Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05181605
Study type Interventional
Source Instituto de investigación e innovación biomédica de Cádiz
Contact Laura Quintana Lopez
Phone 639390856
Email laura.quintana@inibica.es
Status Recruiting
Phase Phase 2/Phase 3
Start date April 15, 2022
Completion date December 1, 2024

See also
  Status Clinical Trial Phase
Completed NCT05305001 - Germline Mutations Associated With Hereditary Pancreatic Cancer in Unselected Patients With Pancreatic Cancer in Mexico
Recruiting NCT05059444 - ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Completed NCT01959672 - Chemotherapy, Stereotactic Body Radiation Therapy & Nelfinavir Mesylate in Locally Advanced Pancreatic Cancer Phase 2
Recruiting NCT03673423 - Evaluation of the Interobserver Agreement on the Resectability Status of Patients With a Pancreatic Cancer
Terminated NCT02495896 - Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors Phase 1
Recruiting NCT05351983 - Patient-derived Organoids Drug Screen in Pancreatic Cancer N/A
Not yet recruiting NCT06026943 - Alpha Radiation Emitters Device for the Treatment of Pancreatic Cancer Emitters for the Treatment of Locally Advanced Pancreatic Cancer N/A
Completed NCT03054987 - Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography for Malignant Distal Biliary Obstruction N/A
Terminated NCT02345460 - Preoperative Folfirinox for Resectable Pancreatic Adenocarcinoma - A Phase II Study Phase 2
Recruiting NCT02072616 - Detection of Circulating Tumor Cells for the Diagnostic of Pancreatic Adenocarcinoma. Phase 3
Completed NCT02174887 - Biological Effect of Nab-paclitaxel Combined to Gemcitabine in Metastatic Pancreatic Cancer Phase 1
Recruiting NCT03703063 - Alternative Neoadjuvant Chemotherapy in Resectable and Borderline Resectable Pancreatic Cancer Phase 1
Terminated NCT04077372 - Assessment of a Serious Illness Conversation Guide (SICG) in Advanced Gastro-Intestinal Cancers N/A
Recruiting NCT03073785 - Hypofractionated Stereotactic Body Radiation & Fluorouracil or Capecitabine for Locally Advanced Pancreatic Cancer Phase 2
Completed NCT03665441 - Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment in PAC Phase 3
Recruiting NCT04627246 - Personalized Vaccine With SOC Chemo Followed by Nivo in Pancreatic Cancer Phase 1
Not yet recruiting NCT06217666 - Study Examining the Safety and Toxicity of Stereotactic Body Radiotherapy (SBRT) Followed by PCX12 Immunotherapy Delivered by Intratumoral Injection for the Treatment of Patients With Locally Advanced Pancreatic Adenocarcinoma (LAPC) Phase 1
Recruiting NCT05585320 - A Phase 1/2a Study of IMM-1-104 in Participants With Previously Treated, RAS-Mutant, Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Completed NCT04119362 - PARAGON Platform for Outcome, Quality of Life, and Translational Research on Pancreatic Cancer
Completed NCT03105921 - Irreversible Electroporation (NanoKnife) for the Treatment of Pancreatic Adenocarcinoma N/A