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NeoFOL-R Trial (Perioperative Versus Adjuvnat FOLFIRINOX in Resectable Pancreatic Cancer)

Primary Purpose

Resectable Pancreatic Cancer, Neoadjuvant Chemotherapy, Effects of Chemotherapy

Status

Not yet recruiting

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Folfirinox

About this trial

This is an interventional treatment trial for Resectable Pancreatic Cancer

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- A. Age: 18 to 80 years old B. Patients with a score of 0 - 2 (ECOG) when selecting a study subject C. Pancreatic ductal adenocarcinoma diagnosed by histological examination (histologic or cytopathological) D. Patients evaluated as resectable pancreatic cancer in preoperative imaging as follows (NCCN guidelines for pancreatic adenocarcinoma version 2.2021)

No arterial tumor contact (celiac asix, superior mesenteric artery, or common hepatic artery).
No tumor contact with the superior mesenteric vein or portal vein or ≤ 180°contact without vein contour irregularity.

E. No distant metastases on preoperative imaging F. Patients with adequate organ function

Bone marrow function: WBC 3,000/mm3 or more or ANC 1,500/mm3 or more, platelet ≥ 100K/mm3
Liver function: Bilirubin ≤ 3 x upper normal limit (≤5.0 mg/dL), AST/ALT ≤ 5 x upper normal limit (<200 IU/L)
Renal function (Cr clearance ≥ 60 mL/min) or (Cr < 1.5 x upper normal limit) G. Persons physically capable of undergoing surgery H. Those who consented to the clinical trial

Exclusion Criteria:

- Patients who met any of the following criteria are not eligible to participate in this study.

A. Those evaluated as borderline resectable or locally advanced pancreatic cancer in preoperative imaging examination B. Patients with a history of previous pancreatic surgery C. Patients with a history of previous chemotherapy or radiation therapy for pancreatic cancer D. Patients with distant metastases or recurrent pancreatic cancer E. Pancreatic body or tail cancer requiring combined resection of adjacent organs (stomach or kidney) (except for the adrenal gland) F. Patients within five years of diagnosis of other organ malignancies (with the exception of adequately treated non-melanoma skin cancer and carcinoma in situ without evidence of disease) G. Pregnant and lactating women H. Serious concomitant systemic disorders that would compromise the safety of the patient or patient's ability to complete the study at the discretion of the investigator

Sites / Locations

Department of Internal Medicine, Seoul St. Mary's Hospital, Catholic University College of Medicine
Department of Surgery, Seoul National University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neoadjuvant FOLFIRINOX

Upfront Surgery

Arm Description

6 cycles of neoadjuvant mFOLFIRINOX followed by surgical resection and 6 cycles of adjuvant mFOLFIRINOX

surgical resection followed by 12 cycles of adjuvant mFOLFIRINOX

Outcomes

Primary Outcome Measures

2-year survival rate

The primary objective of this trial is to investigate whether 6 cycles of preoperative mFOLFIRINOX - surgery - 6 cycles of postoperative mFOLFIRINOX improves overall survival by intention-to-treat compared to surgery followed by 12 cycles of postoperative mFOLFIRINOX.

Secondary Outcome Measures

Overall survival

Defined as the time from the date of randomization to the date of death from any cause. Patients who were not reported dead at the time of analysis were censored on the last day they were known to be alive.

Resection rate

Referred to the proportion of patients who underwent curative resection

R0 resection rate

Referred to the proportion of patients with microscopically negative resection margins due to the pathological examinations after the surgery. In this case, R0 indicated that no tumor was observed within 0 mm from the margins of resection.

Disease free survival

Defined as the time between the date of randomization and the occurrence of distant metastases, locoregional progression, or death from any cause. Patients who were alive and free of these events at the last follow-up would be censored.

Recurrence rate

Local recurrence is defined as recurrence in the pancreatic resection margin, residual pancreas, and regional lymph nodes, and distant metastasis is defined as recurrence in a distant organ. The local recurrence and distant metastasis rates are defined as the percentage of patients who had recurrence after the surgical resection.

Response rate in neoadjuvant setting

Defined as the percentage of patients who showed complete response, partial response, and stable disease after three or six cycles of scheduled chemotherapy. The evaluation is based on RECIST v.1.1.

Full Information

NCT ID

NCT05529940

First Posted

September 2, 2022

Last Updated

August 5, 2023

Sponsor

Seoul National University Hospital

Collaborators

Seoul St. Mary's Hospital, Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center, Gangnam Severance Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05529940

Brief Title

NeoFOL-R Trial (Perioperative Versus Adjuvnat FOLFIRINOX in Resectable Pancreatic Cancer)

Official Title

Efficacy of Perioperative Versus Adjuvant FOLFIRINOX in Resectable Pancreatic Cancer: an International Multicenter Randomized Controlled Trial (NeoFOL-R Trial)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 2023 (Anticipated)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

