UMIN-CTR Clinical Trial

Basic information
Public title	Biomarker study for patients with metastatic colorectal cancer treated with anti-angiogenic agent using liquid biopsy
Acronym	AAA-liquid
Scientific Title	Biomarker study for patients with metastatic colorectal cancer treated with anti-angiogenic agent using liquid biopsy
Scientific Title:Acronym	AAA-liquid
Region	Japan

Condition
Condition	Colorectal cancer
Classification by specialty	Hematology and clinical oncology Adult
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To verify whether the presence or absence of mutations in RAS, BRAF, PIC3CA, EGFR, etc. in liquid biopsy before second-line chemotherapy for unresectable colorectal cancer is useful for predicting the efficacy of chemotherapy and the prognosis of colorectal cancer.
Basic objectives2	Others
Basic objectives -Others	Searching for biomarkers to predict the efficacy of anticancer chemotherapy
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Association of RAS, BRAF, PIC3CA, and EGFR gene mutations in liquid biopsy with chemotherapy efficacy and prognosis of colorectal cancer
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Histologically diagnosed as colorectal cancer Having distant metastases, at least one of which is unresectable The longest axis of metastatic lesion is more than 2cm in diameter. First line chemotherapy for distant metastases has been completed Age between 20 and 80 years at the date of enrollment ECOG PS 0-1 Having measurable metastatic lesion. Oral intake is possible. Expected to survive for at least 3 months Preservation of major organ function with all of the following on examination within 2 weeks prior to enrollment White blood cell count: 3,500/mm3or higher Neutrophil count: 1,500/mm3 or higher Platelet count: 75,000/mm3 or higher Hemoglobin: 8.0g/dl or higher AST and ALT: Less than 2.5 times the upper limit of the institutional standard Total bilirubin: 1.5 mg/dl or less Creatinine: 1.5mg/dl or less Infection: No active infection suspected. Diarrhea, other non-hematological toxicity: less than Grade 1(Excluding hair loss, dysgeusia, hyperpigmentation, and symptoms associated with the primary disease) The patient's free written consent to participate in this study has been obtained after receiving sufficient explanation and understanding.
Key exclusion criteria	Having UGT1A1*6 homo, UGT1A1*28 homo, and UGT1A1*6*28 double hetero Contraindicated for anti-VEGF inhibitor. Previous treatment with irinotecan Previous treatment with ramucirumab or aflibercept History of severe drug hypersensitivity Pregnant women or women who may become pregnant. Men whose partners wish to become pregnant. Patients with serious complications (interstitial pneumonia or pulmonary fibrosis, renal failure, hepatic failure, uncontrolled diabetes mellitus, uncontrolled hypertension) Patients with pleural effusion or ascites requiring treatment Patients with peritoneal dissemination that is considered likely to cause intestinal obstruction. Active multiple cancers. Significant ECG abnormalities or clinically problematic heart disease (heart failure, myocardial infarction, angina pectoris, etc.) Having brain metastases. Patients with active multiple cancers with a disease-free interval of less than 5 years (cured basal cell carcinoma of the skin and cervical cancer, or gastric cancer, esophageal cancer, and colorectal pM cancer confirmed to be cured by endoscopic mucosal resection may be enrolled. FDG-PET scan is not necessary, but bone metastasis should not be detected. The physician in charge considers the patient unsuitable for participation in this study.
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Takeshi Middle name Last name Yamada
Organization	Nippon Medical School Hospital
Division name	Department of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery
Zip code	113-8603
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL	+81-3-3822-2131
Email	y-tak@nms.ac.jp

Public contact
Name of contact person	1st name Hiromichi Middle name Last name Sonoda
Organization	Nippon Medical School Hospital
Division name	Department of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery
Zip code	113-8603
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL	+81-3-3822-2131
Homepage URL
Email	hiromichi-sonoda@nms.ac.jp

Sponsor
Institute	Nippon Medical Scool
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethical Committee, Nippon Medical School
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo
Tel	+81-3-3822-2131
Email	hiromichi-sonoda@nms.ac.jp

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	2021 Year 04 Month 12 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	Enrolling by invitation
Date of protocol fixation	2021 Year 03 Month 26 Day
Date of IRB	2021 Year 03 Month 26 Day
Anticipated trial start date	2021 Year 07 Month 01 Day
Last follow-up date	2027 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Multicenter prospective observational study

Management information
Registered date	2021 Year 04 Month 11 Day
Last modified on	2022 Year 04 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050119