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โ† Trials
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Neoadjuvant vs Upfront Surgery for Resectable Pancreatic Cancer and Periampullary Cancer

RecruitingPhase 3Ages 18 Years - 75 YearsAllMinia University
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In plain words

What the trial is, and whether it could suit you

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 pro

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 or abutment of the celiac artery, common hepatic artery, superior mesenteric artery, or replaced right hepatic artery . Less than 180 degree interface between tumor and vessel wall of the portal vein or superior mesenteric vein, and patent portal vein/splenic vein confluence No evidence of metastatic disease. * Eastern Cooperative Oncology Group (ECOG)=0-1 \& American Society of Anesthesiologists (ASA) score \<4. * Written informed consent. * Medical history without previous pancreatic resection or pancreatic cancer. * Adequate organ function (liver, kidney, bone marrow) (serum creatinine โ‰ค2.0 mg/dL,reference range 0.5-1.20 mg/dL; serum albumin โ‰ฅ2.5 g/dL, reference range 3.5-5.3; aspartate aminotransferase (AST) โ‰ค95 U/L, reference range 0-38; Alanine aminotransferase (ALT) โ‰ค102 U/L, reference range 0-41; prothrombin time โ‰ค1.8, reference range 0-1.20; partial thromboplastin time โ‰ค1.8, reference range 0.82-1.25; leukocyte count greater than 3.5ร—109/L, reference range 4.2-9.0; platelet count greater than 100ร—109/L, reference range 130-400; hemoglobin โ‰ฅ9 g/dL, reference range 12-16). Exclusion Criteria: * Borderline resectable or locally advanced pancreatic or periampullary cancer. * Tumor at the body or tail of the pancreas. * Distant metastases. * Prior chemotherapy , surgery or radiotherapy for pancreatic cancer. * Severe comorbidities precluding surgery or chemotherapy. * Pregnancy or lactation. * Other neoplastic diseases (malignant)diagnosed in the past 5 years. * Major surgery or traumatic event in the past 28 days.
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What it tests

  • Neoadjuvant chemotherapy
  • Upfront Surgery Group
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Where

1 site
Liver and GIT hospital , Minia University
Minya, Egypt
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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