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Adenocarcinoma of the Stomach / GastroesophagealPhase 2NCT03451942

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

A Phase 2 study testing FLOT regimen chemotherapy and D2 gastric and imaging metastases resection in people with Adenocarcinoma of the Stomach / Gastroesophageal, run by Henan 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 The sponsor has not verified this record for over two years, so it may be out of date.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

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… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
FLOT regimen chemotherapy and D2 gastric and imaging metastases resection
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
112 participants
Where
1 siteChina
Study dates
5 Feb 2018to Mar 2021
Phase
Phase 2
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

  • Patients volunteered to participate in this study and signed informed consent.
  • Endoscopic biopsy or metastatic biopsy was confirmed to be the adenocarcinoma of the stomach / gastroesophageal.
  • Her - 2 negative(Including: Her protein detection -/1+, and Her protein 2+ but FISH negative).
  • Without any antitumor therapy;
  • 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;
  • Age from 18 to 70 years.
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  • Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1.
  • Life expectancy more than 12 weeks.
  • Histological specimens were provided for biological target detection of her-2;
  • Surgical patients agree to undergo surgery and sign an informed consent to perform the risk of surgery；
  • The main organ function meet the following criteria within 7 days before treatment:
  • blood routine examination( No blood transfusion within 14 days)
  • HB≥90g/L，
  • ANC≥1.5×109/L，
  • PLT≥80×109/L；
  • blood biochemical examination
  • TBIL <1.5 Upper Limit Of Normal（ULN）;
  • ALT and AST<2.5ULN(or ≤ 5×ULN in patients with liver metastases).
  • Cr≤1.5ULN or creatinine clearance>60ml/min.
  • Doppler ultrasonography: left ventricular ejection fraction (LVEF) was lower than normal (50%).
  • 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.

Who cannot join

  • 5 years or at the same time have other malignant tumors；
  • docetaxel or oxaliplatin and other research with chemotherapy drugs are serious allergy;
  • patients with severe cachexia can not eat and can not tolerate chemotherapy and surgery;
  • 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);
  • Patients with any severe and / or uncontrollable disease, including:
  • Patients with hypertension who are not well controlled by antihypertensive medication (systolic BP ≥150 mmHg, diastolic BP ≥100 mmHg);
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  • 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);
  • Severe infection that is active or uncontrollable (≥CTCAE grade 2 infection);
  • Renal failure requires hemodialysis or peritoneal dialysis;
  • Have a history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease, or history of organ transplants;
  • Poor glycemic control in diabetic patients (fasting blood glucose (FBG)> 10 mmol / L);
  • Patients with seizures who require treatment;
  • 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;
  • Within 4 weeks prior to enrollment, there were non-healing wounds, ulcers or fractures;
  • CNS metastasis;
  • Persons with psychiatric abuse who can not be abdicated or have mental disorders;
  • patients who have participated in other anti-cancer drug clinical trials within 4 weeks;
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

    Zhengzhou, Henan, 450008

Other trials in China

About this study

Official title: 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.

Being tested
FLOT regimen chemotherapy, D2 gastric and imaging metastases resection

What participants receive

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

  • FLOT regimen chemotherapyDrug

    FLOT regimen chemotherapy

  • D2 gastric and imaging metastases resectionProcedure or surgery

    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)

Study groups in NCT03451942
Study groupRoleWhat they receive
surgery group after FLOT regimen chemotherapyExperimentalAfter 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)
Receives: Drug: FLOT regimen chemotherapy; Procedure: D2 gastric and imaging metastases resection
FLOT regimen chemotherapyPlacebo comparatorContinue 4 cycles of the FLOT regimen chemotherapy and evaluate the efficacy every 8 weeks.
Receives: Drug: FLOT regimen chemotherapy

What is being measured

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

  1. Progression-free Survival (PFS)

    From date of randomization until the date of first documented progression or date of death from any cause

    Measured: up to 2 year

Secondary outcomes (3)

  1. Overall survival(OS)

    the first day of treatment to death or last survival confirm date

    Measured: up to 24 months

  2. Objective Response Rate (ORR)

    From date of randomization until the date of death from any cause

    Measured: up to 1 year

  3. R0 resection rate

    Tumor tissue was completely resected as a percentage of all surgical patients

    Measured: up to 1 year

Timeline

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

  1. First posted2 Mar 2018
  2. Study start5 Feb 2018
  3. Primary completionSep 2019 (estimated)
  4. Study completionMar 2021 (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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03451942
Sponsor's protocol ID
HNSZLG-GE-003
Status last verified
Feb 2018
First submitted
24 Feb 2018
Last updated
2 Mar 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FLOT regimen chemotherapy and D2 gastric and imaging metastases resection in people with Adenocarcinoma of the Stomach / Gastroesophageal, run by Henan 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 21 inclusion and 18 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 2 Mar 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: up to 2 year). 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 NCT03451942.

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 2 Mar 2018.

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