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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03045770
Recruitment Status : Unknown
Verified January 2017 by Fujian Cancer Hospital.
Recruitment status was:  Not yet recruiting
First Posted : February 7, 2017
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Fujian Cancer Hospital

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.

Condition or disease Intervention/treatment Phase
Advanced Gastric Cancer Adenocarcinoma of Esophagogastric Junction Drug: Fluorouracil Drug: Oxaliplatin Drug: Irinotecan Drug: Paclitaxel Drug: calcium levofolinate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : February 10, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


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 Name: 5-FU

Drug: Oxaliplatin
Oxaliplatin was used as first line treatment with AGC.
Other Name: 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 Name: 5-FU

Drug: Irinotecan
Irinotecan was used as first line treatment with AGC.
Other Name: CPT-11

Drug: calcium levofolinate
Calcium levofolinate was used as first line treatment with AGC.

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 Name: 5-FU

Drug: Paclitaxel
Paclitaxel was used as first line treatment with AGC.
Other Name: PTX

Drug: calcium levofolinate
Calcium levofolinate was used as first line treatment with AGC.




Primary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: 24 months ]
  2. Adverse Event(AE) [ Time Frame: 35 months ]
    NCI CTC 4.03


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 24 months ]
  2. Disease Control Rate (DCR) [ Time Frame: 24 months ]
  3. Overall Survival (OS) [ Time Frame: 35 months ]
  4. 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].



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045770


Contacts
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Contact: Jianwei Yang 008613805097959 swzcq62@163.com
Contact: Sha Huang 008613763820570 huangsha0210@163.com

Locations
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China, Fujian
Jianwei Yang
Fuzhou, Fujian, China, 350000
Sponsors and Collaborators
Fujian Cancer Hospital
Investigators
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Principal Investigator: Jianwei Yang Fujian Cancer Hospital

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Responsible Party: Fujian Cancer Hospital
ClinicalTrials.gov Identifier: NCT03045770    
Other Study ID Numbers: FJG201701
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Calcium, Dietary
Leucovorin
Paclitaxel
Albumin-Bound Paclitaxel
Oxaliplatin
Irinotecan
Fluorouracil
Calcium
Levoleucovorin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents