Clinical trial NCT05181605: Survival Analysis After Neoadjuvant Therapy in Patients With Resectable Pancreatic Cancer and Risk Factors
Official title: Survival Analysis After Neoadjuvant Therapy in Patients With Resectable Pancreatic Cancer and Risk Factors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Pancreatic Adenocarcinoma
Pancreatic Cancer Resectable
Lead sponsor: Instituto de investigación e innovación biomédica de Cádiz
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Overall Survival
timeFrame: through study completion, an average of 3 year
Secondary outcomes:
measure: Period until recurrence disease
timeFrame: through study completion, an average of 3 year
measure: Number of completed chemotherapy cycles
timeFrame: during chemiotherapy completion, an average of 3 year
measure: Progression disease
timeFrame: through study completion, an average of 3 year
measure: Post-surgical events (if any)
timeFrame: through post-surgical period (6 months)
measure: Post-surgical events (if any)
timeFrame: through post-surgical period (6 months)
measure: Adverse events
timeFrame: through study completion, including follow up period, an average of 4 years
Other outcomes:
Locations:
city: Cádiz
country: Spain
facility: Hospital Puerta del Mar
Study officials:
affiliation: Hospital Universitario Puerta del Mar
name: María Jesús Castro Santiago
role: STUDY_DIRECTOR
References: