Trial reportCancer chemotherapy and pharmacology2015
Initial safety report on the tolerability of modified FOLFOX6 as adjuvant therapy in patients with curatively resected stage II or III colon cancer (JFMC41-1001-C2: JOIN trial).
Trial report in Cancer chemotherapy and pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
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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.
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Who cites it
14 citing papers in PubMed, 28 citations in OpenAlex.
- Randomized phase II study of tegafur-uracil/leucovorin versus tegafur-uracil/leucovorin plus oxaliplatin after curative resection of high-risk stage II/III colorectal cancer (SOAC-1101 trial).International journal of colorectal disease · 2021Trial
- A placebo-controlled, double-blind, randomized study of recombinant thrombomodulin (ART-123) to prevent oxaliplatin-induced peripheral neuropathy.Cancer chemotherapy and pharmacology · 2020Trial
- Evaluation of FOLFOX or CAPOX reintroduction with or without bevacizumab in relapsed colorectal cancer patients treated with oxaliplatin as adjuvant chemotherapy (REACT study).International journal of clinical oncology · 2020Trial
- JOIN trial: treatment outcome and recovery status of peripheral sensory neuropathy during a 3-year follow-up in patients receiving modified FOLFOX6 as adjuvant treatment for stage II/III colon cancer.Cancer chemotherapy and pharmacology · 2019Trial
- Efficacy and Long-term Peripheral Sensory Neuropathy of 3 vs 6 Months of Oxaliplatin-Based Adjuvant Chemotherapy for Colon Cancer: The ACHIEVE Phase 3 Randomized Clinical Trial.JAMA oncology · 2019Trial
- Safety of mFOLFOX6/XELOX as adjuvant chemotherapy after curative resection of stage III colon cancer: phase II clinical study (The FACOS study).International journal of colorectal disease · 2018Trial
- Final report of KSCC0803: feasibility study of capecitabine as adjuvant chemotherapy for stage III colon cancer in Japan.International journal of clinical oncology · 2017Trial
- A pilot study on the safety and efficacy of neoadjuvant chemo‑adoptive immunotherapy for locally advanced rectal cancer.Oncology letters · 2024Article
- Prognostic Impact of Main Lymph Node Metastasis in Patients with Colon Cancer.World journal of surgery · 2023Article
- The updated five-year overall survival and long-term oxaliplatin-related neurotoxicity assessment of the FACOS study.Surgery today · 2021Article
- Optimal adjuvant chemotherapy completion time for stage III colon cancer: a cohort study.Journal of gastrointestinal oncology · 2021Article
- Oxaliplatin-Induced Lhermitte's Sign in Gastric Cancer.Case reports in oncological medicine · 2020Article
- Article
- Elevated tumor-to-liver uptake ratio (TLR) fromEuropean journal of nuclear medicine and molecular imaging · 2017Article
Corrections and comments
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Authors and funding
15 authors at 9 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeAdjuvant FOLFOX is a widely accepted standard therapy for resected colon cancer. The incidence of grade 3-4 peripheral sensory neuropathy (PSN) was 12.4 and 5.7 % in the MOSAIC and Eastern MASCOT trials, while that of grade 3-4 allergic reactions (AR) was 2.9 and 3.1 %, respectively. The JFMC41-1001-C2 trial (JOIN trial) investigated the tolerability of modified FOLFOX6 (mFOLFOX6) in Japanese colon cancer patients.
methodsTwelve cycles of mFOLFOX6 were given to patients with the same eligibility criteria as in the MOSAIC study: stage II or III curatively resected colon cancer, performance status of 0-1, aged 20 years or older, starting mFOLFOX6 within 7 weeks of surgery, and adequate organ function. The primary endpoints were the incidence of PSN persisting for ≥8 days that interfered with daily activities and the incidence of grade 3-4 AR. The target sample size was 800.
resultsFrom November 2010 to March 2012, 882 patients were enrolled at 198 institutions. Safety was analyzed in 828 patients with finalized data out of 848 patients receiving mFOLFOX6. The incidence of PSN persisting ≥8 days was 3.3 % [95 % confidence interval (CI) 2.2-4.7], while that of grade 3-4 AR was 1.7 % (95 % CI 0.9-2.8). The treatment completion rate was 67.0 %. The median total dosage of oxaliplatin was 811.1 mg/m(2). The overall incidence of grade 3-4 PSN was 5.8 %. Interstitial pneumonitis occurred in one patient. There were no treatment-related deaths.
conclusionsAdjuvant mFOLFOX6 is tolerable for Japanese patients with colon cancer.
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