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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000008543
Receipt No. R000010043
Official scientific title of the study A Randomized, Multicenter, Phase III Study to Compare 6 Months of either 5-Fluorouracil / l-leucovorin plus Oxaliplatin (mFOLFOX6) or Capecitabine plus Oxaliplatin (XELOX) with 3 Months of either mFOLFOX6 or XELOX as Adjuvant Chemotherapy in Patients with Completely Resected Stage III Colon Cancer
Date of disclosure of the study information 2012/08/01
Last modified on 2015/03/18

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Basic information
Official scientific title of the study A Randomized, Multicenter, Phase III Study to Compare 6 Months of either 5-Fluorouracil / l-leucovorin plus Oxaliplatin (mFOLFOX6) or Capecitabine plus Oxaliplatin (XELOX) with 3 Months of either mFOLFOX6 or XELOX as Adjuvant Chemotherapy in Patients with Completely Resected Stage III Colon Cancer
Title of the study (Brief title) Adjuvant Chemotherapy for colon cancer with HIgh EVidencE
(JFMC47-1202-C3: ACHIEVE Trial)
Region
Japan

Condition
Condition stage III colon cancer (including rectosigmoid 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 evaluate the non-inferiority of treatment with mFOLFOX6/XELOX for 3 months as adjuvant chemotherapy versus 6 months of mFOLFOX6/ XELOX in terms of disease-free survival by IDEA pooled analysis for curatively resected stage III colon cancer (including rectosigmoid cancer).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Disease-free survival*1
*1: DFS is defined as relapse or death by IDEA.
Key secondary outcomes (1) Disease-free survival*2
*2: DFS is defined as relapse, second cancer or death.
(2) Time to treatment failure
(3) Overall survival
(4) Adverse events
(5) Completion rate
(6) Relative dose intensity
(7) Peripheral neuropathy
(8) Lymph node metastasis, lymph node dissection, lymph nodes examined, and prognosis
(9) Exploration of prognostic indicators and adverse events
(Additional study: Pharmacogenomics).

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Standard Arm (six months)

(1)mFOLFOX6 (12 courses)
L-OHP 85mg/m2
l-LV 200mg/m2
5-FU 400mg/m2 (bolus)
5-FU 2400mg/m2 (infusion)
every 2weeks

(2)XELOX (8 courses)
Oxaliplatin 130mg/m2 day1
Capacitabine 2000 or 1500mg/m2 day1 - 15(bid)
every 3 weeks
Interventions/Control_2 Test Arm (three months)

(1)mFOLFOX6 (6 courses)
L-OHP 85mg/m2
l-LV 200mg/m2
5-FU 400mg/m2 (bolus)
5-FU 2400mg/m2 (infusion)
every 2weeks

(2)XELOX (4 courses)
Oxaliplatin 130mg/m2 day1
Capacitabine 2000 or 1500mg/m2 day1 - 15(bid)
every 3 weeks
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) Histologically confirmed adenocarcinoma of the colon.
(2) Predominantly located in the cecum, colon, or rectosigmoid region based on the findings from surgery and/or surgical specimen.
(3) D2 or D3 lymph nodes resection.
(4) Curability A surgery (no residual tumor visible to macroscopically and/or microscopically).
(5) Stage III (T any N1/2/3 M0) (cf. The Japanese Classification of Colorectal Carcinoma, 7th edition, revised version).
(6) Registration within 8 weeks after resection and chemotherapy starting within 2 weeks after registration.
(7) Age >= 20 years.
(8) ECOG performance status of 0-1.
(9) Body surface area (DuBois) <=2.2 m2.
(10) No prior chemotherapy, immunotherapy, or radiation therapy.
(11) Adequate organ function:
i) neutrophil count >=1,500/mm3
ii) platelet count >=100,000/mm3
iii) serum creatinine <=1.5 times the ULN
iv) CCr >=30mL/min
v) total bilirubin <=2.0 mg/dL
vi) AST and ALT <=100 IU/L
vii) CEA <=10 ng/mL
(12) Written informed consent.
Key exclusion criteria (1) Cancer of the appendix.
(2) Past history of malignancy. (When there is the unrecurred period of 5 or more years, the intramucosal carcinoma [stomach cancer, colorectal cancer, esophagus cancer] by which recovery excision was performed endoscopically, the uterine cervical cancer, the basal cell carcinoma of the skin, and squamous cell carcinoma of the skin by which curative excision was performed can be enrolled.)
(3) Women who are pregnant or breast-feeding.
(4) Women who may become pregnant and fertile men.
(5) Participation in another clinical trial within 30 days before registration.
(6) Existing grade 1 or more peripheral sensory neuropathy.
(7) Uncontrolled diabetes mellitus (including insulin therapy).
(8) Uncontrolled congestive heart failure, angina pectoris, hypertension, and/or arrhythmia.
(9) Continuous systemic steroid therapy (oral or intravenous administration).
(10) A history and/or current evidence of significant neurological and/or mental illness.
(11) Active infectious disease (including known active hepatitis B virus infection, hepatitis C virus infection and human immunodeficiency virus).
(12) Known dihydropyrimidine dehydrogenase (DPD) deficiency.
(13) A history of allergy to 5-FU, l-LV, oxaliplatin, and/or capecitabine.
(14) Prior chemotherapy including oxaliplatin.
(15) Other reasons for being unfit for the study as determined by the attending physician.
Target sample size 1200

Research contact person
Name of lead principal investigator Masaki Mori (1),Atsushi Ohtsu (2),Takayuki Yoshino (3)
Organization Osaka University Graduate School of Medicine(1),National Cancer Center Hospital East(2),(3)
Division name Department of Gastroenterological Surgery(1),Research Center for Innovative Oncology(2),Department of Gastrointestinal Oncology(3)
Address 2-2-E2 Yamadaoka, Suita, Osaka 565-0871 Japan(1),6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan(2),(3)
TEL
Email

Public contact
Name of contact person Japanese Foundation for Multidisciplinary Treatment of Cancer
Organization Japanese Foundation for Multidisciplinary Treatment of Cancer
Division name Office
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

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

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
2012 Year 08 Month 01 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2012 Year 04 Month 19 Day
Anticipated trial start date
2012 Year 08 Month 01 Day
Last follow-up date
2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2012 Year 07 Month 26 Day
Last modified on
2015 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010043

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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