Pancreatic Ductal AdenocarcinomaPhase 4OINCNCT04480268
PAXG Out in the Country
A Phase 4 study testing PAXG regimen (cisplatin, nab-paclitaxel, capecitabine, gemcitabine) chemotherapy in people with Pancreatic Ductal Adenocarcinoma, run by IRCCS San Raffaele at 30 sites in Italy.
Trial summary
The objective of this study is to assess the reproducibility of PAXG regimen as first-line/primary chemotherapy in daily clinical practice in Pancreatic Ductal Adenocarcinoma (PDAC) borderline resectable, locally advanced or metastatic patients out of a large volume center. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- PAXG regimen (cisplatin, nab-paclitaxel, capecitabine, gemcitabine) chemotherapy
- How many people
- 175 participants
- Where
- 30 sitesItaly
- Study dates
- 8 Jul 2020to 1 Jan 2026
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cyto/histological diagnosis of pancreatic adenocarcinoma;
- locally advanced and metastatic disease corresponding to clinical stage III-IV according to TNM 8th Ed. 2017 and borderline resectable disease as anatomically defined according to NCCN Guidelines Version 1.2020 - Pancreatic Adenocarcinoma and biologically defined according to the International consensus on definition and criteria of borderline resectable pancreatic ductal adenocarcinoma 2017 (CA 19.9 > 500 IU/ml);
- ECOG Performance Status ≤1;
- adequate bone marrow function (GB ≥ 3500/mm3, neutrophils ≥1500/mm3, platelets ≥ 100000/mm3, Hb ≥10 g/dl), kidney function (serum creatinine < 1.5 mg/dL) and liver function (ALT and AST < 3 ULN and Serum total bilirubin ≤ 1.5 ULN);
- Patient of child-bearing potential must agree to use two medically acceptable methods of contraception (one for the patient and one for the partner) during the study and for 4 months after the last study treatment intake for women and 6 months for men;
- patients must have received at least 1 cycle (28 days) of the PAXG treatment for the disease within the timeframe starting from January 1 2020 to December 31st 2020 ;
- patient information and signed written informed consent.
Who cannot join
- previous chemotherapy treatment for recurrent disease;
- concurrent treatment with experimental drugs;
- presence of symptomatic brain metastases;
- heart failure, arrhythmia and/or acute myocardial infarction within 6 months prior to the beginning of PAXG treatment;
- women on pregnancy or lactation;
- history of interstitial lung disease;
- history of connective tissue diseases (systemic lupus erythematosus, systemic sclerosis, etc. ).
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
Italy30 sites, 30 recruiting
- Not yet recruiting
IRCCS Centro di Riferimento Oncologico (CRO)
Aviano
Angela Buonadonna, MD, abuonadonna@cro.it
- Not yet recruiting
Istituto dei tumori Giovanni Paolo II
Bari
Nicola Silvestris, MD, silvestrisnicola@gmail.com
- Not yet recruiting
AULSS 1 di Belluno
Belluno
Fable Zustovich, MD, fable.zustovich@aulss1.veneto.it
- Not yet recruiting
ASST Papa Giovanni XXIII
Bergamo
Barbara Merelli, MD, bmerelli@asst-pg23.it
- Not yet recruiting
Azienda Ospedaliera Policlinico Sant'Orsola-Malpighi
Bologna
Maria Cristina Di Marco, MD, PhD, mariacristina.dimarco@unibo.it
- Not yet recruiting
Azienda Ospedaliera AOU di Cagliari
Cagliari
Mario Scartozzi, MD, marioscartozzi@gmail.com
- Not yet recruiting
Ospedale di Carpi
Carpi
Ilaria Bernardini, MD, i.bernardini@ausl.mo.it
- Not yet recruiting
USL Toscana Nord Ovest
Carrara
Andrea Mambrini, MD, andrea.mambrini@uslnordovest.toscana.it
- Not yet recruiting
Fondazione Istituto Giglio
Cefalù
Massimiliano Spada, MD, maxspa75@yahoo.it
- Not yet recruiting
Ospedaliera Sant' Anna di Como Asst Lariana
Como
Monica Giordano, MD, monica.giordano@asst-lariana.it
- Not yet recruiting
