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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032784
Receipt No. R000037378
Scientific Title Phase I/II study of preoperative treatment with XELOXIRI(CPT-11, L-OHP, capecitabine) with Cetuximab in patients with RAS wild type-advanced colorectal cancer
Date of disclosure of the study information 2018/05/30
Last modified on 2018/05/30

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Basic information
Public title Phase I/II study of preoperative treatment with XELOXIRI(CPT-11, L-OHP, capecitabine) with Cetuximab
in patients with RAS wild type-advanced colorectal cancer
Acronym NAC XELOXIRI+Cetuximab in patients with advanced colorectal cancer
Scientific Title Phase I/II study of preoperative treatment with XELOXIRI(CPT-11, L-OHP, capecitabine) with Cetuximab
in patients with RAS wild type-advanced colorectal cancer
Scientific Title:Acronym NAC XELOXIRI+Cetuximab in patients with advanced colorectal cancer
Region
Japan

Condition
Condition locally advanced rectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of Cetuximab with capecitabine, oxaliplatin and irinotecan in patients with advanced rectal cancer as neoadjuvant setting
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes 1) Phase I
To determine the recommended dose
2) Phase II
pathological complete response rate
Key secondary outcomes 3 year disease free survival
3 year local recurrence rate
R0 resection rate
Safety
Pathological effect

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
Interventions/Control_1 Neo-adjuvant chemotherapy : XELOXIRI with Cetuximab 4 cycles
Resection : total mesorectal excision or tumor-specific mesorectal excision
Adjuvant chemotherapy : XELOX 4 cycles
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) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
2) Histological confirmation of colorectal cancer.
3) Main lesion of the tumor is located at the Ra or Rb.
4) Lower edge of the tumor is within 12cm from anal verge.
5) Clinical stage T3 or T4, and/or lymph node positive.
6) RAS wild status
7) UGT1A1 *28 and *6 with wild type or heterotypes
8) Vital organ functions listed below are preserved within 2 weeks prior to entry.
1. WBC 4,000 /mm3 and over
2. Hemoglobin 9.0 g/dl and over
3. Platelet 100,000 /mm3 and over
4. Total bilirubin 1.5 ml/dl and less
6. AST and ALT 150 IU/l and less
7. Creatinine 1.5 mg/dl and less
Key exclusion criteria 1) Any major surgical treatments within 4 weeks.
2) Prior chemotherapy or radiotherapy.
3) Pulmonary fibrosis or interstitial pneumonia.
4) Watery stool or diarrhea.
5) Active infection and inflammation or HBs antigen positive.
6) uncontrollable heart failure, renal failure, peptic ulcer, intestinal paralysis, ileus and diabetes mellitus.
7) synchronous or metachronous (within 3 years) malignancy other than carcinoma in situ
8) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. Men with no intention to practice birth control.
9) Severe mental disease.
10) History of the severe hypersensitivity.
11) Patients homozygous for UGT1A1*28, or UGT1A1*6, or heterozygous for both UGT1A1*28 and UGT1A1*6.
12) CTCAE v4.0>Grade1 of peripheral neuropathy.
13) Inadequate physical condition, as diagnosed by primary physician.
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ichiro Takemasa
Organization Sapporo Medical University School of Medicine
Division name Department of Surgery, Surgical Oncology and Science
Zip code
Address S1W16, Chuo-ku, Sapporo, Japan
TEL 0116112111
Email itakemasa@sapmed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Okita
Organization Sapporo Medical University School of Medicine
Division name Department of Surgery, Surgical Oncology and Science
Zip code
Address S1W16, Chuo-ku, Sapporo, Japan
TEL 0116112111
Homepage URL
Email okita@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University School of Medicine Department of Surgery, Surgical Oncology and Science
Institute
Department

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
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
2018 Year 05 Month 30 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 Open public recruiting
Date of protocol fixation
2018 Year 03 Month 30 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 01 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
2018 Year 05 Month 30 Day
Last modified on
2018 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037378

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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