Trial reportGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2020
Randomized phase II/III study of 5-fluorouracil/l-leucovorin versus 5-fluorouracil/l-leucovorin plus paclitaxel administered to patients with severe peritoneal metastases of gastric cancer (JCOG1108/WJOG7312G).
Trial report in Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
39 citing papers in PubMed, 3 syntheses or guidelines pooled it, 48 citations in OpenAlex.
- Gastrointestinal CancerEmerging treatment modalities for gastric cancer with peritoneal metastases: a systematic review.The oncologist · 2025Pooled it
- Executive Summary of the American Radium Society Appropriate Use Criteria for the Management of Peritoneal Carcinomatosis From Different Tumor Origins: Systematic Review and Guidelines.Cancer medicine · 2025Pooled it
- Clinical practice guideline for the treatment of malignant ascites: section summary in Clinical Practice Guideline for peritoneal dissemination (2021).International journal of clinical oncology · 2022Pooled it
- A multicenter Phase II study of mFOLFOX6 plus nivolumab for gastric cancer with severe peritoneal metastases: WJOG16322G.Future oncology (London, England) · 2025Trial
- Differences in efficacy of biweekly irinotecan plus cisplatin versus irinotecan alone in second-line treatment of advanced gastric cancer with or without prior gastrectomy.International journal of clinical oncology · 2025Trial
- Phase II Study of Intraperitoneal Administration of Paclitaxel Combined with S-1 and Cisplatin for Gastric Cancer with Peritoneal Metastasis.Annals of surgical oncology · 2024Trial
- Clinical implications of using both fluoropyrimidine and paclitaxel in patients with severe peritoneal metastasis of gastric cancer: A post hoc study of JCOG1108/WJOG7312G.Cancer medicine · 2021Trial
- Clinical Impact of Trastuzumab Deruxtecan in Patients With HER2-Positive Advanced Gastric Cancer and Ascites: Findings From the EN-DEAVOR Study.Journal of gastric cancer · 2026Article
- Catheter based intraperitoneal chemotherapy using taxane for peritoneal metastases from gastric cancer: from bench to bedside-a narrative review.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2026Review
- Phase II study of mFOLFOX6 in advanced gastric cancer patients with severe peritoneal metastases (WJOG10517G), including an individual patient data comparison with JCOG1108/WJOG7312G.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2026Article
- Efficacy and safety of nivolumab plus chemotherapy in patients with advanced gastric cancer with massive ascites.World journal of gastrointestinal oncology · 2026Article
- Intraperitoneal and intravenous paclitaxel plus S-1 and sintilimab as first-line treatment for gastric cancer with peritoneal metastasis: a single-arm phase 2 trial (DRAGON-09).EClinicalMedicine · 2026Article
- Efficacy and safety of taxane plus ramucirumab for advanced gastric cancer after chemotherapy plus nivolumab.Scientific reports · 2025Article
- Article
- Advances in Intraperitoneal Chemotherapy for Gastric Cancer Patients with Peritoneal Metastases: Current Status of Treatment and Institutional Insights.Journal of clinical medicine · 2025Article
- Impact of gastrectomy on efficacy and safety of second-line chemotherapy patients with advanced gastric cancer: Exploratory analysis of two randomized phase III trials.Annals of gastroenterological surgery · 2025Article
- PI3 expression predicts recurrence after chemotherapy with DNA-damaging drugs in gastric cancer.The Journal of pathology · 2025Article
- Clinical efficacy of nivolumab-based therapy for HER2-negative diffuse-type advanced gastric or gastroesophageal junction adenocarcinoma with peritoneal dissemination.ESMO gastrointestinal oncology · 2025Article
- Preclinical toxicological assessment of amido-bridged nucleic acid-modified antisense oligonucleotides targeting synaptotagmin XIII for intra-abdominal treatment of peritoneal metastasis of gastric cancer.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2024Article
- Optimizing Timing of Intraperitoneal Chemotherapy to Enhance Intravenous Carboplatin Concentration.Cancers · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 11 institutions in 1 country.
Funding
Abstract
backgroundOral fluoropyrimidine plus cisplatin is often not tolerated by patients with severe peritoneal metastases of gastric cancer. Combination of 5-fluorouracil (5-FU), l-leucovorin (l-LV), and paclitaxel (FLTAX) has promising activity for such patients. We conducted a phase II/III study comparing FLTAX with 5-FU/l-LV.
methodsEligibility criteria included: unresectable or recurrent gastric adenocarcinoma; 20-75 years; performance status (PS) 0-2; peritoneal metastases + ; massive ascites and/or inadequate oral intake; no prior chemotherapy. Patients were randomly assigned to receive 5-FU/l-LV or FLTAX. The primary endpoint of phase III was overall survival: UMIN000010949.
resultsWe enrolled 101 patients. Early deaths occurred in patients with PS 2 having massive ascites and inadequate oral intake simultaneously; the protocol was amended to exclude such patients. Median survival times were 6.1 and 7.3 months for the 5-FU/l-LV and the FLTAX arms, respectively (HR 0.792; 80% CI 0.596-1.053; one-sided p = 0.1445). FLTAX arm had longer progression-free survival (PFS) [1.9 vs 5.4 months (HR 0.64; 95% CI, 0.43-0.96; p = 0.029)]. Grade 3/4 adverse events such as leucopenia and anorexia were more frequently observed in the 5-FU/l-LV arm. In the 5-FU/l-LV arm, two deaths were treatment-related. In the 5-FU/l-LV and FLTAX arms, 12 and 3 deaths occurred within 30 days after the last protocol treatment, respectively.
conclusionsChemotherapy was indicated for patients with severe peritoneal metastases excluding patients with PS 2 having massive ascites and inadequate oral intake simultaneously. FLTAX did not confer a significant survival benefit but may be preferred because of longer PFS and acceptable toxicity.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.