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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000013036
Receipt No. R000015216
Scientific Title 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 high-risk Stage II Colon Cancer
Date of disclosure of the study information 2014/01/31
Last modified on 2018/02/23

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Basic information
Public title 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 high-risk Stage II Colon Cancer
Acronym Adjuvant Chemotherapy for colon cancer with HIgh EVidencE in high-risk stage II
(JFMC48-1301-C4: ACHIEVE-2 Trial)
Scientific Title 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 high-risk Stage II Colon Cancer
Scientific Title:Acronym Adjuvant Chemotherapy for colon cancer with HIgh EVidencE in high-risk stage II
(JFMC48-1301-C4: ACHIEVE-2 Trial)
Region
Japan

Condition
Condition high-risk stage II 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 NO

Objectives
Narrative objectives1 To investigate the non-inferiority of treatment with modified FOLFOX6 or XELOX for 3 months as adjuvant chemotherapy to 6 months of mFOLFOX6/ XELOX in terms of disease-free survival by IDEA pooled analysis for curatively resected high-risk stage II 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*.
*DFS1 is defined as relapse or death by IDEA
Key secondary outcomes (1) Disease-free survival 2*.
*DFS2 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) Relationship between risk factors for recurrence and prognosis
(8) Follow-up of peripheral sensory neuropathy and palmar-plantar erythrodysesthesia syndrome

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)
L-OHP 130mg/m2 day1
Capacitabine 2000 or 1500*mg/m2 day1 - 15(bid)
every 3 weeks
*For patients with CCr<=50mL/min or age >=70
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)
L-OHP 130mg/m2 day1
Capacitabine 2000 or 1500*mg/m2 day1 - 15(bid)
every 3 weeks
*For patients with CCr<=50mL/min or age>= 70
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 II (SS/A/SE/SI/AI, N0, M0) (cf. The Japanese Classification of Colorectal Carcinoma, 7th edition, revised version) with at least one of the following risk factors for recurrence.
a) T4(SE/SI/AI)
b) bowel obstruction
c) bowel perforation/ penetration
d) less than 12 lymph nodes examined
e) poorly differentiated adenocarcinoma, signet ring cell adenocarcinoma or mucinous adenocarcinoma
f) vascular or lymphatic invasion (ly or v)
(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:
1) neutrophil count >=1,500/mm3
2) platelet count >=100,000/mm3
3) serum creatinine <=1.5 times the ULN
4) CCr >=30mL/min
5) total bilirubin <=2.0 mg/dL
6) AST and ALT <=100 IU/L
7) 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 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiko Maehara(1), Atsushi Ohtsu (2),Takayuki Yoshino (3)
Organization Graduate School of Medical Sciences
Kyushu University (1),
National Cancer Center Hospital East(2),(3)
Division name Department of Surgery and Science(1),Department of Gastrointestinal Oncology(3)
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka City, FUKUOKA, 812-8585, Japan (1), 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan(2), (3)
TEL 092-642-5461(1)04-7133-1111(2)(3)
Email jfmc48@jfmc.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Japanese Foundation for Multidisciplinary Treatment of Cancer
Organization Japanese Foundation for Multidisciplinary Treatment of Cancer
Division name Office
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2014 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2013 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 12 Day
Last follow-up date
2024 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 01 Month 31 Day
Last modified on
2018 Year 02 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015216

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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