Azienda Ospedaliera Universitaria Ospedali Riuniti di Foggia
Foggia
Matteo Landriscina, MD, PhD, matteo.landriscina@unifg.it
- Not yet recruiting
ASST Rhodense
Garbagnate
Silvia Della Torre, MD, sdellatorre@asst-rhodense.it
- Not yet recruiting
Ospedale Moriggia Pelascini
Gravedona
Giuseppe Valmadre, MD, gvalmadre@gmail.com
- Not yet recruiting
Irccs Irst
Meldola
Giovanni Luca Frassineti, MD, luca.frassineti@irst.emr.it
- Not yet recruiting
ASST Melegnano e Della Martesana
Melegnano
Andrea De Monte, MD, andrea.demonte@asst-melegnano-martesana.it
- Recruiting
IRCCS San Raffaele Medical Oncology Unit
Milan, 20132
Giulia Orsi, MD, +39 02 26437602, orsi.giulia@hsr.it
Maria Maddalena Valente, PhD, +39 02 26437623, valente.mariamaddalena@hsr.it
- Not yet recruiting
Istituto Oncologico Veneto IRCCS
Padova
Sara Lonardi, MD, sara.lonardi@iov.veneto.it
- Not yet recruiting
Ospedale Civico di Palermo
Palermo
Livio Blasi, MD, livio.blasi61@gmail.com
- Not yet recruiting
Azienda Ospedaliera di Parma
Parma
Ingrid Garajova, MD, PhD, igarajova@ao.pr.it
- Not yet recruiting
Azienda Ospedaliera di Piacenza
Piacenza
Luigi Cavanna, MD, l.cavanna@ausl.pc.it
- Not yet recruiting
Ospedale Generale Provinciale di Macerata
Province of Macerata
Luca Faloppi, MD, PhD, luca.faloppi@sanita.marche.it
- Not yet recruiting
Giovanni Paolo II-Maria Paternò
Ragusa
Stefano Cordio, MD, stefano.cordio@asp.rg.it
- Not yet recruiting
Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi D'Aragona
Salerno
Clementina Savastano, MD, savastano.clementina@tiscali.it
- Not yet recruiting
AULSS 4 Veneto Orientale
San Donà di Piave
Silvia Zanon, MD, silvia.zanon@aulss4.veneto.it
- Not yet recruiting
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo
Evaristo Maiello, MD, e.maiello@operapadrepio.it
- Not yet recruiting
Azienda Ospedaliera Ordine Mauriziano
Torino
Massimo Di Maio, MD, massimo.dimaio@unito.it
- Not yet recruiting
Presidio Ospedaliero Molinette
Torino
Maria Antonietta Satolli, MD, PhD, mariaantonietta.satolli@unito.it
- Not yet recruiting
Azienda Sanitaria Universitaria Integrata
Udine
Giovanni Gerardo Cardellino, MD, giovanni.cardellino@asufc.sanita.fvg.it
- Not yet recruiting
ASST Sette Laghi
Varese
Stefania Gobba, MD, stefaniamaria.gobba@asst-settelaghi.it
- Not yet recruiting
Ospedale San Bortolo Azienda ULSS8 Berica-Distretto Est
Vicenza
Giuseppe Aprile, MD, giuseppe.aprile@ulss8.veneto.it
About this study
The objective of this study is to assess the reproducibility of PAXG regimen as first-line/primary chemotherapy in daily clinical practice in Pancreatic Ductal Adenocarcinoma (PDAC) borderline resectable, locally advanced or metastatic patients out of a large volume center.
Read the detailed description
Pancreatic Ductal Adenocarcinoma (PDAC) is one of the most lethal malignancies, with a 5-year overall survival (OS) rate for all stages combined lower than 10%, decreasing to 3% in advanced disease. Additionally, PDAC is expected to become the 2nd leading cause for cancer-related death by 2030. Chemotherapy still represents the only therapeutic option in most cases, since 70% of PDAC patients exhibit metastatic or locally advanced disease at diagnosis. Concerning metastatic PDAC patients, combination chemotherapy has resulted in improved survival compared with single-agent treatment. Based on promising phase I/II studies, the PAXG regimen (cisplatin, nab-paclitaxel, capecitabine and gemcitabine) has been recommended for first-line treatment of metastatic PDAC patients in the 2019 edition of Associazione Italiana Oncologia Medica (AIOM) guidelines. Also, this regimen was approved by the Agenzia Italiana del Farmaco (AIFA) as first therapy of borderline-resectable, locally advanced and metastatic PDAC patients with good performance status (ECOG 0-1) and age 18-75 years.
Description of the intervention (schedule of visits):
All PDAC patients who are treated with PAXG regimen as first-line/primary chemotherapy at the participating institutions from January 1st 2020 to December 31st 2020 according to inclusion and exclusion criteria will be included in the present study.
Power size calculation:
The sample size will be as large as possible with a competitive enrollment. All patients treated by the PAXG regimen during 2020 in the participating institutions will be included into the trial. The investigators hypothesize that at least 175 patients (60% metastatic and 40% non-metastatic) from about 30 Italian centers will be enrolled by the end of the year. Such a sample size, or a larger one, will allow to compute in both groups a 95% confident interval of the 1-year OS with at least 10% margin of error, assuming to observe a (target) 1-year OS of 60% for metastatic patients and of 80% for non-metastatic. The trial will be considered successful if the target 1-year OS will fall into the corresponding computed 95% CI.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- PAXG regimen (cisplatin, nab-paclitaxel, capecitabine, gemcitabine) chemotherapy
- Keywords
- Combination chemotherapy, PAXG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAXG regimen (cisplatin, nab-paclitaxel, capecitabine, gemcitabine) chemotherapyDrug
The PAXG regimen includes:
- nab-paclitaxel 150 mg/m2 on day 1 and 15 of each cycle;
- cisplatin 30 mg/m2 on day 1 and 15 of each cycle;
- capecitabine 1250 mg/m2 on 1 day to 28 of each cycle;
- gemcitabine 800 mg/m2 on day 1 and 15 of each cycle. Each cycle lasts 28 days. Patients are treated until maximal response, disease progression or unacceptable toxicity.
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival at 1 year (PFS-1yr)
Primary aim of the study is to evaluate the proportion of patients alive after 1 year from registration
Measured: 12 months after the diagnosis
Secondary outcomes (5)
Biochemical Response
To evaluate the CA19-9 response rate
Measured: 12 months after the diagnosis
Radiological Response
To evaluate the RECIST radiological response
Measured: 12 months after the diagnosis
Toxicity profile
To evaluate drugs toxicity and safety according to according to the "Common Toxicity Criteria" defined by NCI (US) and integrated by NCIC (Canada) version 5.0
Measured: 12 months after the diagnosis
Progression-free survival (PFS)
To evaluate the progression-free survival (PFS), defined as the time between the date of registration and the date of documented radiological PD or death from any cause, whichever occurs first, or the date of last follow-up or last available tumour assessment if no further follow-up for disease progression is performed.
Measured: 5 year after the diagnosis
Overall Survival (OS)
To evaluate the overall survival (OS), defined as time between the date of registration and the date of death for any cause or the date they were last known to be alive.
Measured: 5 year after the diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start8 Jul 2020
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Reni, IRCCS San Raffaele
- Investigators
- Michele Reni, MD, Principal investigator, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480268
- Sponsor's protocol ID
- PACT31
- Acronym
- OINC
- Status last verified
- Feb 2021
- First submitted
- 14 Jul 2020
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reni M, Cereda S, Rognone A, Belli C, Ghidini M, Longoni S, Fugazza C, Rezzonico S, Passoni P, Slim N, Balzano G, Nicoletti R, Cappio S, Doglioni C, Villa E. A randomized phase II trial of two different 4-drug combinations in advanced pancreatic adenocarcinoma: cisplatin, capecitabine, gemcitabine plus either epirubicin or docetaxel (PEXG or PDXG regimen). Cancer Chemother Pharmacol. 2012 Jan;69(1):115-23. doi: 10.1007/s00280-011-1680-2. Epub 2011 May 28.
PubMed 21626049Reni M, Balzano G, Zanon S, Passoni P, Nicoletti R, Arcidiacono PG, Pepe G, Doglioni C, Fugazza C, Ceraulo D, Falconi M, Gianni L. Phase 1B trial of Nab-paclitaxel plus gemcitabine, capecitabine, and cisplatin (PAXG regimen) in patients with unresectable or borderline resectable pancreatic adenocarcinoma. Br J Cancer. 2016 Jul 26;115(3):290-6. doi: 10.1038/bjc.2016.209. Epub 2016 Jul 12.
PubMed 27404453Reni M, Zanon S, Peretti U, Chiaravalli M, Barone D, Pircher C, Balzano G, Macchini M, Romi S, Gritti E, Mazza E, Nicoletti R, Doglioni C, Falconi M, Gianni L. Nab-paclitaxel plus gemcitabine with or without capecitabine and cisplatin in metastatic pancreatic adenocarcinoma (PACT-19): a randomised phase 2 trial. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):691-697. doi: 10.1016/S2468-1253(18)30196-1. Epub 2018 Jul 7.
PubMed 30220407Reni M, Zanon S, Balzano G, Passoni P, Pircher C, Chiaravalli M, Fugazza C, Ceraulo D, Nicoletti R, Arcidiacono PG, Macchini M, Peretti U, Castoldi R, Doglioni C, Falconi M, Partelli S, Gianni L. A randomised phase 2 trial of nab-paclitaxel plus gemcitabine with or without capecitabine and cisplatin in locally advanced or borderline resectable pancreatic adenocarcinoma. Eur J Cancer. 2018 Oct;102:95-102. doi: 10.1016/j.ejca.2018.07.007. Epub 2018 Aug 24.
PubMed 30149366
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PAXG Out in the Country
- ClinicalTrials.gov ID
- NCT04480268
- Acronym / sponsor ID
- OINC / PACT31
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Keywords
- Combination chemotherapy, PAXG
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 21 Jul 2020 (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.
The objective of this study is to assess the reproducibility of PAXG regimen as first-line/primary chemotherapy in daily clinical practice in Pancreatic Ductal Adenocarcinoma (PDAC) borderline resectable, locally advanced or metastatic patients out of a large volume center.
Detailed description
Pancreatic Ductal Adenocarcinoma (PDAC) is one of the most lethal malignancies, with a 5-year overall survival (OS) rate for all stages combined lower than 10%, decreasing to 3% in advanced disease. Additionally, PDAC is expected to become the 2nd leading cause for cancer-related death by 2030. Chemotherapy still represents the only therapeutic option in most cases, since 70% of PDAC patients exhibit metastatic or locally advanced disease at diagnosis. Concerning metastatic PDAC patients, combination chemotherapy has resulted in improved survival compared with single-agent treatment. Based on promising phase I/II studies, the PAXG regimen (cisplatin, nab-paclitaxel, capecitabine and gemcitabine) has been recommended for first-line treatment of metastatic PDAC patients in the 2019 edition of Associazione Italiana Oncologia Medica (AIOM) guidelines. Also, this regimen was approved by the Agenzia Italiana del Farmaco (AIFA) as first therapy of borderline-resectable, locally advanced and metastatic PDAC patients with good performance status (ECOG 0-1) and age 18-75 years.
Description of the intervention (schedule of visits):
All PDAC patients who are treated with PAXG regimen as first-line/primary chemotherapy at the participating institutions from January 1st 2020 to December 31st 2020 according to inclusion and exclusion criteria will be included in the present study.
Power size calculation:
The sample size will be as large as possible with a competitive enrollment. All patients treated by the PAXG regimen during 2020 in the participating institutions will be included into the trial. The investigators hypothesize that at least 175 patients (60% metastatic and 40% non-metastatic) from about 30 Italian centers will be enrolled by the end of the year. Such a sample size, or a larger one, will allow to compute in both groups a 95% confident interval of the 1-year OS with at least 10% margin of error, assuming to observe a (target) 1-year OS of 60% for metastatic patients and of 80% for non-metastatic. The trial will be considered successful if the target 1-year OS will fall into the corresponding computed 95% CI.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- cyto/histological diagnosis of pancreatic adenocarcinoma;
- locally advanced and metastatic disease corresponding to clinical stage III-IV according to TNM 8th Ed. 2017 and borderline resectable disease as anatomically defined according to NCCN Guidelines Version 1.2020 - Pancreatic Adenocarcinoma and biologically defined according to the International consensus on definition and criteria of borderline resectable pancreatic ductal adenocarcinoma 2017 (CA 19.9 > 500 IU/ml);
- ECOG Performance Status ≤1;
- adequate bone marrow function (GB ≥ 3500/mm3, neutrophils ≥1500/mm3, platelets ≥ 100000/mm3, Hb ≥10 g/dl), kidney function (serum creatinine < 1.5 mg/dL) and liver function (ALT and AST < 3 ULN and Serum total bilirubin ≤ 1.5 ULN);
- Patient of child-bearing potential must agree to use two medically acceptable methods of contraception (one for the patient and one for the partner) during the study and for 4 months after the last study treatment intake for women and 6 months for men;
