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2022-05-16
2028-12
2028-12
30
NCT05191940
EBG MedAustron GmbH
EBG MedAustron GmbH
INTERVENTIONAL
Radiotherapy for Locally Advanced Pancreatic Carcinomas (Phase II Trial)
This is an interventional, single-arm, open-label study with high dose short course radiotherapy for patients with locally advanced pancreatic cancer.
This is an interventional, open label, trial of definitive hypofractionated radiotherapy for patients with locally advanced pancreatic cancer. Within this study radiotherapy shall be delivered with active scanning particle-therapy using proton- or carbon ions radiotherapy. Particle therapy will be performed with a simultaneous integrated boost (SIB) treating a larger target volume, including elective lymph node stations and neural plexus, at a lower dose and boosting macroscopic disease. The investigator will explore the efficacy of these treatment in a real world scenario in which patients are allowed to receive standard systemic treatment and standard surgical treatment (if conversion to resectability is achieved). However, and in order to record and to gain better understanding of the influence of systemic therapies on the outcomes parameters of this study, patients will be sub-stratified in 3 groups: i) patients receiving FOLFIRINOX, ii) patients receiving Gemcitabine + Nanoparticle Albumin Bound Paclitaxel (NAB-Paclitaxel), iii) patients receiving other systemic therapies or not receiving antineoplastic systemic therapy.
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 |
|---|---|---|
2021-12-16 | N/A | 2025-05-07 |
2022-01-13 | N/A | 2025-05-08 |
2022-01-14 | N/A | 2025-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Other
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| OTHER: Particle radiotherapy According to the radiation plan using protons or carbon ions (between 25 and a maximum of 40 Gy). Planning Target Volume 1 : 25 Gy (Relative Biological Effectiveness) in 5 fractions of 5 Gy (Relative Biological Effectiveness) Planning Target Volume 2 : A | RADIATION: Particle-therapy using protons or carbon ions
DIAGNOSTIC_TEST: Blood sampling
DIAGNOSTIC_TEST: Magnetic resonance imaging
DIAGNOSTIC_TEST: Computertomography
DIAGNOSTIC_TEST: 18-F-FluorDesoxyGlukose Positron Emission Tomography-Computer Tomography (18F-FDG-PET-CT)
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Locoregional tumor control | Rate of locoregional tumor control at two year will be evaluated radiologically. This endpoint will be measured with the actuarial approach. | At two year |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Loco-regional progression-free survival | This endpoint will be measured with the actuarial approach. It will be assessed as the union of locoregional control and survival. Patient with loco regional recurrence will be considered failures. Deceased patient will also be considered failures. Patient lost to follow-up without evidence of locoregional recurrence will be censored. Distant metastasis and peritoneal carcinosis will be irrelevant respect to this endpoint. | 104 weeks after therapy |
| Overall survival | This endpoint will be measured with the actuarial approach. All deaths will be considered failures, patient lost to follow-up will be censored. | Maximal 109 weeks |
| Incidence of CTCAE v5.0 G4-5 toxicity | This endpoint will be scored as gross rate. The investigator will measure the number of patients experiencing at least one toxicity >= Grade 4 and >= Grade 5 and the number of events >= Grade 4 and >= Grade 5. The crude number will be divided by the total number of patients treated. | From enrollment to six months after radiation therapy initiation |
| Patient reported Health-related Quality of Life, measured with Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) | Quality of life will be measured with Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) before radiation therapy and at each follow-up. The FACT-Hep has 27 (+ a subscale with 18 additional) questions, each of which is answered using a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much). Questions are phrased so that higher numbers indicate a better health state, leading to some items being reverse-scored. Questions measure the respondents' health state over the last 7 days in four subscales: Physical Well-Being (7 questions), Social/Family Well-Being (7 questions), Emotional Well-Being (6 questions), and Functional Well-being (7 questions). This disease-specific version of the FACT-Hep contain these four core subscales, with additional (18) questions appended to address disease-specific factors. The higher the score the better the Quality of Life. | Maximal 109 weeks |
| Patient reported Health-related Quality of Life, measured with European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-C30 | Quality of life will be measured with EORTC Quality of Life Questionnaire-C30 before radiation therapy and at each follow-up. Questionnaire developed to assess the quality of life of cancer patients. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / quality of life (QoL) represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. | Maximal 109 weeks |
| Patient reported Health-related Quality of Life, measured with Brief Pain Inventory | Quality of life will be measured with Brief Pain Inventory before radiation therapy and at each follow-up. The Brief Pain Inventory (BPI) is a measurement tool for assessing clinical pain.The interference items were now presented with 0-10 scales, with 0=no interference and 10=interferes completely. | Maximal 109 weeks |
| Incidence of CTCAE v5.0 Grade 2 - Grade 5 acute, subacute and late toxicities | The number of events, their grade and their time course will be measured. | 104 weeks after therapy |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Piero Fossati, M.D. Phone Number: +43 664 80878 Email: piero.fossati@medaustron.at |
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:
18 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
