Trial Title:
PROACTIVE: Surgical Resection Outcomes in Locally Advanced and Unresectable Pancreatic Cancer After Neoadjuvant Chemotherapy
NCT ID:
NCT06132087
Condition:
Locally Advanced Pancreatic Adenocarcinoma
Stage III Pancreatic Cancer American Joint Committee on Cancer v8
Unresectable Pancreatic Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Pancreatic Neoplasms
Pancrelipase
Study type:
Interventional
Study phase:
N/A
Overall status:
Suspended
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood and tissue sample collection
Arm group label:
Treatment (surgical resection)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT
Arm group label:
Treatment (surgical resection)
Other name:
CAT Scan
Other name:
Computed Axial Tomography (CAT)
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Procedure
Intervention name:
Distal Pancreatectomy
Description:
Undergo distal pancreatectomy
Arm group label:
Treatment (surgical resection)
Intervention type:
Procedure
Intervention name:
Laparoscopy
Description:
Undergo laparoscopy
Arm group label:
Treatment (surgical resection)
Other name:
Peritoneoscopy
Other name:
Keyhole surgery
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Treatment (surgical resection)
Other name:
Magnetic Resonance
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
Nuclear Magnetic Resonance Imaging (NMRI)
Other name:
Nuclear Magnetic Resonance
Intervention type:
Procedure
Intervention name:
Pancreaticoduodenectomy
Description:
Undergo pancreaticoduodenectomy
Arm group label:
Treatment (surgical resection)
Other name:
Pancreatoduodenectomy
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Treatment (surgical resection)
Intervention type:
Procedure
Intervention name:
Surgical Procedure
Description:
Undergo surgical resection
Arm group label:
Treatment (surgical resection)
Other name:
Operation
Other name:
Surgery
Other name:
Surgery Type
Other name:
Surgery, Not Otherwise Specified
Other name:
Surgical
Other name:
Surgical Intervention
Other name:
Surgical Interventions
Other name:
Surgical Procedures
Other name:
Type of Surgery
Intervention type:
Procedure
Intervention name:
Total Pancreatectomy
Description:
Undergo total pancreatectomy
Arm group label:
Treatment (surgical resection)
Other name:
Total Excision of the Pancreas
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.
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 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
USC / Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Start date:
December 1, 2023
Completion date:
December 1, 2028
Lead sponsor:
Agency:
University of Southern California
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of Southern California
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06132087
