UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012856 |
|---|---|
| Receipt number | R000015024 |
| Scientific Title | A Phase II trial of SOX plus bevacizumab or cetuximab as neoadjuvant chemotherapy in patients with locally advanced rectal cancer (OITA-trial II) |
| Date of disclosure of the study information | 2014/01/15 |
| Last modified on | 2019/03/16 13:16:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Phase II trial of SOX plus bevacizumab or cetuximab as neoadjuvant chemotherapy in patients with locally advanced rectal cancer (OITA-trial II)
Acronym
OITA-trial II
Scientific Title
A Phase II trial of SOX plus bevacizumab or cetuximab as neoadjuvant chemotherapy in patients with locally advanced rectal cancer (OITA-trial II)
Scientific Title:Acronym
OITA-trial II
Region
| Japan |
Condition
Condition
locally advanced rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of SOX+bevacizumab or SOX+cetuximab as neoadjuvant chemotherapy in patients with locally advanced rectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
R0 resection rate
Key secondary outcomes
DFS, OS, Response rate, pathological Response, Safety, Rate of complete treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
S-1 80 mg/m2 p.o. (day1-14)
L-OHP 130 mg/m2(day 1)
[ KRAS-MT ]
bevacizumab 7.5mg/kg(day 1)
to be repeated every 3 week until 3 course or to meet discontinuation criteria
Interventions/Control_2
S-1 80 mg/m2 p.o. (day1-14)
L-OHP 130 mg/m2(day 1)
[ KRAS-WT ]
cetuximab 250mg/m2 (day 1, 8, 15)
to be repeated every 3 week until 3 course or to meet discontinuation criteria
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) Histologically confirmed rectal cancer (Ra, Rb, P)
2) Histologically confirmed adenocarcinoma
3) Clinical stage T3-4, N0-2(UICC 7th edition)
4) Age of 20 to 80 years old
5) PS(ECOG) 0-1
6) Confirmed KRAS status
7) Previously untreated rectal cancer (including chemotherapy, radiotherapy, hormonal therapy, or surgery)
8) be able to take oral drugs
9) Required baseline laboratory parameters (within 14 days before registration):
WBC >= 3000 ,< 12000/mm3
Neu >= 1,500/mm3
Plt >= 100,000/mm3
Hb >= 9.0g/dl
T-Bil <= 2.0mg/dl
AST,ALT <= 100U/L
Cre <1.5mg/dl
Ccr >= 60mL/min
10) Appropriate for the study at the physician's assessment
11) Written informed consent
Key exclusion criteria
1) History of serious drug hypersensitivity or a history of drug allergy
2) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 5 years or less)
3) Patients with contraindication to each drugs
4) Serious complication ( ex. intestinal paralysis, ileus, interstitial pneumonitis, pulmonary fibrosis, serious diabetes, serious hypertension cardiac failure, renal failure, or liver failure)
5) Previous history of serious lung disorder ( ex. interstitial lung disease or fibrosis, serious emphysema )
6) Pleural effusion, peritoneal fluid that needs treatment
7) Positive for HBs antigen
8) Patients who have bleeding from GI tract, intestinal paralysis, intestinal obstruction, peptic ulcer
9) Patients who need flucytosine, phenytoin or warfarin potassium.
10) History of thromboembolism, cerebral infarction or pulmonary infarction
11) Hemorrhagic diathesis, coagulation disorder
12) Requiring anti-thrombogenic therapy to prevent thrombosis
13) History of hemoptysis
14) Requiring consecutive systemic administration of steroid drug
15) Pregnant or lactating woman
16) Man who hope for Partner's pregnant
17) High-grade stricture
18) Not appropriate for the study at the physician's assessment
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masafumi INOMATA |
Organization
Oita University faculty of medicine
Division name
Department of Gastroenterological and Pediatric Surgery
Zip code
Address
1-1, Idaigaoka, Hazamacho, Yufushi, Oita 879-5593, Japan
TEL
097-586-5843
geka1@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masafumi INOMATA |
Organization
Oita University faculty of medicine
Division name
Department of Gastroenterological and Pediatric Surgery
Zip code
Address
1-1, Idaigaoka, Hazamacho, Yufushi, Oita 879-5593, Japan
TEL
097-586-5843
Homepage URL
geka1@oita-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological and Pediatric Surgery, Oita University faculty of medicine
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
大分大学医学部消化器・小児外科学講座、大分大学医学部腫瘍内科、大分医療センター 外科、大分県立病院 外科、大分赤十字病院 外科、健康保険南海病院 外科、中津市民病院 外科、別府医療センター 外科、有田胃腸病院 外科、大分岡病院 外科、大分東部病院 外科、膳所病院 外科、大分県厚生連鶴見病院、九州大学病院別府病院 外科、中津胃腸病院 外科、臼杵市医師会立コスモス病院 外科、津久見中央病院 外科、豊後大野市民病院 外科
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 15 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2013 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 28 | 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 | 15 | Day |
Last modified on
| 2019 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015024
