Pancreatic AdenocarcinomaPhase 2/3NCT05181605
Survival Analysis After Neoadjuvant Therapy in Patients With Resectable Pancreatic Cancer and Risk Factors
A Phase 2/3 study testing Folfirinox and Stereotactic Body Radiotherapy in people with Pancreatic Adenocarcinoma and Pancreatic Cancer Resectable, run by Instituto de investigación e innovación biomédica de Cádiz at 1 site in Spain.
Trial summary
Resectable Pancreatic Cancer represents an important health problem not because of its incidence, but because of its high mortality. Diagnosis in the initial stages is difficult, since the first symptoms of disease are often nonspecific. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatic Adenocarcinoma, Pancreatic Cancer Resectable
- What is being tested?
- Folfirinox and Stereotactic Body Radiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteSpain
- Study dates
- 15 Apr 2022to 1 Dec 2024
- Phase
- Phase 2/3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients diagnosed with resectable pancreatic adenocarcinoma plus risk factors
- 2. Histological diagnosis of pancreatic adenocarcinoma by fine needle aspiration (FNA) performed by Echoendoscopy.
- 3. Patients who have not received prior therapy for pancreatic cancer.
- 4. Biliary drainage prior to neoadjuvant treatment.
- 5. Age> 18 years and <70 years.
- 6. No history of cerebrovascular accident (CVA) or myocardial infarction (MI) in 6 months prior to neoadjuvant treatment.
Show all 9Show fewer
- 7. Women of childbearing potential and sexually active men must agree to the use of appropriate contraceptive methods (hormonal, barrier, or abstinence) prior to study enrollment and during study participation.
- 8. Patients should have normal organs and spinal function.
- 9. Ability to understand, and willingness to sign a written informed consent document
Who cannot join
- 1. Patients with resectable pancreatic adenocarcinoma without risk factors.
- 2. Patients with borderline pancreatic adenocarcinoma.
- 3. Patients with locally advanced pancreatic adenocarcinoma.
- 4. Patients with metastatic adenocarcinoma of the pancreas.
- 5. Patients who have received prior chemotherapy or radiotherapy for pancreatic adenocarcinoma
- 6. Pathological subtypes other than adenocarcinoma.
Show all 13Show fewer
- 7. Patients included in a clinical trial in a period of 6 months prior to inclusion in this study.
- 8. A past history of allergic reaction attributed to 5-FU, leucovorin, Irinotecan or Oxaliplatin or to compounds of similar chemical or biological composition.
- 9. Uncontrolled breakthrough disease.
- 10. Patients with HIV, HBV and HCV positive and currently under antiretroviral therapy.
- 11. Other active malignancies
- 12. Pre-existing neuropathy, grade > 1.
- 13. Inflammatory bowel disease that is not controlled, or under current active therapy.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Puerta del Mar
Cadiz, 11010
Mª Jesus Castro Santiago, +34 956 002151
Santi, +34 956 019042
About this study
Resectable Pancreatic Cancer represents an important health problem not because of its incidence, but because of its high mortality. Diagnosis in the initial stages is difficult, since the first symptoms of disease are often nonspecific. Only 15 - 25% of patients would undergo surgery with curative resection at the time of initial diagnosis. There is no an effective screening test for early diagnosis. A characteristic that defines the pancreatic adenocarcinoma is its aggressiveness. There is a high prevalence of patients who present metastatic disease at the time of diagnosis, therefore, it is evident that this tumor is capable of early systemic spread. Starting from the high prevalence of patients who experience metastatic disease shortly after undergoing a potentially curative resection, it is likely that at the time of diagnosis, the majority of pancreatic adenocarcinomas have progressed to systemic spread. The overall 5-year survival of the patients is 5.8% and has not increased in the last 10 years; the 5-year survival rate after curative surgery is not higher (7%). Patients with resectable adenocarcinoma of the pancreas, only 15% are diagnosed at an early stage (T1, T2 without lymph node involvement), these are associated with improved survival. The surgery required to treat pancreatic cancer is aggressive. To optimize results, you need to follow a series of guidelines strictly. The current standard treatment regimen for resectable pancreatic adenocarcinoma is based on surgery plus adjuvant chemotherapy. With all this, the survival rate at five years after surgery is not greater than 7%, and in addition, there is a high percentage of patients who experience metastatic disease after surgical resection with curative intent. This indicates that at the time of diagnosis, it is likely that most adenocarcinomas pancreatic diseases have progressed to systemic spread. For this reason, for years there is a growing interest in investigating new therapeutic approaches, such as the role of neoadjuvant therapy.
Read the detailed description
Disease: Pancreatic cancer resectable plus risk factors
Hypothesis: The overall survival in patients treated with neoadjuvant chemotherapy before surgery -resection- plus adjuvant chemotherapy is higher than in patients treated per standard of care (only with adjuvant chemotherapy after surgery)
Objectives:
Main objective: To assess overall survival in patients treated with neoadjuvant chemotherapy before surgery-resection and adjuvant chemotherapy vs patients treated only with adjuvant chemotherapy after surgery-
Secondary objectives: To assess in both patients (experimental vs control arms): - Progression free survival - Number of completed cycles fo chemotherapy - Local and metastatic recurrence - Post-surgical morbidity - Resection rate R0 - Safety of the neoadjuvant chemotherapy
- Being tested
- Folfirinox and Stereotactic Body Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folfirinox and Stereotactic Body RadiotherapyDrug
Neoadjuvant treatment is composed of folfirinox plus stereotactic body radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| No Intervention: No intervention - standard of care | No intervention | A group of patients with pancreatic carcinoma plus risk factors will be treated per standard of care on site (surgical resection and adjuvant therapy) |
| Experimental: Neoadyuvant therapy plus standard of care | Experimental | A group of patients with pancreatic carcinoma plus risk factors will be treated with neoadjuvant therapy before surgical resection and adjuvant therapy Receives: Drug: Folfirinox and Stereotactic Body Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Weeks until death
Measured: through study completion, an average of 3 year
Secondary outcomes (6)
Period until recurrence disease
Weeks until progression disease (local or metastatic recurrence)
Measured: through study completion, an average of 3 year
Number of completed chemotherapy cycles
Number of completed chemotherapy cycles
Measured: during chemiotherapy completion, an average of 3 year
Progression disease
Progression disease per RECIST 1.1
Measured: through study completion, an average of 3 year
Post-surgical events (if any)
physiological parameter for post-surgical events (if any)
Measured: through post-surgical period (6 months)
Post-surgical events (if any)
Number of post-surgical events (if any)
Measured: through post-surgical period (6 months)
Adverse events
Type and number of adverse events.
Measured: through study completion, including follow up period, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start15 Apr 2022
- Primary completion15 Apr 2023 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de investigación e innovación biomédica de Cádiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- María Jesús Castro Santiago, Study director, Hospital Universitario Puerta del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181605
- Sponsor's protocol ID
- ICI20-00047
- Status last verified
- Nov 2021
- First submitted
- 8 Nov 2021
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study results will be published in scientific oncologyc journal and available in PubMed and clinicaltrials websites
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival Analysis After Neoadjuvant Therapy in Patients With Resectable Pancreatic Cancer and Risk Factors
- ClinicalTrials.gov ID
- NCT05181605
- Acronym / sponsor ID
- ICI20-00047
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Instituto de investigación e innovación biomédica de CádizUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 15 Apr 2023 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 6 Jan 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.
Resectable Pancreatic Cancer represents an important health problem not because of its incidence, but because of its high mortality. Diagnosis in the initial stages is difficult, since the first symptoms of disease are often nonspecific. Only 15 - 25% of patients would undergo surgery with curative resection at the time of initial diagnosis. There is no an effective screening test for early diagnosis. A characteristic that defines the pancreatic adenocarcinoma is its aggressiveness. There is a high prevalence of patients who present metastatic disease at the time of diagnosis, therefore, it is evident that this tumor is capable of early systemic spread. Starting from the high prevalence of patients who experience metastatic disease shortly after undergoing a potentially curative resection, it is likely that at the time of diagnosis, the majority of pancreatic adenocarcinomas have progressed to systemic spread. The overall 5-year survival of the patients is 5.8% and has not increased in the last 10 years; the 5-year survival rate after curative surgery is not higher (7%). Patients with resectable adenocarcinoma of the pancreas, only 15% are diagnosed at an early stage (T1, T2 without lymph node involvement), these are associated with improved survival. The surgery required to treat pancreatic cancer is aggressive. To optimize results, you need to follow a series of guidelines strictly. The current standard treatment regimen for resectable pancreatic adenocarcinoma is based on surgery plus adjuvant chemotherapy. With all this, the survival rate at five years after surgery is not greater than 7%, and in addition, there is a high percentage of patients who experience metastatic disease after surgical resection with curative intent. This indicates that at the time of diagnosis, it is likely that most adenocarcinomas pancreatic diseases have progressed to systemic spread. For this reason, for years there is a growing interest in investigating new therapeutic approaches, such as the role of neoadjuvant therapy.
