Triple-Drug chemo blitz aims to boost stomach cancer survival
NCT ID NCT03773367
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This phase 2 trial tests whether adding a third chemotherapy drug (irinotecan) to the standard two-drug regimen (FOLFOX) improves outcomes for patients with resectable stomach or gastroesophageal junction cancer. 60 participants receive the three-drug combo before and after surgery. The goal is to see if this stronger treatment leads to better tumor shrinkage and survival rates.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Fluorouracil, Oxaliplatin, and Irinotecan (a three-drug chemotherapy combination)
- What this could lead to
- If successful, this could lead to a more effective chemotherapy regimen for resectable stomach cancer, potentially improving survival and cure rates.
- What could go wrong
- This is a small, early-phase (phase 2) trial with only 60 participants. The added drug (irinotecan) may increase side effects without improving outcomes. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2018
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically verified, resectable gastric or gastroesophageal (GE) (gastroesophageal) junction (Siewert type I-III) adenocarcinoma Confirmation of patient operability by surgeon * Primary tumor, regional nodes, metastasis (TNM), 8th edition): cT2-4a or cN+, cM0 * Age: 18 years or older * World Health Organization (WHO) performance status ≤ 1 * Exclusion of peritoneal carcinomatosis (if clinically suspected) via laparoscopy * Adequate laboratory findings: * hematological: hemoglobin \> 90 g/L (transfusion is allowed to attain this), absolute neutrophil count (ANC) ≥ 1,5 x 109/L, platelets ≥ 75 x 109/L * hepatic: bilirubin ≤ 1.5 x upper limit of normal (ULN), alanine aminotransferase (ALAT) ≤ 3 x ULN * renal: creatinine ≤ 1.5 x ULN (upper limit of normal) * Fertile men and women must use highly effective means of contraception (failure rate \<1%) such as: * combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal administration) * progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable administration) * intrauterine device * intrauterine hormone-releasing system * bilateral tubal occlusion * vasectomised partner * sexual abstinence * Signed written informed consent * The patient must be able to comply with the protocol Exclusion Criteria: * Neuroendocrine or adenosquamous carcinoma * Prior oncological treatment or surgical resection for the present disease * Presence of other concurrent malignancies or previous malignancies within 5 years except for adequately treated basal or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix uteri * Clinically significant (i.e. active) cardiovascular disease e.g. myocardial infarction (≤ 6 months), unstable angina, New York Heart Association (NYHA) grade III-IV congestive heart failure * Active inflammatory bowel disease * Symptomatic peripheral neuropathy greater than grade 1 (CTCAE version 4.03) * Known hypersensitivity to any contents of the study drugs * Pregnancy (positive pregnancy test) and/or breast feeding * Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centrallasarettet i Växjö
Vaxjo, 352 34, Sweden
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Karolinska University Hospital
Stockholm, 141 86, Sweden
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Lund University Hospital
Lund, 221 85, Sweden
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Oslo University Hospital, Ullevål Hospital
Oslo, 0450, Norway