UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012535 |
|---|---|
| Receipt number | R000013449 |
| Scientific Title | Multicenter phase II study of CapeOX (XELOX) with stop-and-go strategy as adjuvant chemotherapy in high-risk Stage II or Stage III colon and rectal cancer |
| Date of disclosure of the study information | 2013/12/09 |
| Last modified on | 2016/11/16 09:03:09 |
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Basic information
Public title
Multicenter phase II study of CapeOX (XELOX) with stop-and-go strategy as adjuvant chemotherapy in high-risk Stage II or Stage III colon and rectal cancer
Acronym
COACH Trial (CCOG 1302)
Scientific Title
Multicenter phase II study of CapeOX (XELOX) with stop-and-go strategy as adjuvant chemotherapy in high-risk Stage II or Stage III colon and rectal cancer
Scientific Title:Acronym
COACH Trial (CCOG 1302)
Region
| Japan |
Condition
Condition
High-risk Stage II or stage III colon and rectum cancer(above the peritoneal reflection)
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of CapeOX and CapeOX with Oxaliplatin Stop-and-Go Strategy in curatively resected High-risk Stage II / Stage III colon cancer(above the peritoneal reflection) as adjuvant chemotherapies
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The frequency of peripheral sensory neuropathy 12 months after the treatment
Key secondary outcomes
"Disease-free survival rate
Relaps-free survival rate
Overall survival rate
Oxaliplatin induced neuropathy rate
Relative dose intensity
Safety
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
CapeOX(XELOX) (8 courses)
Oxaliplatin 130mg/m2 day1
Capacitabine 2000mg/m2 day1 - 15(bid)
every 3 weeks
Interventions/Control_2
(1)Initial therapy(2 courses)
: CapeOX therapy
(2)Maintenance therapy(4 courses)
: Capecitabin therapy(omit the oxaliplatin)
(3)Reintroduced therapy(2 courses)
: CapeOX therapy
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Written informed consent
(2) D2 or D3 lymph nodes resection and Curability A surgery (no residual tumor visible to macroscopically and/or microscopically).
(3) Predominantly located in the cecum, colon, rectosigmoid region or rectum (above the peritoneal reflection) based on the findings from surgery and/or surgical specimen.
(4) Pathological Stage III or High risk Stage II
: High risk Stage II, defined as those with poor prognostic features, including
1) T4 tumors (UICC TNM 7th edition)
2) Bowel obstruction
3) Perforation
4) <12 lymph nodes examined
5) Poorly differentiated histology
6) Vascular or Lymphatic invasion
(5) Registration and chemotherapy starting within 8 weeks after resection.
(6) Age: 20-80 years
(7) Performance status (PS) 0-1
(8) A life expectancy greater than 3 months
(9) No prior chemotherapy, immunotherapy, or radiation therapy.
(10) Adequate organ function
Key exclusion criteria
(1)Appendix cancer or anal cancer
(2)Distal extent of tumor must be in the Rb
(3)Multiple malignacies to be treated
(4)Ileus, bowel obstruction or uncontrolled peptic ulcer.
(5)Uncontrolled severe complications(DM, hypertension, diarrhea, et al.)
(6)Massive pleural effusion or ascites that required drainage.
(7) Patient with symptomatic cardiovascular disease or asymptomatic disease but has been treated (>=Grade 2 according to NCI-CTCAE ver.4). History of myocardial infarction within a year.
(8) A history of allergy to 5-FU, platina, or Known dihydropyrimidine dehydrogenase (DPD) deficiency.
(9)Severe neuropathy
(10)With interstitial lung disease or pulmonary fibrosis
(11)Continuous systemic steroid therapy (oral or intravenous administration).
(12)A history and/or current evidence of significant neurological and/or mental illness.
(13)Pregnant
(14)Without intention to contraception
(15)Prior chemotherapy including Oxaliplatin or Capecitabin
(16)Not appropriate for the study at the physician's assessment.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Goro Nakayama |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya-city, Aichi, Japan
TEL
(81)52-744-2253
goro@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miyuki Aoki |
Organization
Chubu Clinical Oncology Group (CCOG)
Division name
Data Center
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya-city, Aichi, Japan
TEL
(81)52-744-2253
Homepage URL
http://www.med.nagoya-u.ac.jp/surgery2/scientific/ccog/
goro@med.nagoya-u.ac.jp
Sponsor or person
Institute
Chubu Clinical Oncology Group
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 12 | Month | 09 | 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 | 12 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 09 | Day |
Last modified on
| 2016 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013449
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