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Testing the Use of the Usual ...

Testing the Use of the Usual Chemotherapy Before and After Surgery for Removable Pancreatic Cancer

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

352 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-13

Study Completion Date

2030-11-01

Brief Summary

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This phase III trial compares perioperative chemotherapy (given before and after surgery) versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer that can be removed by surgery (removable/resectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before and after surgery (perioperatively) may work better in treating patients with pancreatic cancer compared to giving chemotherapy after surgery (adjuvantly).

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Detailed Description

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PRIMARY OBJECTIVES:

I. To evaluate and compare overall survival (OS) in patients with resectable pancreatic adenocarcinoma treated with perioperative fluorouracil, irinotecan hydrochloride, leucovorin calcium and oxaliplatin (modified \[m\]FOLFIRINOX) and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX.

SECONDARY OBJECTIVES:

I. To evaluate and compare disease-free survival (DFS) in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX.

II. To evaluate and compare time to locoregional recurrence (TLR) in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX.

III. To evaluate and compare time to distant metastases (TDM) in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX.

IV. To evaluate and compare the R0 resection rate in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX.

V. To evaluate and compare rate of unresectability in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX.

VI. To evaluate rate of pathologic complete response in patients randomized to the perioperative therapy arm.

VII. To evaluate and compare mFOLFIRINOX dose intensity delivered and number of cycles received in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX.

VIII. To evaluate and compare adverse event profile in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX.

IX. To compare physical functioning, nausea/vomiting, and diarrhea, as measured with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) between patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX.

X. To prospectively assess the influence of diet, body mass index, weight loss, physical activity, and other lifestyle habits on the disease-free survival and overall survival among patients with localized pancreatic cancers.

XI. To assess the influence of diet, obesity, physical activity, and other lifestyle habits on the risk of toxicity associated with chemotherapy.

XII. To evaluate the ability of computed tomography (CT)-based radiomics in distinguishing post-neoadjuvant chemotherapy (NAC) fibrosis from viable tumor in patients randomized to the perioperative therapy arm.

XIII. To determine whether CT-based radiomics retrieved from baseline examination may act as non-invasive predictors of survival outcome in patients randomized to the adjuvant therapy arm.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive oxaliplatin intravenously (IV) over 2 hours, irinotecan hydrochloride IV over 90 minutes, and leucovorin calcium over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-3. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Within 2-8 weeks of completing neoadjuvant chemotherapy, patients undergo surgical resection. Patients then receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and leucovorin calcium over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-3. Treatment repeats every 14 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo surgical resection. Beginning 3-12 weeks after surgery, patients then receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and leucovorin calcium over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-3. Treatment repeats every 14 days for 12 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 6 years.

Conditions

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Pancreatic Adenosquamous Carcinoma Resectable Pancreatic Adenocarcinoma Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

PRE-REGISTRATION:

* Pathology: Histologic or cytologic proof of pancreatic adenocarcinoma or adenosquamous carcinoma
* TNM Stage: Tx-4, N0-1, M0 (M0 disease does not include spread to distant lymph nodes and organs)
* Resectable Primary Tumor: Local radiographic reading must be consistent with resectable disease defined as the following on 1) arterial and venous phase contrast-enhanced abdominal/pelvic CT scan or abdominal/pelvic magnetic resonance imaging (MRI) scan and 2) chest CT:

* No involvement or abutment of the celiac artery, common hepatic artery, superior mesenteric artery, or replaced right hepatic artery (if applicable)
* Less than 180 degree interface between tumor and vessel wall of the portal vein or superior mesenteric vein, and patent portal vein/splenic vein confluence
* No evidence of metastatic disease
* Measurable disease or non-measurable disease o Non-measurable disease is defined as cytologic or histologic confirmation of adenocarcinoma of adenosquamous carcinoma by fine needle aspiration or core-biopsy of the pancreas without measurable disease by radiographic imaging

REGISTRATION:

* Confirmation of resectable disease by real-time central imaging review by the Alliance Imaging Core Lab at Imaging and Radiation Oncology Core (IROC) Ohio
* Determined to be appropriate candidate for curative-intent pancreatectomy by surgeon intending to perform the resection
* No prior radiation therapy, chemotherapy, targeted therapy, investigational therapy, or surgery for pancreatic cancer
* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects.
* Therefore, for women of childbearing potential only, a negative pregnancy test done =\< 14 days prior to registration is required
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Total Neuropathy Score \< 2
* Absolute neutrophil count (ANC) \>= 1,500/uL
* Platelet count \>= 100,000/uL
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) (If obstructive jaundice is present, then biliary drainage must be initiated and total bilirubin =\< 3.0)
* Creatinine =\< 1.5 x ULN OR calculated (Calc.) creatinine clearance \>= 30 mL/min (Calculated using the Cockcroft-Gault equation)
* No known Gilbert's Syndrome or known homozygosity for UGAT1A1\*28 polymorphism
* No comorbid conditions that would prohibit curative-intent pancreatectomy
* Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug prior to registration
* Chronic concomitant treatment with strong inducers of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inducers must discontinue the drug prior to registration

