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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000016439
Receipt No. 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 2019/11/22

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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 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
Scientific Title:Acronym The E-Rechallenge Trial
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 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:
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)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 50

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
Institute Public Health Research Foundation
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
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 Main results already published
Date of protocol fixation
2014 Year 05 Month 20 Day
Date of IRB
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
2019 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019091


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