NCT05181605

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

Status unknown Phase 2, PHASE3 Last updated 9 August 2022

What this trial tests

Phase 2, PHASE3 trial testing Folfirinox and Stereotactic Body Radiotherapy in Pancreatic Adenocarcinoma in 116 participants. Status unknown.

Timeline

15 April 2022

Primary endpoint
15 April 2023

1 December 2024

Quick facts

Lead sponsor	Instituto de investigación e innovación biomédica de Cádiz
Phase	Phase 2, PHASE3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	116
Start date	15 April 2022
Primary completion	15 April 2023
Estimated completion	1 December 2024
Sites	1 location across Spain

Drugs / interventions tested

• Folfirinox and Stereotactic Body Radiotherapy — full drug profile →

Conditions studied

• Pancreatic Adenocarcinoma — all drugs for Pancreatic Adenocarcinoma →
• Pancreatic Cancer Resectable — all drugs for Pancreatic Cancer Resectable →

Sponsor

Instituto de investigación e innovación biomédica de Cádiz — full company profile →

Who can join

Adults 18 to 70, any sex, with Pancreatic Adenocarcinoma or Pancreatic Cancer Resectable. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Top advances of the year: Pancreatic cancer.
   Warren EAK, Lesinski GB, Maithel SK. · · 2023 · cited 5× · PMID 37776536 · DOI 10.1002/cncr.35031
2. Neoadjuvant therapy in resectable pancreatic cancer: A promising curative method to improve prognosis.
   Zhang HQ, Li J, Tan CL, Chen YH, et al · · 2022 · cited 4× · PMID 36310705 · DOI 10.4251/wjgo.v14.i10.1903
3. Role of radiotherapy in surgical approaches to pancreatic cancer treatment: A narrative review.
   Yasuda S, Nagai M, Nakamura K, Matsuo Y, et al · · 2025 · cited 2× · PMID 40385329 · DOI 10.1002/ags3.70012