PROACTIVE: Surgical Resection Outcomes in Locally Advanced and Unresectable Pancreatic Cancer After Neoadjuvant Chemotherapy

NCT06132087 | Active Not Recruiting DMC

• 3 other identifiers: 3P-23-5NCI-2023-09210P30CA014089
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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 or lymph nodes (locally advanced) and that cannot be removed by surgery (unresectable). In general, surgery is considered the most effective treatment for pancreatic cancer, especially when the cancer is localized and has not spread to other organs. However, most patients with pancreatic cancer are not candidates for surgical removal because the cancer has grown into or close to nearby arteries, veins, or organs and there is a concern of damaging these nearby structures. Researchers want to find out if surgery after neoadjuvant chemotherapy can be done safely to completely remove the tumor in patients with locally advanced and unresectable pancreatic cancer.

Conditions

Locally Advanced Pancreatic Adenocarcinoma; Stage III Pancreatic Cancer American Joint Committee on Cancer v8; Unresectable Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• R0 resection rate

  Will be defined as the proportion of patients with negative resection margins after undergoing surgery.

  At time of surgery

Secondary Outcomes (4)

• Overall survival

  Up to 2 years

• Disease-free survival

  Up to 2 years

• Time to locoregional recurrence

  Up to 2 years

• Time to distant metastases

  Up to 2 years

Study Arms (1)

Treatment (surgical resection)

EXPERIMENTAL

Patients undergo laparoscopy followed by surgical resection with pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy at the discretion of the surgeon within 2-8 weeks following completion of standard of care neoadjuvant chemotherapy regimen. Patients undergo CT and blood sample collection throughout the study and/or MRI during screening. Patients also undergo tissue collection at time of surgical resection on study.

Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Distal Pancreatectomy; Procedure: Laparoscopy; Procedure: Magnetic Resonance Imaging; Procedure: Pancreaticoduodenectomy; Other: Questionnaire Administration; Procedure: Surgical Procedure; Procedure: Total Pancreatectomy

Interventions

Biospecimen Collection PROCEDURE

Undergo blood and tissue sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (surgical resection)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT Scan, Computed Axial Tomography (CAT), Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography

Treatment (surgical resection)

Distal Pancreatectomy PROCEDURE

Undergo distal pancreatectomy

Treatment (surgical resection)

Laparoscopy PROCEDURE

Undergo laparoscopy

Also known as: Peritoneoscopy, Keyhole surgery

Treatment (surgical resection)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, Nuclear Magnetic Resonance Imaging (NMRI), Nuclear Magnetic Resonance

Treatment (surgical resection)

Pancreaticoduodenectomy PROCEDURE

Undergo pancreaticoduodenectomy

Also known as: Pancreatoduodenectomy

Treatment (surgical resection)

Questionnaire Administration OTHER

Ancillary studies

Treatment (surgical resection)

Surgical Procedure PROCEDURE

Undergo surgical resection

Also known as: Operation, Surgery, Surgery Type, Surgery, Not Otherwise Specified, Surgical, Surgical Intervention, Surgical Interventions, Surgical Procedures, Type of Surgery

Treatment (surgical resection)

Total Pancreatectomy PROCEDURE

Undergo total pancreatectomy

Also known as: Total Excision of the Pancreas

Treatment (surgical resection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Interventions

Specimen Handling; Laparoscopy; Magnetic Resonance Spectroscopy; Pancreaticoduodenectomy; Surgical Procedures, Operative

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Spectrum Analysis; Chemistry Techniques, Analytical; Digestive System Surgical Procedures

Study Officials

• Steven R Grossman, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 15, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

US (1)