Trial reportInternational journal of clinical oncology2017
A phase II study of 5-fluorouracil/L-leucovorin/oxaliplatin (mFOLFOX6) in Japanese patients with metastatic or unresectable small bowel adenocarcinoma.
Trial report in International journal of clinical oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 2 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
28 citing papers in PubMed, 2 syntheses or guidelines pooled it, 45 citations in OpenAlex.
- Evaluation of Systemic Treatments of Small Intestinal Adenocarcinomas: A Systematic Review and Meta-analysis.JAMA network open · 2023Pooled it
- Chemotherapy for patients with unresectable or metastatic small bowel adenocarcinoma: a systematic review.International journal of clinical oncology · 2020Pooled it
- ENVELOPE: enfortumab vedotin in patients with advanced small bowel adenocarcinoma refractory or intolerant to platinum-based therapy-phase II investigator-initiated trial (NCCH2412/MK015).ESMO gastrointestinal oncology · 2026Article
- Survival benefit of adjuvant chemotherapy for duodenal adenocarcinoma: a retrospective cohort study and propensity score-matched analysis.Translational cancer research · 2025Article
- Descending duodenal adenocarcinoma treated with pembrolizumab resulting in complete clinical response: A case report and literature review.World journal of gastrointestinal oncology · 2025Article
- Molecularly redefining small bowel adenocarcinoma to accelerate precision patient care - protocol of a multicenter observational cohort biomarker study.BMC cancer · 2025Article
- Article
- Outcomes of Metastatic and Unresectable Small Bowel Adenocarcinoma in Japan According to the Treatment Strategy: A Nationwide Observational Study.JCO global oncology · 2024Observational
- Efficacy of lymph node dissection for duodenal cancer according to the lymph node station.Annals of gastroenterological surgery · 2024Article
- Bibliometrics analysis on the research status and trends of small bowel adenocarcinoma: 1923-2023.Frontiers in oncology · 2024Review
- S-1 as an alternative treatment after 5-fluorouracil-induced coronary vasospasm in a patient with small bowel adenocarcinoma: a case report.International cancer conference journal · 2024Article
- An autopsy case of alpha-fetoprotein-producing large duodenal adenocarcinoma.Clinical journal of gastroenterology · 2023Article
- Characteristics and outcome of patients with small bowel adenocarcinoma (SBA).Journal of cancer research and clinical oncology · 2023Article
- Progress in the Treatment of Small Intestine Cancer.Current treatment options in oncology · 2023Review
- Review
- Article
- Review
- Therapeutic Strategies for Patients with Advanced Small Bowel Adenocarcinoma: Current Knowledge and Perspectives.Cancers · 2022Review
- Small Bowel Adenocarcinoma: From Molecular Insights to Clinical Management.Current oncology (Toronto, Ont.) · 2022Review
- Article
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 13 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSeveral studies have suggested that chemotherapy prolonged survival in patients with metastatic or recurrent small bowel adenocarcinoma (SBA); however, there is still no standard chemotherapy regimen. Here, we evaluated the efficacy and safety of a 5-fluorouracil (5-FU)/L-leucovorin (l-LV)/oxaliplatin (mFOLFOX6) protocol as a first-line therapy for patients with SBA. PATIENTS AND
methodsThis was a multicenter, single-arm, open-label phase II study. Eligibility criteria included histologically confirmed adenocarcinoma, age 20-80 years, and an Eastern Cooperative Oncology Group performance status (PS) of 0-2. The primary endpoint was 1-year progression-free survival (PFS). The secondary endpoints included overall response rate (ORR), overall survival (OS), overall PFS, and safety.
resultsBetween April 2010 and November 2012, 24 patients were enrolled from 12 institutions. The median age of the patients was 63 years (range 31-79) and there was a male/female ratio of 18/6. The number of PS 0/1 patients was 17/7 and locally advanced/metastatic disease was seen in 2/22 patients, respectively. The primary tumor site was the duodenum in 14 patients (58%) and jejunum in 10 patients (42%). The median follow-up time was 14.7 months (3.7-40.3). The 1-year PFS was 23.3%. The ORR was 9/20 (45%). The median PFS and OS times were 5.9 months (95% confidence interval [CI] 3.0-10.2) and 17.3 months (95% CI 11.7-19.0), respectively. Major grade 3/4 toxicities were neutropenia (38%), anemia/peripheral neuropathy (25%), and stenosis (17%). There were no treatment-related deaths.
conclusionsAlthough the primary endpoint was not met, mFOLFOX6 showed effective and good tolerance as a first-line treatment for SBA.
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Registered trials
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.