NCT05181605

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Instituto de investigación e innovación biomédica de Cádiz · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pancreatic Adenocarcinoma
• Pancreatic Cancer Resectable

Interventions

Type	Name	Description
DRUG	Folfirinox and Stereotactic Body Radiotherapy	Neoadjuvant treatment is composed of folfirinox plus stereotactic body radiotherapy

Timeline

• Start date: 2022-04-15
• Primary completion: 2023-04-15
• Completion: 2024-12-01
• First posted: 2022-01-06
• Last updated: 2022-08-09

Locations

1 site across 1 country: Spain