Survival Analysis After Neoadjuvant Therapy In Patients With Resectable Pancreatic Cancer And Risk Factors

Study Overview

Survival Analysis After Neoadjuvant Therapy in Patients With Resectable Pancreatic Cancer and Risk Factors

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.

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

Pancreatic Adenocarcinoma
Pancreatic Cancer Resectable

DRUG: Folfirinox and Stereotactic Body Radiotherapy

ICI20-00047

Study Record Dates

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
First Submitted 2021-11-08	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-08-05
First Submitted that Met QC Criteria 2021-12-20	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-08-09
First Posted (ACTUAL) 2022-01-06	Results First Posted N/A	Last Verified 2021-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
NO_INTERVENTION: No Intervention: No intervention - standard of care 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: Experimental: Neoadyuvant therapy plus standard of care A group of patients with pancreatic carcinoma plus risk factors will be treated with neoadjuvant therapy before surgical resection and adjuvant therapy	DRUG: Folfirinox and Stereotactic Body Radiotherapy Neoadjuvant treatment is composed of folfirinox plus stereotactic body radiotherapy

Participant Group/Arm

Intervention/Treatment

NO_INTERVENTION: No Intervention: No intervention - standard of care

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: Experimental: Neoadyuvant therapy plus standard of care

A group of patients with pancreatic carcinoma plus risk factors will be treated with neoadjuvant therapy before surgical resection and adjuvant therapy

DRUG: Folfirinox and Stereotactic Body Radiotherapy

Neoadjuvant treatment is composed of folfirinox plus stereotactic body radiotherapy

Primary Outcome Measures	Measure Description	Time Frame
Overall Survival	Weeks until death	through study completion, an average of 3 year

Secondary Outcome Measures	Measure Description	Time Frame
Period until recurrence disease	Weeks until progression disease (local or metastatic recurrence)	through study completion, an average of 3 year
Number of completed chemotherapy cycles	Number of completed chemotherapy cycles	during chemiotherapy completion, an average of 3 year
Progression disease	Progression disease per RECIST 1.1	through study completion, an average of 3 year
Post-surgical events (if any)	physiological parameter for post-surgical events (if any)	through post-surgical period (6 months)
Post-surgical events (if any)	Number of post-surgical events (if any)	through post-surgical period (6 months)
Adverse events	Type and number of adverse events.	through study completion, including follow up period, an average of 4 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Laura Quintana Lopez

Phone Number: 639390856

Email: laura.quintana@inibica.es

Participation Criteria

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:

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.
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

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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: María Jesús Castro Santiago, Hospital Universitario Puerta del Mar

Publications

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

Learn

Resources

Patients

Caregivers

Clinical Trial Record