Observation of Perioperative FOLFIRINOX for Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06122480
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 53
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

This is a Phase II, Open-Label, Single Arm trial investigating the outcomes of neoadjuvant FOLFIRINOX chemotherapy in patients with hepatic or pulmonary oligometastatic pancreatic adenocarcinoma.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Ductal Adenocarcinoma; Oligometastatic Disease	Drug: FOLFIRINOX chemotherapy	Phase 2

Detailed Description

This clinical trial aims to evaluate the effectiveness and safety of neoadjuvant FOLFIRINOX chemotherapy in patients with hepatic or pulmonary oligometastatic pancreatic adenocarcinoma. FOLFIRINOX is administered in 14-day cycles following a specific treatment protocol. The primary goal is to assess treatment effectiveness, with secondary objectives including evaluating safety, impact on patients' health-related quality of life (HR-QoL), and analyzing the tumor microenvironment in organ-specific metastases of pancreatic cancer. An exploratory objective involves analyzing overall survival while considering HR-QoL in patients enrolled in a separate Institutional Review Board protocol for quality of life assessment.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Perioperative Irinotecan Combined With Oxaliplatin and 5-Fluoracil/Folinic Acid (FOLFIRINOX) For Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma (PHOLIPANC): A Phase II, Open-Label, Single Arm Trial
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Dec 31, 2027
• Anticipated Study Completion Date: Apr 1, 2028

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Treatment arm Eligible patients will undergo neoadjuvant FOLFIRINOX chemotherapy with the following order and dosing schedule: Irinotecan hydrochloride trihydrate is administered intravenously over approximately 90 minutes at a dose of 180 mg/m^2. Oxaliplatin is given intravenously over 2 hours at a dosage of 85 mg/m^2. 5-Fluorouracil is administered intravenously over approximately 46 hours at a dosage of 2400 mg/m^2. This treatment regimen is a modified FOLFIRINOX protocol.

Drug: FOLFIRINOX chemotherapy; Perioperative Irinotecan Combined with Oxaliplatin and 5-Fluoracil/Folinic Acid (FOLFIRINOX)

Outcome Measures

Primary Outcome Measures

1. Overall survival after R0/R1 resection (OS-res) (only patients with R0/R1 resection) [48 months]

   To assess the efficacy of neoadjuvant FOLFIRINOX chemotherapy followed by R0/R1 resection in patients with hepatic or pulmonary oligometastatic adenocarcinoma of the pancreas

Secondary Outcome Measures

1. R0/R1 resection rate after neoadjuvant chemotherapy [48 months]

   Determine the rate of complete (R0) and near-complete (R1) tumor resections following neoadjuvant chemotherapy.

2. Overall Survival [48 months]

   Assess the overall survival of patients receiving neoadjuvant chemotherapy for pancreatic cancer.

3. Progression-Free Survival (PFS) after R0/R1 Resection (RECIST v1.1) [48 months]

   Analyze the progression-free survival (PFS) in patients who achieve R0/R1 resection status, as per the RECIST v1.1 criteria, following neoadjuvant chemotherapy.

Other Outcome Measures

1. Health Related Quality of Life (HR-QoL) adjusted Overall Survival if enrolled in the separate Institutional Review Board protocol for QoL [48 months]

   Analyze the HR-QoL-adjusted overall survival if enrolled in the separate Institutional Review Board protocol for QoL

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Histologically confirmed diagnosis of treatment-naïve limited hepatic or pulmonary metastatic adenocarcinoma of the pancreas

2. Meet the definition of limited hepatic or pulmonary metastasis according to CT/MRI that is done prior to the starting of any anticancer treatment. Either CT scan of chest, abdomen, and pelvis with intravenous contrast or a combination of MRI of abdomen and pelvis and CT scan of chest is acceptable radiographic imaging. CT/MRI can be done at an outside facility, but must be reviewed by a Johns Hopkins Medicine radiologist.

3. Measurable disease according to RECIST v1.1

4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1

5. Being a candidate for the chemotherapy with FOLFIRINOX or modified FOLFIRINOX

6. Patients ≥18 years at the time of signing the informed consent

7. Patient's written informed consent prior to any trial-specific procedure

8. Patient's legal capacity to consent to participation in the clinical trial

Exclusion Criteria:

1. Acinar cell carcinoma and/or neuroendocrine carcinoma of the pancreas

2. Symptomatic clinically significant ascites

3. Evidence of any distant metastases other than limited hepatic or pulmonary metastasis as defined in inclusion criterion 1.

4. Evidence of simultaneous pulmonary and hepatic metastases

5. Any tumor-specific pretreatment of the adenocarcinoma of the pancreas (including but not limited to surgery, radiation therapy, chemotherapy or ablative procedures). Currently being on FOLFIRINOX or modified FOLFIRINOX (mFOLFIRINOX) is allowed, unless more than 2 treatments of FOLFIRINOX or mFOLFIRINOX has been given.

6. Any malignancies other than adenocarcinoma of the pancreas in the 2 years before the start of the clinical trial except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, breast cancer, prostate cancer or superficial bladder tumors (Ta, Tis and T1)

7. Known HIV seropositivity

8. Known active or chronic Hepatitis B or Hepatitis C infection

9. Any other severe concomitant disease or disorder, which could influence patient's ability to participate in the clinical trial and his/her safety during the trial or interfere with interpretation of results, e.g., severe hepatic, renal, pulmonary, cardiovascular, metabolic or psychiatric disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Investigators

• Principal Investigator: Jin He, MD, PhD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• ClinicalTrials.gov Identifier: NCT06122480
• Other Study ID Numbers: IRB00414679
• First Posted: Nov 8, 2023
• Last Update Posted: Nov 8, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: FOLFIRINOX; Irinotecan; Oxaliplatin
• Additional relevant MeSH terms: Adenocarcinoma; Folfirinox

Study Results

No Results Posted as of Nov 8, 2023