The Complexity of Neoadjuvant Therapy for Operable Pancreatic Cancer: Lessons Learned From SWOG S1505.
Douglas B Evans
https://pubmed.ncbi.nlm.nih.gov/32657915Actively Recruiting
Phase 3
Age: 18Years - 75Years
All Genders
ID07081360
Neoadjuvant Chemotherapy Followed by Surgery Versus Upfront Surgery for Clearly Resectable Pancreatic Head Cancer and Periampullary Cancer: A Randomized Controlled Trial
Led by Minia University · Updated on 2025-08-29
262
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare two treatment approaches for patients with clearly resectable pancreatic head cancer and periampullary cancer. It investigates whether receiving chemotherapy before surgery (neoadjuvant chemotherapy) improves overall survival compared to having surgery first followed by chemotherapy. The study addresses the challenge that only about half of patients start chemotherapy after surgery and explores whether pre-surgery treatment can better control hidden cancer spread and improve surgical outcomes. Participants will be randomly assigned to one of two groups: one group will receive neoadjuvant chemotherapy using the mFOLFIRINOX regimen followed by pancreaticoduodenectomy surgery, while the other group will undergo upfront laparoscopic pancreaticoduodenectomy followed by adjuvant chemotherapy. The trial includes monitoring of resection rates, chemotherapy completion, and surgical complications. Both treatment strategies are closely evaluated over several months. During the study, participants will be regularly assessed through imaging and laboratory tests to evaluate overall survival up to three years. Secondary measurements include disease-free survival, recurrence rates, response to chemotherapy, and surgical outcomes such as margin status. Researchers will also track perioperative complications and biomarker changes during chemotherapy. The study duration includes follow-up for up to three years to monitor long-term outcomes and treatment effects.
CONDITIONS
Brief Title
Neoadjuvant vs Upfront Surgery for Resectable Pancreatic Cancer and Periampullary Cancer
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed pancreatic head cancer or periampullary carcinoma by endoscopic ultrasound-guided biopsy.
- Clearly resectable disease as defined by National Comprehensive Cancer Network criteria on imaging with no major artery involvement and less than 180-degree interface with portal or superior mesenteric vein.
- No evidence of metastatic disease.
- Eastern Cooperative Oncology Group performance status 0-1 and American Society of Anesthesiologists score less than 4.
- Written informed consent.
- No previous pancreatic resection or pancreatic cancer history.
- Adequate organ function including liver, kidney, and bone marrow as defined by specific laboratory values.
You will not qualify if you...
- Borderline resectable or locally advanced pancreatic or periampullary cancer.
- Tumor located at the body or tail of the pancreas.
- Presence of distant metastases.
- Prior chemotherapy, surgery, or radiotherapy for pancreatic cancer.
- Severe comorbidities that prevent surgery or chemotherapy.
- Pregnancy or breastfeeding.
- Other malignant neoplastic diseases diagnosed within the past 5 years.
- Major surgery or traumatic event within the past 28 days.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Neoadjuvant Treatment
Duration - 12 to 16 weeks
Participants in the neoadjuvant chemotherapy group receive mFOLFIRINOX chemotherapy before surgery.
Multiple visits for chemotherapy administration over 12 to 16 weeks
Surgery
Duration - 1 day
Participants undergo pancreaticoduodenectomy surgery either after neoadjuvant chemotherapy or as upfront treatment.
1 surgery visit (in-person)
Adjuvant Chemotherapy
Duration - Up to 4 months
Participants who undergo upfront surgery receive adjuvant chemotherapy after surgery.
Multiple visits for chemotherapy administration up to 4 months
Post-operative Follow-up
Duration - Up to 90 days
Participants are monitored for complications and recovery for up to 90 days after surgery.
Approximately 6 post-operative visits
Long-term Monitoring
Duration - Up to 3 years
Participants are followed for overall survival, disease-free survival, and recurrence outcomes for up to 3 years after surgery.
Periodic visits over 3 years
Trial Site Locations
Total: 1 location
1
Liver and GIT hospital , Minia University
Minya, Minya Governorate, Egypt, 61519
Actively Recruiting
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Research Team
S
Saleh K Saleh, MD
R
Rabeh K Saleh, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Ali A Mokdad, Rebecca M Minter, Hong Zhu...
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Yoon Suk Lee, Jong-Chan Lee, Se Yeol Yang...
https://pubmed.ncbi.nlm.nih.gov/31666626Upfront Surgery versus Neoadjuvant Therapy for Resectable Pancreatic Cancer: Systematic Review and Bayesian Network Meta-analysis.
Alison Bradley, Robert Van Der Meer
https://pubmed.ncbi.nlm.nih.gov/30867522