mFOLFOX Versus mFOLFIRI Versus FOLFPTX as First-line Treatment in AGC or EGJA

February 4, 2017 updated by: Fujian Cancer Hospital

A Randomized, Parallel Control Trial to Compare mFOLFOX Versus mFOLFIRI Versus FOLFPTX (a Combination of Paclitaxel, Fluorouracil) as First-line Treatment in Advanced Gastric Cancer or Adenocarcinoma of Esophagogastric Junction

The aim of this study was to compare the efficacy and safety of mFOLFOX, mFOLFIRI and FOLFPTX as first-line treatment in AGC or EGJA.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In previous studies, we found that mFOLFOX(a Combination of Oxaliplatin, Fluorouracil), mFOLFIRI(a Combination of Irinotecan, Fluorouracil), FOLFPTX (a Combination of Paclitaxel, Fluorouracil) are active in patients with AGC or EGJA.This study is being done to find out which one has the best efficacy.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

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 Contact Backup

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Jianwei Yang

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:

  1. Age：18~70years.
  2. Subjects with Histologically or cytologically confirmed advanced or metastatic gastric cancer or adenocarcinoma of gastroesophageal junction.
  3. First-line treatment patients.
  4. subjects with at least one measurable lesion as defined by RECIST (version 1.1).
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  6. Survival expectation≥ 3 months.
  7. No serious concomitant diseases(including heart,lung,liver jaundice or gastrointestinal obstruction and so on ).

  8. Adequate organ functions defined as indicated below： （1）Adequate bone marrow function, defined as: (no blood transfusion within 14 days)

    1. Hemoglobin (Hb)≥80g/L，
    2. White blood count (WBC)≥3.5×109/L
    3. Absolute neutrophil count (ANC)≥1.5×109/L，
    4. Platelet count (PLT)≥75×109/L； （2）Adequate liver function, defined as:
    1. Bilirubin ≤1.5×the upper limit of normal (ULN)
    2. Alanine aminotransferase (ALT), or Aspartate aminotransferase (AST) ≤3.0×(ULN), Glutamyl transpeptidase(GGT)≤2.5×(ULN), (When liver metastases, ALT or AST and GPT <5.0×(ULN)).
    3. serum creatinine ≤1.0×（ULN）, or creatinine clearance > 50 mL/min( calculated per the Cockcroft and Gault formula)
  9. Females of childbearing potential must be a pregnancy test in 7 days before participating ( including serum or urine), and the results were negative, Females of childbearing potential must agree to use a highly effective method of contraception throughout the entire study period and for 8 weeks after study drug discontinuation. Male subjects must have had a successful vasectomy or they and their female partners must meet the criteria above (i.e.not of childbearing potential or practicing highly effective contraception throughout the study period and for 8 weeks after study drug discontinuation).
  10. Subjects provided written informed consent before participating,Willing and able to comply with all aspects of the protocol.

Exclusion Criteria:

  1. Females are lactating or pregnant at Screening or Baseline.
  2. Patients with other active malignancy (except for definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix).
  3. Patients who have received previous pre- or post-operative chemotherapy or chemoradiation are ineligible if therapy was completed less than 6 months prior to study registration. Patients must have recovered from adverse events from any previous therapy.
  4. Patients with brain or central nervous system metastases, including leptomeningeal disease.
  5. Significant cardiac disease as defined as:unstable angina, New York Heart Association (NYHA) grade II or greater, congestive heart failure, history of myocardial infarction within 6 months Evidence of bleeding diathesis or coagulopathy.
  6. History of a stroke or CVA within 6 months.
  7. Inability to comply with study and/or follow-up procedures.
  8. Patients with any other condition that in the opinion of the investigator would preclude his/her participation in a clinical 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: mFOLFOX
The mFOLFOX regimen consisted of oxaliplatin (85 mg/m2) and calcium levofolinate (200 mg/m2).Subsequently, a 48-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days till progressive disease or intolerable toxicities.
Drug: Fluorouracil
Fluorouracil was used as first line treatment with AGC.
Other Names:
  • 5-FU
Drug: Oxaliplatin
Oxaliplatin was used as first line treatment with AGC.
Other Names:
  • OXA
Drug: calcium levofolinate
Calcium levofolinate was used as first line treatment with AGC.
Experimental: mFOLFIRI
The mFOLFIRI regimen consisted of irinotecan (180 mg/m2) and calcium levofolinate (200 mg/m2).Subsequently, a 48-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days till progressive disease or intolerable toxicities.
Drug: Fluorouracil
Fluorouracil was used as first line treatment with AGC.
Other Names:
  • 5-FU
Drug: calcium levofolinate
Calcium levofolinate was used as first line treatment with AGC.
Drug: Irinotecan
Irinotecan was used as first line treatment with AGC.
Other Names:
  • CPT-11
Experimental: FOLFPTX
The FOLFPTX regimen consisted of paclitaxel (95 mg/m2) and calcium levofolinate (200 mg/m2).Subsequently, a 48-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days till progressive disease or intolerable toxicities.
Drug: Fluorouracil
Fluorouracil was used as first line treatment with AGC.
Other Names:
  • 5-FU
Drug: calcium levofolinate
Calcium levofolinate was used as first line treatment with AGC.
Drug: Paclitaxel
Paclitaxel was used as first line treatment with AGC.
Other Names:
  • PTX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: 24 months
24 months
Adverse Event（AE）
Time Frame: 35 months
NCI CTC 4.03
35 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Control Rate (DCR)
Time Frame: 24 months
24 months
Objective Response Rate (ORR)
Time Frame: 24 months
24 months
Overall Survival (OS)
Time Frame: 35 months
35 months
Quality of Life (QoL)
Time Frame: 35 months
Use the validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 [EORTC QLQ-C30].
35 months

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 (Anticipated)

February 10, 2017

Primary Completion (Anticipated)

December 30, 2019

Study Completion (Anticipated)

December 30, 2019

Study Registration Dates

First Submitted

January 31, 2017

First Submitted That Met QC Criteria

February 4, 2017

First Posted (Estimate)

February 7, 2017

Study Record Updates

Last Update Posted (Estimate)

February 7, 2017

Last Update Submitted That Met QC Criteria

February 4, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FJG201701

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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