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

NCT05181605 | Unknown Phase 2

• 1 other identifier: ICI20-00047
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pancreatic Adenocarcinoma; Pancreatic Cancer Resectable

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Weeks until death

  through study completion, an average of 3 year

Secondary Outcomes (6)

• Period until recurrence disease

  through study completion, an average of 3 year

• Number of completed chemotherapy cycles

  during chemiotherapy completion, an average of 3 year

• Progression disease

  through study completion, an average of 3 year

• Post-surgical events (if any)

  through post-surgical period (6 months)

• Post-surgical events (if any)

  through post-surgical period (6 months)

Study Arms (2)

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

Drug: Folfirinox and Stereotactic Body Radiotherapy

Interventions

Folfirinox and Stereotactic Body Radiotherapy DRUG

Neoadjuvant treatment is composed of folfirinox plus stereotactic body radiotherapy

Experimental: Neoadyuvant therapy plus standard of care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients diagnosed with resectable pancreatic adenocarcinoma plus risk factors
• \. Histological diagnosis of pancreatic adenocarcinoma by fine needle aspiration (FNA) performed by Echoendoscopy.
• \. Patients who have not received prior therapy for pancreatic cancer.
• \. Biliary drainage prior to neoadjuvant treatment.
• \. Age\> 18 years and \<70 years.
• \. No history of cerebrovascular accident (CVA) or myocardial infarction (MI) in 6 months prior to neoadjuvant treatment.
• \. 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.
• \. Patients should have normal organs and spinal function.
• \. Ability to understand, and willingness to sign a written informed consent document

You may not qualify if:

• \. Patients with resectable pancreatic adenocarcinoma without risk factors.
• \. Patients with borderline pancreatic adenocarcinoma.
• \. Patients with locally advanced pancreatic adenocarcinoma.
• \. Patients with metastatic adenocarcinoma of the pancreas.
• \. Patients who have received prior chemotherapy or radiotherapy for pancreatic adenocarcinoma
• \. Pathological subtypes other than adenocarcinoma.
• \. A past history of allergic reaction attributed to 5-FU, leucovorin, Irinotecan or Oxaliplatin or to compounds of similar chemical or biological composition.
• \. Uncontrolled breakthrough disease.
• \. Patients with HIV, HBV and HCV positive and currently under antiretroviral therapy.
• \. Other active malignancies
• \. Pre-existing neuropathy, grade \> 1.
• \. Inflammatory bowel disease that is not controlled, or under current active therapy.

Sponsors & Collaborators

• Instituto de investigación e innovación biomédica de Cádiz: lead

Study Sites (1)

Hospital Puerta del Mar

Cadiz, 11010, Spain

RECRUITING

MeSH Terms

Interventions

folfirinox; Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• María Jesús Castro Santiago

  Hospital Universitario Puerta del Mar

  STUDY DIRECTOR

Central Study Contacts

Laura Quintana Lopez

CONTACT

639390856; laura.quintana@inibica.es

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: January 6, 2022
• Study Start: April 15, 2022
• Primary Completion: April 15, 2023
• Study Completion: December 1, 2024
• Last Updated: August 9, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: We hope data are available in Dec-2025 (anticipated).

Locations

ES (1)