A Randomized Phase III Study Comparing POF With SOX/CAPOX/FOLFOX as a Postoperative Adjuvant Chemotherapy for Curatively Resected Stage III Gastric Cancer

October 13, 2019 updated by: Fujian Cancer Hospital

A Randomized Phase III Study Comparing POF (Paclitaxel/Oxaliplatin/Leucovorin/5-FU) With SOX/CAPOX/FOLFOX as a Postoperative Adjuvant Chemotherapy for Curatively Resected Stage III Gastric Cancer

FNF-014 is a randomised, open-label, multicentre, parallel-group, phase 3 study in China to prove superiority of POF over S-1/docetaxel in postoperative adjuvant setting for pStage III gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Fuzhou, China, 350014
        • Recruiting
        • Rongbo Lin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 to 70 years.
  • Histologically proven in gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) of stage IIIA, IIIB, IIIC with no evidence of metastatic disease.
  • Subjects must be able to take orally.
  • R0 resection with D2 lymph-node dissection with al least 15 lymph nodes were examined to ensure adequate disease classification.
  • Previously untreated except for the initial gastric resection for the primary lesion.
  • ECOG performance status ≦ 1.
  • Able to start chemotherapy with 42 days after gastrectomy.
  • Hgb ≧ 9 g/dL, WBC 4000-12000/mm3, platelets ≧ 100,000/mm3
  • Creatine ≦ upper normal limit (UNL)
  • Total bilirubin ≦ 1.5 X UNL
  • AST, ALT and ALP ≦ 2.5 x UNL
  • Life expectancy estimated than 3 months
  • Written informed consent

Exclusion Criteria:

  • Active double cancer
  • Gastrointestinal bleeding
  • Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant
  • Definite contraindications for the use of corticosteroids
  • Any subject judged by the investigator to be unfit for any reason to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: POF
A 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and leucovorin (400 mg/m2), administered simultaneously over a 2-hour infusion period. Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating every 14 days for 12 cycles.
Drug: POF
A 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and leucovorin (400 mg/m2), administered simultaneously over a 2-hour infusion period. Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating every 14 days for 12 cycles.
Active Comparator: CAPOX/SOX/FOLFOX

CAPOX: IV oxaliplatin given over 120 min at a dose of 130 mg/m2 on day 1, oral capecitabine 1000 mg/m2 twice daily on days 1 through 14 every 21 days for 8 cycles.

SOX: Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO [BSA <1.25 40mg bid (total 80mg/day); BSA ≥1.25 - <1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid (total 120mg/day)], divided by two on D1-14 every 21 days for 8 cycles.

mFOLFOX6: IV oxaliplatin given over 120 min at a dose of 85 mg/m2 on day 1 followed by IV leucovorin 400 mg/m2 over 2h, IV bolus 5-Fluorouracil 400 mg/m2 and IV infusional 5-Fluorouracil 2400 mg/m2 over 46h every 14 days for 12 cycles.
Drug: CAPOX/SOX/FOLFOX

CAPOX: IV oxaliplatin given over 120 min at a dose of 130 mg/m2 on day 1, oral capecitabine 1000 mg/m2 twice daily on days 1 through 14 every 21 days for 8 cycles.

SOX: Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO [BSA <1.25 40mg bid (total 80mg/day); BSA ≥1.25 - <1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid (total 120mg/day)], divided by two on D1-14 every 21 days for 8 cycles.

mFOLFOX6: IV oxaliplatin given over 120 min at a dose of 85 mg/m2 on day 1 followed by IV leucovorin 400 mg/m2 over 2h, IV bolus 5-Fluorouracil 400 mg/m2 and IV infusional 5-Fluorouracil 2400 mg/m2 over 46h every 14 days for 12 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year disease-free survival
Time Frame: From enrollment to 5 years after treatment
The time from randomisation to the time of recurrence of the original gastric cancer, development of a new gastric cancer, or death from any cause
From enrollment to 5 years after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: From enrollment to 5 years after treatment
The time from the date of randomisation to date of death from any cause
From enrollment to 5 years after treatment
safety (The incidence of chemotherapy related adverse events)
Time Frame: From enrollment to 1 years after treatment
The incidence of chemotherapy related adverse events
From enrollment to 1 years after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

December 25, 2018

First Submitted That Met QC Criteria

December 26, 2018

First Posted (Actual)

December 27, 2018

Study Record Updates

Last Update Posted (Actual)

October 16, 2019

Last Update Submitted That Met QC Criteria

October 13, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNF 014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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