Status:
ACTIVE_NOT_RECRUITING
PROACTIVE: Surgical Resection Outcomes in Locally Advanced and Unresectable Pancreatic Cancer After Neoadjuvant Chemotherapy
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Locally Advanced Pancreatic Adenocarcinoma
Stage III Pancreatic Cancer American Joint Committee on Cancer v8
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This clinical trial tests how well surgical resection after chemotherapy given before surgery to make the tumor smaller (neoadjuvant) works to treat pancreatic cancer that has spread to nearby tissue ...
Detailed Description
PRIMARY OBJECTIVE: I. Evaluate the R0 resection in patients with locally advanced pancreatic adenocarcinoma treated with perioperative chemotherapy and surgery. SECONDARY OBJECTIVES: I. To evaluate...
Eligibility Criteria
Inclusion
- Histologic or cytologic proof of pancreatic adenocarcinoma
- Locally advanced, stage III (T4NxM0) and unresectable by National Comprehensive Cancer Network (NCCN) Guidelines prior to perioperative chemotherapy
- Patients must have measurable disease at diagnosis per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
- At least 4 cycles of perioperative chemotherapy (gemcitabine \[Gem\]/nab-paclitaxel or fluorouracil, irinotecan, leucovorin and oxaliplatin \[FOLFIRINOX\]) received with no evidence of progression on restaging scans per RECIST 1.1
- Age ≥ 18 years
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-1
- Absolute neutrophil count ≥ 1,500/mcL
- Platelets ≥ 100,000/mcl
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) if no biliary stenting has been done or 2.0 x ULN if patient is status post (s/p) biliary stenting or two down trending values
- Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamic-pyruvic transaminase \[SPGT\]) ≤ 2.5 X ULN
- Creatinine (Cr) ≤ 1.5 mg/dL or Cr clearance ≥ 30 mL/min (as estimated by Cockcroft Gault)
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: Has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
- Ability to understand and the willingness to sign a written informed consent
Exclusion
- Patient with known distant metastases
- Patients who have not recovered from adverse events of chemotherapy due to agents administered more than 4 weeks earlier
- Patients who have progressed on 2 prior systemic chemotherapy lines or received prior radiotherapy for pancreatic cancer
- Patients may not be receiving any other investigational agents
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT06132087
Start Date
December 1 2023
End Date
December 1 2028
Last Update
November 25 2025
Active Locations (1)
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1
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033