UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000016439
Receipt number	R000019091
Scientific Title	Phase II Clinical Study Evaluating the Efficacy and Safety of Cetuximab Rechallenge in Patients with Wild-Type RAS, Unresectable, Progressive/Recurrent Colorectal Cancer Refractory to Fluoropyrimidines, Oxaliplatin, Irinotecan, Cetuximab and Bevacizumab: The E-Rechallenge Trial
Date of disclosure of the study information	2015/02/04
Last modified on	2024/01/16 16:23:50

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Basic information

Public title

Phase II Clinical Study Evaluating the Efficacy and Safety of Cetuximab Rechallenge in Patients with Wild-Type RAS, Unresectable, Progressive/Recurrent Colorectal Cancer Refractory to Fluoropyrimidines, Oxaliplatin, Irinotecan, Cetuximab and Bevacizumab: The E-Rechallenge Trial

Acronym

The E-Rechallenge Trial

Scientific Title

Scientific Title:Acronym

The E-Rechallenge Trial

Region

Japan

Condition

Colorectal cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

Basic objectives2

Others

Basic objectives -Others

Response rate (RR)
Progression-free survival (PFS)
Overall survival (OS)
Association between the anti-EGFR antibody-free interval (aEFI) and the response rate Safety (frequency and severity of adverse events)

Trial characteristics_1

Others

Trial characteristics_2

Developmental phase

Phase II

Assessment

Primary outcomes

Response rate (RR)

Key secondary outcomes

Progression-free survival (PFS)

Overall survival (OS)

Association between the anti-EGFR antibody-free interval (aEFI) and the response rate

Safety (frequency and severity of adverse events)

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

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

administration of Cetuximab

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)Patients with colorectal cancer histologically classified as adenocarcinoma.
2)Patients in whom tumor positivity for wild-type RAS has been confirmed.
3)Patients with incurable, unresectable, progressive/recurrent cancer.
4)Patients with a measurable lesion according to RECIST (version 1.1).
5)Patients who have not undergone thoracotomy, laparotomy, or radiation therapy within 4 weeks before the start of protocol treatment (except for procedures related to a stoma or CV port and irradiation limited to approximately one vertebral body).
6) Patients who have not received any anticancer treatment within 2 weeks before the start of protocol treatment.
7) Patients whose tumors have become refractory to treatment with fluoropyrimidines, oxaliplatin, irinotecan, cetuximab or bevacizumab (or who have become intolerant of these agents, except irinotecan and cetuximab).
8) Patients who achieved CR, PR, or SD persisting for >=6 months as the best effect of previous treatment with cetuximab.
9) Patients who have received treatment with 1 or 2 regimens not including anti-EGFR antibody agents after previous treatment with cetuximab.
10) Patients in whom there is an interval >=16 weeks between the last dose of cetuximab during previous treatment and the scheduled date of cetuximab rechallenge (the start of protocol treatment).
11) Patients aged >=20 years at the time of giving informed consent.
12) Patients with an ECOG performance status (PS) of 0-1.
13) Patients in whom laboratory tests performed within 14 days before enrollment (including testing on the day exactly two weeks before enrollment) show satisfactory function of the following major organs, except those who received blood transfusion or treatment with hematopoietic growth factors such as G-CSF within 14 days before testing.
14) Patients who are negative for HBsAg.
15) Patients who are expected to survive for >=3 months.
16) Patients who received a full explanation about this study and gave written consent

Key exclusion criteria

1) Patients with severe diarrhea (watery stools).
2) Patients with active infection (requiring treatment with intravenous antibiotics or antibacterial agents, antifungal agents, or antiviral agents) or with HIV infection.
3) Patients with fluid in a body cavity (such as a pleural effusion, ascites, or pericardial effusion) that requires treatment.
4) Patients with clinical evidence of coronary artery disease, myocardial infarction within 12 months before enrollment, or a poorly controlled arrhythmia or cardiac dysfunction.
5) Patients with pulmonary fibrosis, an acute lung disorder, or interstitial pneumonitis (or a history of any of these conditions).
6) Patients with intestinal paralysis or obstruction.
7) Patients with jaundice or hepatic failure.
8) Patients on treatment with atazanavir sulfate.
9) Patients with uncontrolled diabetes mellitus, malignant hypertension, or hypercalcemia.
10) Patients with symptomatic brain metastasis.
11) Patients with a history of hypersensitivity to cetuximab or irinotecan.
12) Patients with synchronous double cancer or with metachronous double cancer and a disease-free interval <=5 years (except for skin cancer and early gastrointestinal cancer likely to be cured by endoscopic mucosal resection).
13) Men who are unwilling to use contraception, and pregnant women, nursing mothers, women with positive pregnancy test, or women unwilling to use contraception.
14) Other patients who the investigator judges to be unsuitable as subjects of this study.

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Kensei Yamaguchi

Organization

Japanese Foundation for Cancer Research, Cancer Institute Hospital, Gastroenterology Center

Division name

Department of Gastroenterology

Zip code

Address

3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan

TEL

03-3520-0141

Email

kensei.yamaguchi@jfcr.or.jp

Public contact

Name of contact person

1st name

Middle name

Last name Eiji Shinozaki

Organization

Japanese Foundation for Cancer Research, Cancer Institute Hospital, Gastroenterology Center

Division name

Department of Gastroenterology

Zip code

Address

3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan

TEL

03-3520-0141

Homepage URL

Email

eiji.shinozaki@jfcr.or.jp

Sponsor or person

Institute

Public Health Research Foundation

Institute

Department

Personal name

Funding Source

Organization

Merck Serono Co., Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

Bristol-Myers Squibb

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

公益財団法人がん研究会有明病院
社会福祉法人仁生社江戸川病院
神奈川県立がんセンター
KKR札幌医療センター
社会医療法人財団慈泉会相澤病院
東京医科歯科大学医学部附属病院
社会医療法人明和会中通総合病院
がん・感染症センター都立駒込病院
佐賀県医療センター好生館
神戸市立医療センター中央市民病院
杏林大学医学部付属病院
山形県立中央病院

Other administrative information

Date of disclosure of the study information

2015 Year 02 Month 04 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

Completed

Date of protocol fixation

2014 Year 05 Month 20 Day

Date of IRB

2014 Year 10 Month 20 Day

Anticipated trial start date

2014 Year 12 Month 01 Day

Last follow-up date

2017 Year 12 Month 31 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2015 Year 02 Month 04 Day

Last modified on

2024 Year 01 Month 16 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019091

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name