Detailed description
Disease: Pancreatic cancer resectable plus risk factors
Hypothesis: The overall survival in patients treated with neoadjuvant chemotherapy before surgery -resection- plus adjuvant chemotherapy is higher than in patients treated per standard of care (only with adjuvant chemotherapy after surgery)
Objectives:
Main objective: To assess overall survival in patients treated with neoadjuvant chemotherapy before surgery-resection and adjuvant chemotherapy vs patients treated only with adjuvant chemotherapy after surgery-
Secondary objectives: To assess in both patients (experimental vs control arms): - Progression free survival - Number of completed cycles fo chemotherapy - Local and metastatic recurrence - Post-surgical morbidity - Resection rate R0 - Safety of the neoadjuvant chemotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Intervention: No intervention - standard of care | No intervention | –A group of patients with pancreatic carcinoma plus risk factors will be treated per standard of care on site (surgical resection and adjuvant therapy) |
| Experimental: Neoadyuvant therapy plus standard of care | Experimental | Drug: Folfirinox and Stereotactic Body RadiotherapyA group of patients with pancreatic carcinoma plus risk factors will be treated with neoadjuvant therapy before surgical resection and adjuvant therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. Patients diagnosed with resectable pancreatic adenocarcinoma plus risk factors
- 2. Histological diagnosis of pancreatic adenocarcinoma by fine needle aspiration (FNA) performed by Echoendoscopy.
- 3. Patients who have not received prior therapy for pancreatic cancer.
- 4. Biliary drainage prior to neoadjuvant treatment.
- 5. Age> 18 years and <70 years.
Key exclusion criteria (13 listed)
- 1. Patients with resectable pancreatic adenocarcinoma without risk factors.
- 2. Patients with borderline pancreatic adenocarcinoma.
- 3. Patients with locally advanced pancreatic adenocarcinoma.
- 4. Patients with metastatic adenocarcinoma of the pancreas.
- 5. Patients who have received prior chemotherapy or radiotherapy for pancreatic adenocarcinoma
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 |
|---|---|---|
| Folfirinox and Stereotactic Body RadiotherapyNeoadjuvant treatment is composed of folfirinox plus stereotactic body radiotherapy | Drug | Experimental: Neoadyuvant therapy plus standard of care |
Primary outcome
Overall Survival
Time frame: through study completion, an average of 3 year
Weeks until death
6 secondary outcomes
Period until recurrence disease
Time frame: through study completion, an average of 3 year
Number of completed chemotherapy cycles
Time frame: during chemiotherapy completion, an average of 3 year
Progression disease
Time frame: through study completion, an average of 3 year
Post-surgical events (if any)
Time frame: through post-surgical period (6 months)
Post-surgical events (if any)
Time frame: through post-surgical period (6 months)
Adverse events
Time frame: through study completion, including follow up period, an average of 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Individual participant dataSharing planned: Yes. The study results will be published in scientific oncologyc journal and available in PubMed and clinicaltrials websites
Related trials for Pancreatic Adenocarcinoma
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Pancreatic Cancer, Pancreatic Cancer Metastatic
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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.
María Jesús Castro Santiago study director
Hospital Universitario Puerta del Mar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Folfirinox and Stereotactic Body Radiotherapy in people with Pancreatic Adenocarcinoma and Pancreatic Cancer Resectable, run by Instituto de investigación e innovación biomédica de Cádiz at 1 site in Spain.
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 9 inclusion and 13 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 9 Aug 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 Spain. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Laura Quintana Lopez (639390856, laura.quintana@inibica.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: through study completion, an average of 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2022.