UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Ichiro Takemasa
Organization	Sapporo Medical University School of Medicine
Division name	Department of Surgery, Surgical Oncology and Science
Address	S1W16, Chuo-ku, Sapporo, Japan
TEL	0116112111
Email	itakemasa@sapmed.ac.jp

Public contact
Name of contact person	Kenji Okita
Organization	Sapporo Medical University School of Medicine
Division name	Department of Surgery, Surgical Oncology and Science
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 03 Month 30 Day
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

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Publication of results	Unpublished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