mFOLFOX Versus mFOLFIRI Versus FOLFPTX as First-line Treatment in AGC or EGJA
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
1 other identifier
interventional
150
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2017
CompletedFirst Posted
Study publicly available on registry
February 7, 2017
CompletedStudy Start
First participant enrolled
February 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedFebruary 7, 2017
January 1, 2017
2.9 years
January 31, 2017
February 4, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Progression-Free Survival (PFS)
24 months
Adverse Event（AE）
NCI CTC 4.03
35 months
Secondary Outcomes (4)
Objective Response Rate (ORR)
24 months
Disease Control Rate (DCR)
24 months
Overall Survival (OS)
35 months
Quality of Life (QoL)
35 months
Study Arms (3)
mFOLFOX
EXPERIMENTALThe 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.
mFOLFIRI
EXPERIMENTALThe 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.
FOLFPTX
EXPERIMENTALThe 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.
Interventions
Fluorouracil was used as first line treatment with AGC.
Calcium levofolinate was used as first line treatment with AGC.
Eligibility Criteria
You may qualify if:
- Age：18\~70years.
- Subjects with Histologically or cytologically confirmed advanced or metastatic gastric cancer or adenocarcinoma of gastroesophageal junction.
- First-line treatment patients.
- subjects with at least one measurable lesion as defined by RECIST (version 1.1).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Survival expectation≥ 3 months.
- No serious concomitant diseases(including heart,lung,liver jaundice or gastrointestinal obstruction and so on ).
- Adequate organ functions defined as indicated below： （1）Adequate bone marrow function, defined as: (no blood transfusion within 14 days)
- Hemoglobin (Hb)≥80g/L，
- White blood count (WBC)≥3.5×109/L
- Absolute neutrophil count (ANC)≥1.5×109/L，
- Platelet count (PLT)≥75×109/L； （2）Adequate liver function, defined as:
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- Bilirubin ≤1.5×the upper limit of normal (ULN)
- 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 more criteria
You may not qualify if:
- Females are lactating or pregnant at Screening or Baseline.
- 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).
- 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.
- Patients with brain or central nervous system metastases, including leptomeningeal disease.
- 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.
- History of a stroke or CVA within 6 months.
- Inability to comply with study and/or follow-up procedures.
- Patients with any other condition that in the opinion of the investigator would preclude his/her participation in a clinical study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jianwei Yang
Fuzhou, Fujian, 350000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianwei Yang
Fujian Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2017
First Posted
February 7, 2017
Study Start
February 10, 2017
Primary Completion
December 30, 2019
Study Completion
December 30, 2019
Last Updated
February 7, 2017
Record last verified: 2017-01