Key exclusion criteria (7 listed)
- previous chemotherapy treatment for recurrent disease;
- concurrent treatment with experimental drugs;
- presence of symptomatic brain metastases;
- heart failure, arrhythmia and/or acute myocardial infarction within 6 months prior to the beginning of PAXG treatment;
- women on pregnancy or lactation;
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 |
|---|---|---|
| PAXG regimen (cisplatin, nab-paclitaxel, capecitabine, gemcitabine) chemotherapyThe PAXG regimen includes: * nab-paclitaxel 150 mg/m2 on day 1 and 15 of each cycle; * cisplatin 30 mg/m2 on day 1 and 15 of each cycle; * capecitabine 1250 mg/m2 on 1 day to 28 of each cycle; * gemcitabine 800 mg/m2 on day 1 and 15 of each cycle. Each cycle lasts 28 days. Patients are treated until maximal response, disease progression or unacceptable toxicity. | Drug | – |
Primary outcome
Progression-free survival at 1 year (PFS-1yr)
Time frame: 12 months after the diagnosis
Primary aim of the study is to evaluate the proportion of patients alive after 1 year from registration
5 secondary outcomes
Biochemical Response
Time frame: 12 months after the diagnosis
Radiological Response
Time frame: 12 months after the diagnosis
Toxicity profile
Time frame: 12 months after the diagnosis
Progression-free survival (PFS)
Time frame: 5 year after the diagnosis
Overall Survival (OS)
Time frame: 5 year after the diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Background: PubMed 21626049Reni M, Cereda S, Rognone A, Belli C, Ghidini M, Longoni S, Fugazza C, Rezzonico S, Passoni P, Slim N, Balzano G, Nicoletti R, Cappio S, Doglioni C, Villa E. A randomized phase II trial of two different 4-drug combinations in advanced pancreatic adenocarcinoma: cisplatin, capecitabine, gemcitabine plus either epirubicin or docetaxel (PEXG or PDXG regimen). Cancer Chemother Pharmacol. 2012 Jan;69(1):115-23. doi: 10.1007/s00280-011-1680-2. Epub 2011 May 28.
- Background: PubMed 27404453Reni M, Balzano G, Zanon S, Passoni P, Nicoletti R, Arcidiacono PG, Pepe G, Doglioni C, Fugazza C, Ceraulo D, Falconi M, Gianni L. Phase 1B trial of Nab-paclitaxel plus gemcitabine, capecitabine, and cisplatin (PAXG regimen) in patients with unresectable or borderline resectable pancreatic adenocarcinoma. Br J Cancer. 2016 Jul 26;115(3):290-6. doi: 10.1038/bjc.2016.209. Epub 2016 Jul 12.
- Background: PubMed 30220407Reni M, Zanon S, Peretti U, Chiaravalli M, Barone D, Pircher C, Balzano G, Macchini M, Romi S, Gritti E, Mazza E, Nicoletti R, Doglioni C, Falconi M, Gianni L. Nab-paclitaxel plus gemcitabine with or without capecitabine and cisplatin in metastatic pancreatic adenocarcinoma (PACT-19): a randomised phase 2 trial. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):691-697. doi: 10.1016/S2468-1253(18)30196-1. Epub 2018 Jul 7.
- Background: PubMed 30149366Reni M, Zanon S, Balzano G, Passoni P, Pircher C, Chiaravalli M, Fugazza C, Ceraulo D, Nicoletti R, Arcidiacono PG, Macchini M, Peretti U, Castoldi R, Doglioni C, Falconi M, Partelli S, Gianni L. A randomised phase 2 trial of nab-paclitaxel plus gemcitabine with or without capecitabine and cisplatin in locally advanced or borderline resectable pancreatic adenocarcinoma. Eur J Cancer. 2018 Oct;102:95-102. doi: 10.1016/j.ejca.2018.07.007. Epub 2018 Aug 24.
- 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.
Michele Reni, MD principal investigator
IRCCS Ospedale San Raffaele
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PAXG regimen (cisplatin, nab-paclitaxel, capecitabine, gemcitabine) chemotherapy in people with Pancreatic Ductal Adenocarcinoma, run by IRCCS San Raffaele at 30 sites in Italy.
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 7 inclusion and 7 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 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Giulia Orsi, MD (+390226436620, orsi.giulia@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival at 1 year (PFS-1yr) (time frame: 12 months after the diagnosis). 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 NCT04480268, which also lists 4 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 10 Feb 2021.