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Following a decision by the industrial partner, it was decided to permanently close the study to new participants.
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This is a phase I/II, multicenter trial for patients with locally advanced and unresectable pancreatic tumours :
Patients included in Phase I will be monitored and included in the Phase II evaluation.
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.
Pancreatic adenocarcinomas are often diagnosed at an advanced stage and only 15% to 20% of patients are candidates for surgery to remove the tumour. In the remaining cases, around a third of patients have metastatic disease at the time of diagnosis. The remaining third have locally advanced pancreatic cancer. In these cases, chemotherapy with or without radiotherapy is the standard treatment. The low proportion of patients who can benefit from surgery and the poor response to chemotherapy make the development of new treatments vital and urgent.
For locally advanced cancers, we want to develop and evaluate a new form of treatment based on a medical device using high intensity focused ultrasound (HIFU), after chemotherapy.
HIFU is a recent technology that uses therapeutic ultrasound. All HIFU procedures currently performed are carried out using an extracorporeal approach.
The aim of this research is therefore to assess the safety and efficacy of HIFU ablation of locally advanced pancreatic tumours.
This trial is a two stages (phase I and II) open label non comparative study. The first step of this study is to evaluate the safety of the HIFU intervention on 3 to 6 patients included. Patients will be included one by one, with a safety committee after each intervention. The total number of patients included in phase I will depend on the complications rate : If no serious complications are observed among the first 3 patients treated, the phase II study can begin. If a serious complication is observed, 3 additional patients will be included in phase I. The transition to phase II will be effective if a maximum of 1 complication out of the 6 patients included is observed. In the other cases, if at least 2 serious complications are observed for 3 to 6 patients included, the study will be definitively stopped.
The second step of this study is to evaluate the efficacy of the HIFU intervention on 26 patients including the patients of phase I.
Each patient will be follow for two years after the HIFU intervention. Un update of vital status will be made annually until the last patient's last visit.
Sample size was thus evaluated by analogy with an A'Hern's. If at least 14 successes are observed among 26 patients, HIFU treatment will be considered of interest.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIFU intervention | Experimental | HIFU intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIFU intervention | Procedure | HIFU intervention on non resectable pancreatic lesions at day 0 for each patient included |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance profile of 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 | Up to 30 days after HIFU intervention |
| Survival rate at 12 months after HIFU intervention | The efficacy of treatment will be assessed by the proportion of patients alive 12 months after HIFU treatment | Up to 12 months after HIFU intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor ablation rate by HIFU | 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 | Up to 28 days after inclusion |
| Intra-operative and post-operative complications linked to the HIFU intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Estaing | Clermont-Ferrand | Auvergne-Rhône-Alpes | 63003 | France | ||
| Centre Léon Bérard |
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HIFU intervention at day 0 for each patient included.
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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 |
| Up to 3 months after HIFU intervention |
| Feasibility of HIFU intervention | 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. | Up to 28 days after inclusion |
| Progression-Free Survival (PFS) | 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 | 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 |
| Local Progression-Free Survival (local PFS) | 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 | From date of inclusion to the date of first disease progression or death or last update, assessed up to 60 months |
| Overall Survival (OS) | 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. | From date of inclusion to the date of death or date of last update, assessed up to 60 months |
| Length of hospitalization | 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 | From date of HIFU intervention to the date of discharge from hospitalization, assessed up to 3 months |
| Rehospitalization rate during the first 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 | From the date of HIFU intervention to 30 days after HIFU intervention |
| Rate of secondary resectability | 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 | From date of HIFU intervention to the date of last patient's last visit, assessed up to 60 months |
| Incidence and severity of adverse events | 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. | From the date of intervention to the date of last patient's last visit, assessed up to 60 months. |
| Quality of Life (QoL) | 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 scores and evolution of scores from inclusion to each time point. The QoL data will also be presented graphically. Questions 1 to 28 will be evaluated by a score from 1 to 4, 1 being the best outcome and 4 the worse and questions 29 and 30 will be evaluated by a score from 1 to 7, 1 being the worse outcome and 7 being the best. | From the date of inclusion to 6 months after HIFU intervention |
| Clinical benefice rate regarding pain | 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). | From the date of inclusion to the date of last patient's last visit, assessed up to 60 months. |
| Clinical benefice rate regarding weight | 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. | From the date of inclusion to the date of last patient's last visit, assessed up to 60 months. |
| Clinical benefice rate regarding performance status | 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. | From the date of inclusion to the date of last patient's last visit, assessed up to 60 months. |
| Lyon |
| Auvergne-Rhône-Alpes |
| 69008 |
| France |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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