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

Phase

N/A

Condition

Digestive System Neoplasms

Adenocarcinoma

Treatment

Computed Tomography

Laparoscopy

Pancreaticoduodenectomy

Clinical Study ID

NCT06132087

3P-23-5

NCI-2023-09210

3P-23-5

P30CA014089

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Histologic or cytologic proof of pancreatic adenocarcinoma
Locally advanced, stage III (T4NxM0) and unresectable by National ComprehensiveCancer Network (NCCN) Guidelines prior to perioperative chemotherapy
Patients must have measurable disease at diagnosis per Response Evaluation CriteriaIn Solid Tumors (RECIST) 1.1
At least 4 cycles of perioperative chemotherapy (gemcitabine [Gem]/nab-paclitaxel orfluorouracil, irinotecan, leucovorin and oxaliplatin [FOLFIRINOX]) received with noevidence 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 biliarystenting has been done or 2.0 x ULN if patient is status post (s/p) biliary stentingor 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 CockcroftGault)
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, forthe duration of study participation, and for 90 days following completion oftherapy. Should a woman become pregnant or suspect she is pregnant whileparticipating 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 thefollowing criteria: Has not undergone a hysterectomy or bilateral oophorectomy; orhas not been naturally postmenopausal for at least 12 consecutive months (i.e., hashad menses at any time in the preceding 12 consecutive months)
Ability to understand and the willingness to sign a written informed consent

Exclusion

Exclusion Criteria:

Patient with known distant metastases
Patients who have not recovered from adverse events of chemotherapy due to agentsadministered more than 4 weeks earlier
Patients who have progressed on 2 prior systemic chemotherapy lines or receivedprior radiotherapy for pancreatic cancer
Patients may not be receiving any other investigational agents
Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliancewith study requirements
Patients must not be pregnant or nursing due to the potential for congenitalabnormalities and the potential of this regimen to harm nursing infants

Study Design

Computed Tomography

December 01, 2023

December 01, 2028

Study 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 overall survival (OS) in patients with locally advanced pancreatic adenocarcinoma treated with perioperative chemotherapy and surgery.

II. To measure disease free survival (DFS) in patients with locally advanced pancreatic adenocarcinoma treated with perioperative chemotherapy and surgery.

III. To evaluate the correlation between post-neoadjuvant/preoperative radiological staging and pathologic staging.

IV. To estimate time to distant metastases (TDM) in patients in patients with locally advanced pancreatic adenocarcinoma treated with perioperative chemotherapy and surgery.

EXPLORATORY OBJECTIVES:

I. To evaluate the correlation between post-neoadjuvant/preoperative radiological staging and pathologic staging.

II. To evaluate objective response rate (ORR) in patients with locally advanced pancreatic adenocarcinoma treated with perioperative chemotherapy.

III. To assess if mutations on next-generation sequencing (NGS) testing and the change in circulating tumor deoxyribonucleic acid (ctDNA) pre- and post-operative is predictive of DFS or OS in patients with locally advanced pancreatic adenocarcinoma treated with perioperative chemotherapy and surgery.

IV. To evaluate the rate of unresectability in patients with locally advanced pancreatic adenocarcinoma treated with perioperative chemotherapy.

V. To evaluate pathologic tumor response and rate of pathologic complete response (pCR) in patients with locally advanced pancreatic adenocarcinoma treated with perioperative chemotherapy and surgery.

VI. To evaluate correlation between R0 resection rate and pathologic treatment response and survival outcomes.

VII. To evaluate number of cycles of perioperative chemotherapy received in patients with locally advanced pancreatic adenocarcinoma treated with perioperative chemotherapy and surgery.

VIII. To evaluate the adverse event profile in patients with locally advanced pancreatic adenocarcinoma treated with perioperative chemotherapy and surgery.

IX. To evaluate the physical functioning, nausea/vomiting, and diarrhea, as measured with the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30) in patients with locally advanced pancreatic adenocarcinoma treated with perioperative chemotherapy and surgery.

X. To evaluate the average operative time in minutes in patients with locally advanced pancreatic adenocarcinoma treated with perioperative chemotherapy and surgery.

XI. To evaluate the estimated blood loss (mL) in patients with locally advanced pancreatic adenocarcinoma treated with perioperative chemotherapy and surgery.

XII. To assess the length of hospital, stay in for patients with locally advanced pancreatic adenocarcinoma treated with perioperative chemotherapy and surgery.

XIII. To evaluate the incidence of thrombosis in patients with locally advanced pancreatic adenocarcinoma treated with perioperative chemotherapy and surgery.

OUTLINE:

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 computed tomography (CT) and blood sample collection throughout the study and/or magnetic resonance imaging (MRI) during screening. Patients also undergo tissue collection at time of surgical resection on study.

After completion of study intervention, patients are followed up at 30 days, every 3 months for the first year, then every 6 months until 2 years.

Connect with a study center

USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Site Not Available
USC / Norris Comprehensive Cancer Center
Los Angeles 5368361, California 5332921 90033
United States
Site Not Available

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