Collaborators

Seoul St. Mary's Hospital, Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center, Gangnam Severance Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Rationale: Adjuvant chemotherapy after surgery significantly improved the survival of PC patients, but there is a problem that only about 50% of patients start adjuvant chemotherapy after pancreatectomy. Neoadjuvant chemotherapy might control potential metastatic lesion which are not being detected in early diseases status and improve the R0 resection rate. In addition, it prevents futile surgery by selecting patients with rapid progression of disease. Furthermore, compared to chemotherapy administered after surgery, more patients can complete the planned chemotherapy schedule in neoadjuvant setting. Asians differ from Westerners not only in racial differences, but also in average size and body surface area. Accordingly, there is an urgent need for clinical studies on the dose, toxicity, dosing cycle, and efficacy of anticancer drugs that reflect actual clinical trials in Asian countries for Asians. There are still few studies worldwide that prospectively explored the efficacy of neoadjuvant chemotherapy in resectable PC and the administration of neoadjuvant therapy in resectable PC depends on individual clinical judgment. Therefore, systematic and prospective clinical trials are essential to standardize treatment protocol in resectable PC. Obective: To investigate whether 6 cycles of preoperative mFOLFIRINOX - surgery - 6 cycles of postoperative mFOLFIRINOX improves overall survival by intention-to-treat compared to surgery followed by 12 cycles of postoperative mFOLFIRINOX. Study design: open-label, multicenter, randomized, phase 3 clinical trial Study population: Patients with resectable pancreatic cancer and ECOG performance 0 or 1. Intervention: Invervention arm : 6 cycles of neoadjuvant mFOLFIRINOX followed by surgical resection and 6 cycles of adjuvant mFOLFIRINOX Comparator arm : surgical resection followed by 12 cycles of adjuvant mFOLFIRINOX Primary endpoint: 2-year overall survival rate by intention-to-treat

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Resectable Pancreatic Cancer, Neoadjuvant Chemotherapy, Effects of Chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

609 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Neoadjuvant FOLFIRINOX

Arm Type

Experimental

Arm Description

6 cycles of neoadjuvant mFOLFIRINOX followed by surgical resection and 6 cycles of adjuvant mFOLFIRINOX

Arm Title

Upfront Surgery

Arm Type

Active Comparator

Arm Description

surgical resection followed by 12 cycles of adjuvant mFOLFIRINOX

Intervention Type

Drug

Intervention Name(s)

Folfirinox

Intervention Description

The primary aim of this trial was to investigate whether six cycles of preoperative mFOLFIRINOX followed by six cycles of postoperative mFOLFIRINOX improved the overall survival rate by intention-to-treat compared to surgery followed by 12 cycles of postoperative mFOLFIRINOX.

Primary Outcome Measure Information:

Title

2-year survival rate

Description

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Overall survival

Description

Time Frame

5 years

Title

Resection rate

Description

Referred to the proportion of patients who underwent curative resection

Time Frame

3 years

Title

R0 resection rate

Description

Time Frame

3 years

Title

Disease free survival

Description

Time Frame

3 years

Title

Recurrence rate

Description

Time Frame

3 years

Title

Response rate in neoadjuvant setting

Description

Defined as the percentage of patients who showed complete response, partial response, and stable disease after three or six cycles of scheduled chemotherapy. The evaluation is based on RECIST v.1.1.

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - A. Age: 19 to 80 years old B. Patients with a score of 0 - 2 (ECOG) when selecting a study subject C. Pancreatic ductal adenocarcinoma diagnosed by histological examination (histologic or cytopathological) D. Patients evaluated as resectable pancreatic cancer in preoperative imaging as follows (NCCN guidelines for pancreatic adenocarcinoma version 2.2021) No arterial tumor contact (celiac asix, superior mesenteric artery, or common hepatic artery). No tumor contact with the superior mesenteric vein or portal vein or ≤ 180°contact without vein contour irregularity. E. No distant metastases on preoperative imaging F. Patients with adequate organ function Bone marrow function: WBC 3,000/mm3 or more or ANC 1,500/mm3 or more, platelet ≥ 100K/mm3 Liver function: Bilirubin ≤ 3 x upper normal limit (≤5.0 mg/dL), AST/ALT ≤ 5 x upper normal limit (<200 IU/L) Renal function (Cr clearance ≥ 60 mL/min) or (Cr < 1.5 x upper normal limit) G. Persons physically capable of undergoing surgery H. Those who consented to the clinical trial Exclusion Criteria: - Patients who met any of the following criteria are not eligible to participate in this study. A. Those evaluated as borderline resectable or locally advanced pancreatic cancer in preoperative imaging examination B. Patients with a history of previous pancreatic surgery C. Patients with a history of previous chemotherapy or radiation therapy for pancreatic cancer D. Patients with distant metastases or recurrent pancreatic cancer E. Pancreatic body or tail cancer requiring combined resection of adjacent organs (stomach or kidney) (except for the adrenal gland) F. Patients within five years of diagnosis of other organ malignancies (with the exception of adequately treated non-melanoma skin cancer and carcinoma in situ without evidence of disease) G. Pregnant and lactating women H. Serious concomitant systemic disorders that would compromise the safety of the patient or patient's ability to complete the study at the discretion of the investigator

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jin-Young Jang

Phone

+82-2-2072-2194

jyjang4@snu.ac.kr

First Name & Middle Initial & Last Name or Official Title & Degree

Myung-Ah Lee

angelamd@catholic.ac.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wooil Kwon

Organizational Affiliation

Seoul National University Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Department of Internal Medicine, Seoul St. Mary's Hospital, Catholic University College of Medicine

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Myung-Ah Lee, M.D., Ph.D.

Phone

+82-3210-3125

angelamd@gatholic.ac.kr

First Name & Middle Initial & Last Name & Degree

Myung-Ah Lee, M.D., Ph.D.

First Name & Middle Initial & Last Name & Degree

Se Jun Park, M.D.

Facility Name

Department of Surgery, Seoul National University College of Medicine

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

NeoFOL-R Trial (Perioperative Versus Adjuvnat FOLFIRINOX in Resectable Pancreatic Cancer)

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