platelets ≥ 100 Giga/l and hemoglobin ≥ 8 g/dl
  • Ability to understand and willingness for follow-up visits
  • Patient affiliated to a health insurance scheme (or beneficiary of such a scheme)
  • Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment
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Exclusion Criteria
  • Local recurrence of previously operated pancreatic cancer
  • Metastatic pancreatic carcinoma
  • History of major pancreatic resection
  • Chemotherapy completed less than 2 weeks ago
  • History of radiotherapy to the pancreas
  • Pregnant women
  • Possibility of R0 resection with venous reconstruction
  • Inability to undergo study follow-up for geographical, social or psychological reasons
  • Patient requiring tutorship or curatorship or patient deprived of liberty
  • Patient under psychiatric care against his wishes
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
HIFU interventionHIFU interventionHIFU intervention
Primary Outcome Measures
NameTimeMethod
Tolerance profile of HIFU interventionUp to 30 days after HIFU intervention

The tolerance of HIFU intervention will be assessed by the number of patients presenting at least one serious complication during the first 30 days after HIFU intervention. A serious complication corresponds either to any grade 3 or more complication according Clavien-Dindo classification or any vascular complication treated by interventional radiology

Survival rate at 12 months after HIFU interventionUp to 12 months after HIFU intervention

The efficacy of treatment will be assessed by the proportion of patients alive 12 months after HIFU treatment

Secondary Outcome Measures
NameTimeMethod
Intra-operative and post-operative complications linked to the HIFU interventionUp to 3 months after HIFU intervention

The Intra-operative and post-operative complications linked to the HIFU intervention will be evaluated by the number of patients with at least one complication according to Clavien Dindo classification appeared during HIFU intervention and until 3 months after HIFU intervention

Feasibility of HIFU interventionUp to 28 days after inclusion

The feasibility of HIFU intervention will be evaluated by the rate of patients who were able to benefit from HIFU intervention. The reasons for non-completion will be described.

Tumor ablation rate by HIFUUp to 28 days after inclusion

The tumor ablation rate by HIFU is defined by the volume of the area destroyed by HIFU compared to the volume of the pancreatic cancer on the imaging

Rate of secondary resectabilityFrom date of HIFU intervention to the date of last patient's last visit, assessed up to 60 months

The secondary resectability will be calculated by the number of patients eligible for curative pancreatic resection following HIFU intervention compared to the total number of patients who received HIFU intervention

Clinical benefice rate regarding weightFrom the date of inclusion to the date of last patient's last visit, assessed up to 60 months.

The clinical benefice rate regarding weight will be calculated by the number of patients showing an improvement in weight (in kilograms) from inclusion to the end of study, compared to the total number of patients who received HIFU intervention. A 10% or more increase of weight will be considered as a weight improvement.

Clinical benefice rate regarding performance statusFrom the date of inclusion to the date of last patient's last visit, assessed up to 60 months.

The clinical benefice rate regarding performance status will be calculated by the number of patients showing an improvement in performance status from inclusion to the end of study, compared to the total number of patients who received HIFU intervention. Performance status will be assessed by the Eastern Cooperative Group of Oncology (ECOG) score.

Progression-Free Survival (PFS)From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first or until the date of the last update for patients without progression, assessed up to 60 months after inclusion

The Progression-Free Survival (PFS) will be defined as the time from the date of HIFU intervention to the date of first documented disease progression or the date of death due to any cause or until the date of the last update for patients without progression

Local Progression-Free Survival (local PFS)From date of inclusion to the date of first disease progression or death or last update, assessed up to 60 months

The local Progression-Free Survival (local PFS) will be defined as the time from the date of HIFU intervention to the date of first local progression

Rehospitalization rate during the first 30 days after HIFU intervention.From the date of HIFU intervention to 30 days after HIFU intervention

The rehospitalization rate during the first 30 days after HIFU intervention will be calculated by the number of patients rehospitalized during the first 30 days after HIFU intervention compared to the total number of patients who received HIFU intervention

Incidence and severity of adverse eventsFrom the date of intervention to the date of last patient's last visit, assessed up to 60 months.

Descriptive statistics will be used to describe the tolerance profile to HIFU intervention. The incidence and severity of adverse events (AEs), HIFU procedure-related AEs, Serious Adverse Events (SAEs), and deaths will be graded according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) classification.

Quality of Life (QoL)From the date of inclusion to 6 months after HIFU intervention

The patient's Quality of Life (QoL) will be assessed using the European Organisation for Research and Treatment of Cancer (EORTC) Quality Of Life Questionnaire C30 file. The questionnaire includes 30 questions whose scores will be calculated at each time point according to the scoring manuals of EORTC. Descriptive statistics will be used to evaluate baseline...

Overall Survival (OS)From date of inclusion to the date of death or date of last update, assessed up to 60 months

The Overall Survival (OS) will be defined as the time from date of HIFU intervention to the date of death, from any cause. Patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.

Length of hospitalizationFrom date of HIFU intervention to the date of discharge from hospitalization, assessed up to 3 months

The length of hospitalization will be calculated by number of days from the date of the HIFU intervention until the date of discharge from hospitalization

Clinical benefice rate regarding painFrom the date of inclusion to the date of last patient's last visit, assessed up to 60 months.

The clinical benefice rate regarding pain will be calculated by the number of patients showing an improvement in pain from inclusion to the end of study, compared to the total number of patients who received HIFU intervention. Pain will be assessed by an analog visual scale (0 to 10 scale, 0 being the best score and 10 the worse).

Trial Locations

Locations (2)

CHU Estaing

🇫🇷

Clermont-Ferrand, Auvergne Rhone-Alpes, France

Centre Léon Bérard

🇫🇷

Lyon, Rhone-alpes, France

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