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Neoadjuvant vs Upfront Surgery for Resectable Pancreatic Cancer and Periampullary Cancer

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv5
  2. Primary completion date: Jul 20, 2026 to Jul 20, 2028v4 Show 4 more changesShow less
    • Study completion date: Aug 20, 2026 to Aug 20, 2028
    • Secondary endpoints revised (16)
    • Eligibility criteria expanded, about 2 words
    • Study description expanded, about 2 words
  3. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  4. Re-verified, no change to tracked fieldsv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 surgery by selecting patients with rapid progression of disease. Furthermore, compared to chemotherapy administered after surgery, more patients can complete the planned chemotherapy schedule in neoadjuvant setting. There are still few studies worldwide that prospectively explored the efficacy of neoadjuvant chemotherapy in resectable PC and periampullary cancer and the administration of neoadjuvant therapy in resectable PC depends on individual clinical judgment. Therefore, systematic and prospective clinical trials are essential to standardize treatment protocol in resectable PC and periampullary Cancer. This randomized controlled trial compares neoadjuvant chemotherapy followed by surgery versus upfront surgery for patients with clearly resectable pancreatic head cancer and periampullary cancer. The study aims to determine if neoadjuvant chemotherapy improves overall survival compared to immediate surgery followed by adjuvant chemotherapy.
Trial Details
NCT Number NCT07081360
Lead Sponsor Minia University
Conditions
(from sponsor)		 Pancreas Cancer, Periampullary Cancer, Periampullary Carcinoma Resectable, Pancreatic Cancer Resectable, Ampullary Cancer, Pancreas Adenocarcinoma
Related terms Pancreatic Neoplasms
Enrollment 262 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov