UMIN-CTR Clinical Trial

Public title

The Efficacy and Feasibility Study of Neoadjuvant Chemotherapy without Radiotherapy for Locally Advanced Rectal Cancer (Est-Neo)

Acronym

The Efficacy and Feasibility Study of Neoadjuvant Chemotherapy without Radiotherapy for Locally Advanced Rectal Cancer

Scientific Title

The Efficacy and Feasibility Study of Neoadjuvant Chemotherapy without Radiotherapy for Locally Advanced Rectal Cancer (Est-Neo)

Scientific Title:Acronym

The Efficacy and Feasibility Study of Neoadjuvant Chemotherapy without Radiotherapy for Locally Advanced Rectal Cancer

Region

Japan

Condition

Rectal Cancer

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To assess the efficacy and feasibility of neoadjuvant mFOLFOX6+Cet/Bev for locally advanced rectal cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

R0 resection rate

Key secondary outcomes

DFS, RFS, OS, local recurrence rate, Incidence of (severe) adverse event, Incidence of postoperative morbidity, Incidence of sexual dysfunction (male only), Incidence of urinary and anal dysfunction, Clinical response, Relative dose intensity, Chemotherapy completion rate

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

1. In the case of KRAS wild-type, 6 courses of mFOLFOX6+cetuximab is performed, followed by TME.
2. In the case of KRAS mutant-type, 6 courses of mFOLFOX6+bevacitumab is performed, followed by TME.

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

80

years-old

>

Gender

Male and Female

Key inclusion criteria

# Histologically confirmed adenocarcinoma of the rectum.
# Main part of the tumor is located in rectum or anal canal.
# Distal border of the tumor is located at or below peritoneal reflection.
# cT3, N0, M0 or T1-3, N1, M0 disease as assessed by transrectal ultrasound, CT or MRI.
# KRAS status is known.
# ECOG PS 0-1.
# Patient Characteristics:
1. WBC >= 3,000/mm3
2. ANC >= 1,500/mm3
3. Platelet count >= 100,000/mm3
4. Hemoglobin >= 9.0g/dL
5. Total bilirubin <= 1.5*ULN
6. AST <= 5*ULN
7. ALT <= 5*ULN
8. ALP <= 5*ULN
9. Serum creatinine <= 1.5*ULN
# Informed consent is obtained.

Key exclusion criteria

# Distant metastases
# Cerebrovascular disease (CVD) with paralytic symptoms or prior CVD within one year.
# Symptomatic or actively treated cardiac disorders. Or prior cardiac disorder within one year.
# Cancerous fluid on diagnostic imaging.
# Prior chemotherapy or pelvic irradiation for malignancy.
# Other cancer diagnosis within the past 5 years (including colorectal cancer).
# Interstitial pneumonia or fibroid lung.
# Uncontrolled infection.
# Current symptoms of neuropathy, defined as >= grade 2 neurosensory or neuromotor toxicity.
# Ileus (cases with diverting stoma are eligible).
# Uncontrolled diarrhea.
# Pregnant, nursing or no intention to contraception.
# Contraindication for the administration of bevacitumab (In the cases of KRAS mutant-type)
# Those considered inappropriate for participation in this trial.

Target sample size

55

Name of lead principal investigator

1st name
Middle name
Last name	Yoshiharu Sakai, MD

Organization

Kyoto University Hospital

Division name

Gastro-intestinal Surgery

Zip code

Address

54 Shogoin-kawaharacho, Sakyo-ku, Kyoto, 606-8507, JAPAN

TEL

075-366-7595

Email

ysakai@kuhp.kyoto-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Suguru Hasegawa, MD

Organization

Kyoto University Hospital

Division name

Gastro-intestinal Surgery

Zip code

Address

54 Shogoin-kawaharacho, Sakyo-ku, Kyoto, 606-8507, JAPAN

TEL

075-366-7595

Homepage URL

Email

shase@kuhp.kyoto-u.ac.jp

Institute

Gastro-intestinal Sugery Division, Kyoto University Hospital

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

京都大学医学部附属病院（京都府）
京都桂病院（京都府）
大阪赤十字病院（大阪府）
京都医療センター（京都府）
天理よろづ相談所病院（奈良県）
田附興風会北野病院（京都府）
京都桂病院（京都府）
滋賀成人病センター（滋賀県）

Date of disclosure of the study information

2011

Year

06

Month

01

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

Enrolling by invitation

Date of protocol fixation

2011

Year

04

Month

14

Day

Date of IRB

Anticipated trial start date

2011

Year

07

Month

01

Day

Last follow-up date

2018

Year

12

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

05

Month

26

Day

Last modified on

2013

Year

11

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006680