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
Overview
- Phase
- Not Applicable
- Intervention
- Fluorouracil
- Conditions
- Advanced Gastric Cancer Adenocarcinoma of Esophagogastric Junction
- Sponsor
- Fujian Cancer Hospital
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Progression-Free Survival (PFS)
- Last Updated
- 9 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •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
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: Fluorouracil
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.
Intervention: Oxaliplatin
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.
Intervention: calcium levofolinate
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.
Intervention: Fluorouracil
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.
Intervention: Irinotecan
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.
Intervention: calcium levofolinate
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.
Intervention: Fluorouracil
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.
Intervention: Paclitaxel
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.
Intervention: calcium levofolinate
Outcomes
Primary Outcomes
Progression-Free Survival (PFS)
Time Frame: 24 months
Adverse Event（AE）
Time Frame: 35 months
NCI CTC 4.03
Secondary Outcomes
- Disease Control Rate (DCR)(24 months)
- Overall Survival (OS)(35 months)
- Objective Response Rate (ORR)(24 months)
- Quality of Life (QoL)(35 months)