| Basic information |
| Public title |
A tolerability study in Japan of Oxaliplatin, fluorouracil, and l-leucovorin for patients with stage II/III colon cancer |
| Acronym |
A tolerability study in Japan of OxaliplatIN, fluorouracil, and l-leucovorin for patients with stage II/III colon cancer(JFMC41-1001-C2: JOIN Trial) |
| Scientific Title |
A tolerability study in Japan of Oxaliplatin, fluorouracil, and l-leucovorin for patients with stage II/III colon cancer |
| Scientific Title:Acronym |
A tolerability study in Japan of OxaliplatIN, fluorouracil, and l-leucovorin for patients with stage II/III colon cancer(JFMC41-1001-C2: JOIN Trial) |
| Region |
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| Eligibility |
| Age-lower limit |
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| Age-upper limit |
|
| Gender |
Male and Female |
| Key inclusion criteria |
1) Stage II/Stage III, histologically confirmed colon cancer.
2) Curability A.
3) Chemotherapy starting within 7 weeks after resection and 2 weeks after registration.
4) Age of 20 years or older.
5) Performance status of 0-2.
6) No prior chemotherapy, immunotherapy, or radiation.
7) Adequate organ function:
i) neutrophil count >1,500 /mm3,
ii) platelet count >=100,000/mm3,
iii) serum creatinine <=1.25 times the ULN,
iv) total bilirubin <2 times the ULN,
v) AST, ALT <2 times the ULN, and
vi) CEA <10 ng/mL.
8) Pregnancy test: (-).
9) Women who will not become pregnant.
10) Written informed consent. |
| Key exclusion criteria |
1) Women who are pregnant or breast-feeding.
2) Women who are planning to become pregnant.
3) Appendix cancer.
4) Patients with a history of malignancy.
5) Participating in another clinical trial within 30 days.
6) Peripheral sensory neuropathy >= Grade 1.
7) Insulin-treated diabetic patients.
8) Uncontrolled congestive heart failure, angina pectoris, hypertension, and arrhythmia.
9) Patients with a history of significant neurological or mental illness.
10) Active infectious disease.
11) Other patients who are unfit for the study as determined by the attending physician. |
| Target sample size |
800 |
| Result |
| URL related to results and publications |
https://doi.org/10.1007/s00280-019-03957-5 |
| Number of participants that the trial has enrolled |
882 |
| Results |
The PSN for >=8 days and the incidence of Gr.>=3 AR were 3.3% and 1.7%, respectively. At the onset of PSN, the median total dose of L-OHP and the median number of courses were 672.5mg/m2 and 9, respectively, while the corresponding values were 565.1mg/m2 and 7.5 at the onset of Gr.>=3 AR. Gr.3PSN appeared to gradually recover from 5.8% to 1.1%, 0.5%, and 0.2% at 12mths, 24mths and 36mths after enrollment, respectively. However, Gr.1 or Gr.2 PSNs after 3yrs follow-up were observed in 21.0% of patients. |
| Results date posted |
| 2019 |
Year |
09 |
Month |
26 |
Day |
|
| Results Delayed |
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| Results Delay Reason |
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| Date of the first journal publication of results |
|
| Baseline Characteristics |
Baseline patient characteristics were as follows: median age, 64 years; male, 53.8%; PS 0, 93.8%; stage II/IIIA/IIIB/IIIC by TNM Classification, 7th edition, 18.5/7.3/52.5/21.6%; and lymph nodes examined, <12 / >12/ unknown: 17.2/82.5/0.2%, respectively. |
| Participant flow |
Between November 2010 and March 2012, 882 patients were enrolled at 198 institutions. Among these 882 patients, 11 were ineligible. Of the remaining 871 eligible patients, 864 patients (98%) for whom the treatment status was fixed with a median follow-up of 3 years as of October 30, 2015 via an electronic data capture system with central monitoring, were included in the efficacy analysis. Among these 871 eligible patients, 9 did not start the study treatment, and 14 did not receive the correct initial dosage at their physician's discretion. These 23 patients were excluded from the safety analysis by central monitoring. Of the remaining 848 patients, 828(94%) patients for whom the treatment status was fixed by April 30, 2013, were included in the safety analysis. |
| Adverse events |
The only grade >=3 AE occurring in more than 10 % of the patients was neutropenia, which was observed in 28.7 %. However, the incidence of febrile neutropenia was 0.4 %. There was only one case of grade 3 interstitial pneumonitis, and there were no treatment-related deaths. |
| Outcome measures |
Three-year DFS, RFS, and OS in the overall efficacy population were 76.1% (95%CI: 73.02 to 78.80), 77.3% (95% CI: 74.34 to 80.02), and 92.7% (95%CI: 90.69 to 94.26), respectively. Favorable 3-year DFS, RFS, and OS were 92.1, 92.8, and 97.4% in stage II patients, while these were 76.4, 77.9, and 93.8% in stage IIIA/B; and 61.6, 62.7, and 85.9% in stage IIIC, respectively. The main recurrent sites were liver (7.6%), lung (7.3%), and lymph nodes (5.2%). |
| Plan to share IPD |
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| IPD sharing Plan description |
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