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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004443
Receipt No. R000005318
Scientific Title A tolerability study in Japan of Oxaliplatin, fluorouracil, and l-leucovorin for patients with stage II/III colon cancer
Date of disclosure of the study information 2010/11/01
Last modified on 2019/09/26

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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
Japan

Condition
Condition StageII/III colon cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To confirm tolerability Oxaliplatin, fluorouracil, and l-leucovorin for Japanese patients with stage II/III colon cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes The frequency of allergies, anaphylaxis, and peripheral sensory neuropathy lasting for 8 days (Grade 3 or 4).
Key secondary outcomes (1) Disease-free survival.
(2) Relapse-free survival.
(3) Time to treatment failure.
(4) Overall survival.
(5) Adverse events.
(6) Peripheral neuropathy.
(7) Completion rate.
(8) Relative dose intensity.
(9) Relationship between lymph node metastasis and prognosis.
(10) Exploration of predictors of the prognosis and adverse events (Additional study).

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Gene
Interventions/Control_1 L-OHP85mg/m2,l-LV200mg/m2, 5FU400mg/m2(bolus),and 5FU2400mg/m2(infusion)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
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

Research contact person
Name of lead principal investigator
1st name Takayuki
Middle name
Last name Yoshino
Organization National Cancer Center Hospital East
Division name Endoscopy & Gastrointestinal Oncology
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan
TEL 04-7133-1111
Email tyoshino@east.ncc.go.jp

Public contact
Name of contact person
1st name Yukari
Middle name
Last name Kawamura
Organization Japanese Foundation for Multidisciplinary Treatment of Cancer
Division name Office
Zip code 136-0071
Address 1-28-6 kameido, koutou-ku, Tokyo, 136-0071, Japan
TEL 03-5627-7594
Homepage URL http://www.jfmc.or.jp/
Email jfmc-dc@jfmc.or.jp

Sponsor
Institute Japanese Foundation for Multidisciplinary Treatment of Cancer
Institute
Department

Funding Source
Organization Yakult Honsha Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Japanese Foundation for Multidisciplinary Treatment of Cancer
Address 1-28-6 kameido, koutou-ku, Tokyo, 136-0071, Japan
Tel 03-5627-7594
Email jfmc-dc@jfmc.or.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 01 Day

Related information
URL releasing protocol http://www.jfmc.or.jp/
Publication of results Published

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
Results Delay Reason
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
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 10 Month 04 Day
Date of IRB
2010 Year 09 Month 09 Day
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
2015 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 10 Month 26 Day
Last modified on
2019 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005318

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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