Pancreatic cancer
Conditions
Interventions
RAMPS group:Radical anterograde total resection of pancreatic body and tail cancer
SRPS group:Standard pancreatic body and tail cancer radical resection
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
19 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Treatment-naive PDAC with histological or cytological diagnosis. 2. Adenocarcinoma of the pancreatic body and tail duct, together with an absence of distant metastases (e.g., liver, peritoneum, lung) and periadrenal infiltration as shown by radiological assessment (enhanced computed tomography [CT], enhanced magnetic resonance imaging [MRI], or positron emission tomography-computed tomography [PET-CT]) and surgery. 3. The presence of a standard resectable ductal adenocarcinoma in the body and tail of the pancreas, evaluated both preoperatively and intraoperatively (refer to NCCN guideline 202 of Pancreatic Cancer and ISGPS consensus 2014 of standard distal pancreatectomy). 4. No indications for neoadjuvant therapy (chemotherapy or radiation). 5. No previous systemic therapy for advanced disease. 6. No contra-indications for curative surgery. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 8. Aged between 19 and 80 years. 9. Laboratory findings four weeks before randomization: Adequate bone marrow function (Hb >= 6.0 mmol/L, absolute neutrophil count >= 1.5 x 10^9/L, platelet count >= 100 x 10^9/L), renal function (serum creatinine = 30ml/min), liver function (serum bilirubin <= 2 x ULN, serum transaminases <= 3 x ULN). 10. Expectation of adequate follow-up. 11. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnancy, lactation. 2. Primary tumor deemed unresectable due to e.g., neurovascular encasement, significant ingrowth in the pancreatic head. 3. Conditions precluding safe or feasible resection of the primary tumor e.g., massive ascites. 4. Intraoperative exclusion criteria including evidence of metastasis, non-pancreatic primary disease, unresectable tumor, Gerota fascia invasion. 5. Postoperative exclusion criterion of lack of pathological confirmation of pancreatic ductal adenocarcinoma. 6. History of a different primary tumor five years before randomization, excluding basal cell carcinoma of the skin or an adequately treated in situ carcinoma in any organ. 7. Any medical condition precluding the safe administration of systemic treatment. 8. The presence of cardiopulmonary dysfunction affecting tolerance of surgery. 9. Requirements for neoadjuvant therapy (chemotherapy or radiation).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence Free Survival;R0 resection rate;number of dissected lymph nodes;post-operative complications;quality of life (QoL) scores; | — |
Countries
China
Contacts
Public ContactWang Wei
Fudan University Shanghai Cancer Center
Outcome results
None listed