Neoadjuvant vs Upfront Surgery for Resectable Pancreatic Cancer and Periampullary Cancer

Recruiting Phase 3 Interventional Study
Pancreas Cancer Periampullary Cancer Periampullary Carcinoma Resectable Pancreatic Cancer Resectable Ampullary Cancer Pancreas Adenocarcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
262 (estimated)
Sponsor
Minia University · Other
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About This Trial
Adjuvant chemotherapy after surgery significantly improved the survival of pancreatic cancer (PC) patients, but there is a problem that only about 50% of patients start adjuvant chemotherapy after pancreatectomy. Neoadjuvant chemotherapy might control potential metastatic lesions which are not being detected in early disease status and improve the R0 resection rate. In addition, it prevents futile…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Histologically or cytologically confirmed pancreatic head cancer or periampullary carcinoma(endoscopic ultrasound (EUS)-guided biopsy). * Clearly resectable disease as defined by National Comprehensive Cancer Network (NCCN) criteria on cross-sectional imaging: No involvement …
Contacts

Saleh K Saleh, MD

+201201765401

salehkhairy@mu.edu.eg

CONTACT

Rabeh K Saleh, MD

+201220065443

Rabeh.Saleh@mu.edu.eg

CONTACT