UMIN-CTR Clinical Trial

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

locally advanced rectal cancer

Classification by specialty

Gastroenterology	Hematology and clinical oncology	Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

05

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2018

Year

05

Month

30

Day

Last modified on

2018

Year

05

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037378