Surgical Resection of Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma

Pancreatic Ductal Adenocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06122480
• Other study ID #: J23143
• Secondary ID: IRB00414679
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 13, 2024
• Est. completion date: April 1, 2028

Study information

• Verified date: April 2024
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: Jin He, MD, PhD
• Phone: +1(410)614-7551
• Email: jhe11[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 1, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Oligometastatic Disease
• Pancreatic Ductal Adenocarcinoma

Intervention

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

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival after R0/R1 resection (OS-res) (only patients with R0/R1 resection)	To assess the efficacy of neoadjuvant FOLFIRINOX chemotherapy followed by R0/R1 resection in patients with hepatic or pulmonary oligometastatic adenocarcinoma of the pancreas	48 months
Secondary	R0/R1 resection rate after neoadjuvant chemotherapy	Determine the rate of complete (R0) and near-complete (R1) tumor resections following neoadjuvant chemotherapy.	48 months
Secondary	Overall Survival	Assess the overall survival of patients receiving neoadjuvant chemotherapy for pancreatic cancer.	48 months
Secondary	Progression-Free Survival (PFS) after R0/R1 Resection (RECIST v1.1)	Analyze the progression-free survival (PFS) in patients who achieve R0/R1 resection status, as per the RECIST v1.1 criteria, following neoadjuvant chemotherapy.	48 months