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Advanced Gastric Cancer Adenocarcinoma of Esophagogastric JunctionNCT03045770

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

A study testing Fluorouracil, Oxaliplatin and Irinotecan in people with Advanced Gastric Cancer Adenocarcinoma of Esophagogastric Junction, run by Fujian Cancer Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Fluorouracil, Oxaliplatin and Irinotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteChina
Study dates
10 Feb 2017to 30 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 18Show fewer
  • 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)).
  • serum creatinine ≤1.0×（ULN）, or creatinine clearance > 50 mL/min( calculated per the Cockcroft and Gault formula)
  • 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).
  • Subjects provided written informed consent before participating,Willing and able to comply with all aspects of the protocol.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Jianwei Yang contact

008613805097959

swzcq62@163.com

Sha Huang contact

008613763820570

huangsha0210@163.com

China1 site

  • Jianwei Yang

    Fuzhou, Fujian, 350000

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Fluorouracil, Oxaliplatin, Irinotecan, Paclitaxel, calcium levofolinate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FluorouracilDrug

    Also called 5-FU

    Fluorouracil was used as first line treatment with AGC.

  • OxaliplatinDrug

    Also called OXA

    Oxaliplatin was used as first line treatment with AGC.

  • IrinotecanDrug

    Also called CPT-11

    Irinotecan was used as first line treatment with AGC.

  • PaclitaxelDrug

    Also called PTX

    Paclitaxel was used as first line treatment with AGC.

  • calcium levofolinateDrug

    Calcium levofolinate was used as first line treatment with AGC.

Study groups in NCT03045770
Study groupRoleWhat they receive
mFOLFOXExperimentalThe 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.
Receives: Drug: Fluorouracil; Drug: Oxaliplatin; Drug: calcium levofolinate
mFOLFIRIExperimentalThe 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.
Receives: Drug: Fluorouracil; Drug: Irinotecan; Drug: calcium levofolinate
FOLFPTXExperimentalThe 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.
Receives: Drug: Fluorouracil; Drug: Paclitaxel; Drug: calcium levofolinate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS)

    Measured: 24 months

  2. Adverse Event（AE）

    NCI CTC 4.03

    Measured: 35 months

Secondary outcomes (4)

  1. Objective Response Rate (ORR)

    Measured: 24 months

  2. Disease Control Rate (DCR)

    Measured: 24 months

  3. Overall Survival (OS)

    Measured: 35 months

  4. Quality of Life (QoL)

    Use the validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 [EORTC QLQ-C30].

    Measured: 35 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2017 (estimated)
  2. Study start10 Feb 2017 (estimated)
  3. Primary completion30 Dec 2019 (estimated)
  4. Study completion30 Dec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03045770
Sponsor's protocol ID
FJG201701
Status last verified
Jan 2017
First submitted
31 Jan 2017
Last updated
7 Feb 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Fluorouracil, Oxaliplatin and Irinotecan in people with Advanced Gastric Cancer Adenocarcinoma of Esophagogastric Junction, run by Fujian Cancer Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jianwei Yang (008613805097959, swzcq62@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03045770.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2017.

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