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Back to Stomach Cancer
Phase 3 Stomach Cancer Trial, Recruiting
NCT03961373
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:
- People aged 18 or older
- People with a confirmed diagnosis of primary stomach cancer (stage IIA to IIIC, based on tissue testing), before starting chemotherapy treatment, and who have not had any previous surgery or chemotherapy for this cancer
- People whose CT scan shows no spread of cancer to the chest lymph nodes, lungs, lining of the abdomen, liver, fluid around the lungs or abdomen, specific abdominal lymph node groups (para-aortic 16a2/b1, posterior groups 8p, 12b/p, 13), or other distant lymph nodes
- People with a general health and activity level rated at ECOG 2 or below (meaning able to carry out some daily activities independently) (confirm with trial site)
- People who have not had prior radiotherapy or chemotherapy that would conflict with stomach cancer treatment
- People with no spread of cancer into the oesophagus (food pipe), or where any such spread is 3cm or less
- People whose keyhole staging procedure (laparoscopy) found no cancer cells in the abdominal fluid and no spread to the abdominal lining
- People who do not have cancer in a remnant stomach from previous surgery
- People with no signs of cancer in neck or collarbone lymph nodes, or distant spread
- People who have signed and dated a consent form before any study procedures begin
- People without psychological, family, social, or geographical circumstances that could prevent them from following the study schedule (this is discussed with the patient before registration)
Who may not be able to join:
- People for whom chemotherapy is medically unsuitable according to local treatment standards
- People with a diffuse, thickened form of stomach cancer known as linitis plastica
- People with a second cancer that is not controlled, whether occurring at the same time or within the last 5 years (except very early-stage surface cancers)
- People whose cancer involves the junction between the oesophagus and stomach (classified as Siewert type I or II)
- People whose cancer is expected to remain unable to be surgically removed after pre-surgery chemotherapy, or where the cancer has progressed to spread further
- People needing emergency surgery due to bleeding or a hole (perforation) in the stomach
- People with an active, uncontrolled infection
- People with other serious medical conditions that could prevent safe participation in the study
- People who are pregnant or breastfeeding
- People with significant neurological or psychiatric conditions
- People with severe heart disease (classified as NYHA Class IV — meaning severe limitation of physical activity) (confirm with trial site)
- People currently being treated with steroid medication taken throughout the body (systemic steroids)
- People already participating in another clinical trial that could affect the results of this study
- People unlikely to be able to follow the study requirements as directed
- People unable to complete questionnaires due to language barriers, dementia, or other difficulties
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.
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.
Contact this trial
Principal Investigator: Franco Roviello, University of Siena
Phone: +39577585157
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
Phase 3
Sponsor
University of Siena
Registry
ClinicalTrials.gov
Start date
5 November 2018
Est. completion
1 November 2023
Where this trial is recruiting
🇮🇹 Italy
Primary endpoints
Overall survival analysis
Can't join this trial?
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.