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cristina R. Ferrone, MD

Role: STUDY_CHAIR

Massachusetts General Hospital

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Cristina R. Ferrone, MD

Role: CONTACT

[email protected]

617-643-6189

Facility Contacts

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Site Public Contact

Role: primary

251-435-4584

Role: primary

877-642-4691

Site Public Contact

Role: primary

[email protected]

877-642-4691

Role: primary

323-865-0451

Site Public Contact

Role: primary

[email protected]

800-398-3996

203-739-8074

Site Public Contact

Role: primary

[email protected]

203-852-2996

Site Public Contact

Role: primary

202-444-2223

Role: primary

312-864-5204

Role: primary

708-226-4357

Site Public Contact

Role: primary

[email protected]

Role: primary

217-545-7929

Role: primary

515-241-3305

Site Public Contact

Role: primary

515-241-6727

Site Public Contact

Role: primary

515-241-3305

Site Public Contact

Role: primary

[email protected]

515-358-6613

Role: primary

443-849-3706

Site Public Contact

Role: primary

[email protected]

617-636-5000

Site Public Contact

Role: primary

877-726-5130

Role: primary

248-551-7695

Site Public Contact

Role: primary

[email protected]

734-712-7251

Site Public Contact

Role: primary

[email protected]

248-849-5332

Role: primary

314-996-5569

Role: primary

212-639-7592

Site Public Contact

Role: primary

856-325-6757

Role: primary

212-639-7592

Site Public Contact

Role: primary

212-639-7592

Role: primary

201-833-6312

Site Public Contact

Site Public Contact

Role: primary

[email protected]

252-634-6589

[email protected]

503-215-2614

540-981-7377

Site Public Contact

Role: primary

[email protected]

Site Public Contact

Role: primary

[email protected]

425-261-3529

Site Public Contact

Role: primary

800-804-8824

Site Public Contact

Role: primary

800-804-8824

Role: primary

[email protected]

Role: primary

416-480-5000

Site Public Contact

Role: primary

[email protected]

514-934-1934 ext. 48354

Site Public Contact

Role: primary

[email protected]

Site Public Contact

Role: primary

[email protected]

819-820-6480

Other Identifiers

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NCI-2020-01560

Identifier Type: REGISTRY

Identifier Source: secondary_id

U10CA180821

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A021806

Identifier Type: -

Identifier Source: org_study_id

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Testing the Use of the Usual Chemotherapy Before and After Surgery for Removable Pancreatic Cancer

Study Results

Basic Information

Brief Summary

Related Clinical Trials

Chemotherapy and Radiation Therapy Before Surgery Followed by Gemcitabine in Treating Patients with Pancreatic Cancer

Combination Chemotherapy and Radiation Therapy Plus Surgery in Treating Patients With Advanced Cancer of the Pancreas

Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer

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Chemotherapy and Surgical Resection in Patients With Hepatic Oligometastatic Adenocarcinoma of the Pancreas

Detailed Description

Conditions

Study Design

Study Groups

Arm I (perioperative chemotherapy, surgery)

Oxaliplatin

Irinotecan Hydrochloride

Leucovorin Calcium

Fluorouracil

Resection

Questionnaire Administration

Arm II (surgery, adjuvant chemotherapy)

Oxaliplatin

Irinotecan Hydrochloride

Leucovorin Calcium

Fluorouracil

Resection

Questionnaire Administration

Interventions

Oxaliplatin

Irinotecan Hydrochloride

Leucovorin Calcium

Fluorouracil

Resection

Questionnaire Administration

Eligibility Criteria

Inclusion Criteria

Sponsors

National Cancer Institute (NCI)

Alliance for Clinical Trials in Oncology

Responsible Party

Principal Investigators

Cristina R. Ferrone, MD

Locations

University of Alabama at Birmingham Cancer Center

Thomas Hospital

Mobile Infirmary Medical Center

University of South Alabama Mitchell Cancer Institute

Anchorage Associates in Radiation Medicine

Alaska Breast Care and Surgery LLC

Alaska Oncology and Hematology LLC

Alaska Women's Cancer Care

Anchorage Oncology Centre

Katmai Oncology Group

Providence Alaska Medical Center

Banner University Medical Center - Tucson

University of Arizona Cancer Center-North Campus

Mercy Hospital Fort Smith

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

University of Arkansas for Medical Sciences

Kaiser Permanente-Anaheim

Kaiser Permanente-Deer Valley Medical Center

Sutter Cancer Centers Radiation Oncology Services-Auburn

Kaiser Permanente-Bellflower

Alta Bates Summit Medical Center-Herrick Campus

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Mills-Peninsula Medical Center

Sutter Cancer Centers Radiation Oncology Services-Cameron Park

Community Cancer Institute

UC Irvine Health Cancer Center-Newport

Kaiser Permanente Dublin

Kaiser Permanente-Fremont

Kaiser Permanente Fresno Orchard Plaza

Kaiser Permanente-Fresno

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Kaiser Permanente-Irvine

UC San Diego Moores Cancer Center

Kaiser Permanente Los Angeles Medical Center

Los Angeles General Medical Center

USC / Norris Comprehensive Cancer Center