The FLOT Regimen Conversion Therapy of Adenocarcinoma of the Stomach / Gastroesophageal

February 26, 2018 updated by: LiuYing, Henan Cancer Hospital

The Clinical Study of FLOT Regimen Conversion Therapy of Her-2 Negative and Single Site Metastasis Adenocarcinoma of the Stomach / Gastroesophageal

Evaluate survival benefit of surgical treatment after FLOT regimen conversion therapy of Her-2 Negative and single site metastasis adenocarcinoma of the stomach / gastroesophageal compared with chemotherapy, use relevant biomarkers to evaluate the efficacy of chemotherapy and seek for patients with Her-2 negative and metastatic adenocarcinoma of the stomach / gastroesophageal surviving benefit from surgical treatment after the FLOT regimen conversion therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • ZhengZhou, Henan, China, 450008
        • Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients volunteered to participate in this study and signed informed consent.
  2. Endoscopic biopsy or metastatic biopsy was confirmed to be the adenocarcinoma of the stomach / gastroesophageal.
  3. Her - 2 negative(Including: Her protein detection -/1+, and Her protein 2+ but FISH negative).
  4. Without any antitumor therapy;
  5. According to the 7th edition of AJCC, imaging (CT/MRI) confirmed that the adenocarcinoma of the stomach / gastroesophageal with the initial single site metastasis had a detectable lesion (according to the RECIST 1.1 standard); Single site metastasis includes: liver, spleen, pancreas, ovary, retroperitoneal lymph node (16a1/b2), adrenal gland, kidney;
  6. Age from 18 to 70 years.
  7. Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1.
  8. Life expectancy more than 12 weeks.
  9. Histological specimens were provided for biological target detection of her-2;
  10. Surgical patients agree to undergo surgery and sign an informed consent to perform the risk of surgery；

  11. The main organ function meet the following criteria within 7 days before treatment:

    • blood routine examination( No blood transfusion within 14 days)

      1. HB≥90g/L，
      2. ANC≥1.5×109/L，
      3. PLT≥80×109/L；

    • blood biochemical examination

      1. TBIL <1.5 Upper Limit Of Normal（ULN）;
      2. ALT and AST<2.5ULN(or ≤ 5×ULN in patients with liver metastases).
      3. Cr≤1.5ULN or creatinine clearance>60ml/min.
    • Doppler ultrasonography: left ventricular ejection fraction (LVEF) was lower than normal (50%).
  12. Female subjects of child-bearing potential should agree to use contraceptive measures (such as intrauterine contraceptives, contraceptives or condoms) within six months of the study period and the end of the study. The serum or urine pregnancy test was negative within 7 days prior to the study and must be non-lactation. Men subjects should agree to use contraceptives in the study period and within six months at the end of the study period.

Exclusion Criteria:

  1. 5 years or at the same time have other malignant tumors；
  2. docetaxel or oxaliplatin and other research with chemotherapy drugs are serious allergy;
  3. patients with severe cachexia can not eat and can not tolerate chemotherapy and surgery;
  4. During the screening period, there was an unknown cause of fever before the first administration and the body temperature was> 38.5 ° C (as judged by the investigators, cancer-related fever subjects could be enrolled);

  5. Patients with any severe and / or uncontrollable disease, including:

    1. Patients with hypertension who are not well controlled by antihypertensive medication (systolic BP ≥150 mmHg, diastolic BP ≥100 mmHg);
    2. Myocardial ischemia or myocardial infarction with grade I or above, arrhythmia (including QTc≥480 ms) and ≥2 grade congestive heart failure (New York Heart Association (NYHA) classification);
    3. Severe infection that is active or uncontrollable (≥CTCAE grade 2 infection);
    4. Renal failure requires hemodialysis or peritoneal dialysis;
    5. Have a history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease, or history of organ transplants;
    6. Poor glycemic control in diabetic patients (fasting blood glucose (FBG)> 10 mmol / L);
    7. Patients with seizures who require treatment;
  6. Currently there are gastrointestinal diseases such as intestinal obstruction (including incomplete intestinal obstruction) or the researchers determine the patients may cause gastrointestinal bleeding, perforation or obstruction;
  7. Within 4 weeks prior to enrollment, there were non-healing wounds, ulcers or fractures;
  8. CNS metastasis;
  9. Persons with psychiatric abuse who can not be abdicated or have mental disorders;
  10. patients who have participated in other anti-cancer drug clinical trials within 4 weeks;
  11. According to the judgment of the researcher, there is a concomitant disease which seriously endangers the safety of the patient or affects the patient in completing the 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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: surgery group after FLOT regimen chemotherapy
After received 4 cycles FLOT regimen chemotherapy , D2 gastric resection and imaging metastases resection was performed. Then continue 4 cycles of FLOT regimen chemotherapy (Chemotherapy begins within 4-6 weeks after surgery)
Drug: FLOT regimen chemotherapy
FLOT regimen chemotherapy
Procedure: D2 gastric and imaging metastases resection
After received 4 cycles FLOT regimen chemotherapy , D2 gastric resection and imaging metastases resection was performed. Then continue 4 cycles of FLOT regimen chemotherapy (Chemotherapy begins within 4-6 weeks after surgery)
Placebo Comparator: FLOT regimen chemotherapy
Continue 4 cycles of the FLOT regimen chemotherapy and evaluate the efficacy every 8 weeks.
Drug: FLOT regimen chemotherapy
FLOT regimen chemotherapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS)
Time Frame: up to 2 year
From date of randomization until the date of first documented progression or date of death from any cause
up to 2 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: up to 1 year
From date of randomization until the date of death from any cause
up to 1 year
Overall survival(OS)
Time Frame: up to 24 months
the first day of treatment to death or last survival confirm date
up to 24 months
R0 resection rate
Time Frame: up to 1 year
Tumor tissue was completely resected as a percentage of all surgical patients
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Henan Cancer Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ying Liu, Henan 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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 5, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HNSZLG-GE-003

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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