Stomach Cancer Trial, Recruiting NCT04595929 Sponsor: St. Petersburg State Pavlov Medical University Condition: Stomach Cancer
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Stomach Cancer Trial, Recruiting

NCT04595929
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with stomach cancer (specifically a type called adenocarcinoma) that has been confirmed by a tissue sample, and doctors believe it can be surgically removed.
  • Your cancer is at a stage where it has grown into or through the stomach wall (but has not spread to distant parts of the body), based on scans.
  • You have not had any chemotherapy, targeted therapy, or surgery to remove any part of your tumor before joining this trial.
  • You are between 18 and 75 years old.
  • If you are a woman who could become pregnant, you must have a negative pregnancy test within 7 days before the trial starts, and you must agree to use highly effective contraception throughout the study.
  • If you are a man, you must agree to use a condom during treatment and not to father a child during the study, and your partner (if she could become pregnant) must also use effective contraception.
  • You are reasonably well and able to carry out daily activities (confirm with trial site for exact fitness level required).
  • Scans (CT or MRI) have confirmed that the cancer has not spread to distant areas of the body, and has not grown into surrounding organs.
  • A keyhole surgical procedure (laparoscopy) has confirmed the cancer has not spread to the lining of the abdomen before chemotherapy begins.
  • Your blood counts, liver function, and kidney function are within acceptable levels (confirm with trial site for exact values).
  • You are willing and able to give written consent and follow the study plan, including planned surgery.

Who may not be able to join:

  • You have not received any pre-surgery (neoadjuvant) chemotherapy, or you received a different chemotherapy regimen other than FLOT before joining.
  • You have a known allergy or sensitivity to any of the chemotherapy drugs used in FLOT (5-FU, leucovorin, oxaliplatin, or docetaxel).
  • You have any other known medical reason why you cannot take the FLOT chemotherapy drugs.
  • You have significant active heart disease, a serious heart muscle condition, or severe heart failure (confirm with trial site for exact definition).
  • You have a significant heart valve problem.
  • Your cancer has grown into major blood vessels or nearby organs, or has spread to certain lymph nodes in the abdomen that are considered distant spread.
  • You have another serious illness or an active infection.
  • You have significant nerve damage in your hands or feet (confirm with trial site for exact definition).
  • You have had major surgery within 28 days before joining the trial (a staging laparoscopy is an exception).
  • You have significant liver scarring (cirrhosis) at a certain level of severity, or any cirrhosis combined with a history of brain complications from liver disease or fluid build-up in the abdomen.
  • You are currently taking part in, or have taken part in, another interventional clinical trial within 30 days before joining or during this study.
  • You are pregnant, breastfeeding, or planning to become pregnant.
  • You are receiving any other cancer treatment, including radiotherapy, at the same time.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Alexander Zakharenko, PhD, First Pavlov State Medical University of St. Petersburg

Phone: 9219516183

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
St. Petersburg State Pavlov Medical University
Registry
ClinicalTrials.gov
Start date
10 February 2020
Est. completion
10 October 2021

Where this trial is recruiting

🇷🇺 Russia

Primary endpoints

Comparison of Overall survival (OS) in both arms

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov