UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000058419
Receipt number	R000066796
Scientific Title	Analysis of Prognostic Factors in Surgical Resection After mFOLFOX6 Plus Bevacizumab or mFOLFOX6 Plus Panitumumab in Chemotherapy-Naive Patients with Unresectable Advanced or Recurrent Colorectal Cancer with Wild-Type RAS (KRAS/NRAS) Genes
Date of disclosure of the study information	2025/07/10
Last modified on	2026/07/29 10:36:00

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Basic information

Public title

Analysis of Prognostic Factors in Surgical Resection After mFOLFOX6 Plus Bevacizumab or mFOLFOX6 Plus Panitumumab in Chemotherapy-Naive Patients with Unresectable Advanced or Recurrent Colorectal Cancer with Wild-Type RAS (KRAS/NRAS) Genes

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

patients with chemotherapy-naive RAS, wild-type, unresectable metastatic colorectal cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

YES

Objectives

Narrative objectives1

To analyze prognostic factors in surgical resection after mFOLFOX6 plus bevacizumab or mFOLFOX6 plus panitumumab.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Overall survival (OS),progression-free survival (PFS),and recurrence-free survival (RFS) in the conversion surgery cohort
OS,PFS,and RFS in the conversion surgery cohort,stratified by liver-limited vs.non-liver-limited metastases
OS,PFS,and RFS in the conversion surgery cohort,stratified by tumor-associated gene mutations
OS and PFS in the entire study population
OS and PFS in the entire study population,stratified by liver-limited vs.non-liver-limited metastases
OS and PFS in the entire study population,stratified by tumor-associated gene mutations

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Patients who were enrolled in the PARADIGM trial at 197 domestic institutions between March 2015 and July 2017 and underwent conversion surgery after receiving mFOLFOX6 plus bevacizumab or mFOLFOX6 plus panitumumab (excluding cases that were not included in the efficacy analysis of the PARADIGM trial).

Key exclusion criteria

1. Patients deemed inappropriate for participation in this study by the principal investigator or researchers.
2. Patients who have expressed their wish not to participate in the study.

Target sample size

156

Research contact person

Name of lead principal investigator

1st name Eiji

Middle name

Last name Oki

Organization

Graduate School of Medical Sciences, Kyushu University

Division name

Department of Surgery and Science

Zip code

812-8582

Address

3-1-1 Maidashi, Higashi-ku Fukuoka

TEL

092-642-5466

Email

oki.eiji.857@m.kyushu-u.ac.jp

Public contact

Name of contact person

1st name Tetsuro

Middle name

Last name Kawazoe

Organization

Graduate School of Medical Sciences, Kyushu University

Division name

Department of Surgery and Science

Zip code

812-8582

Address

3-1-1 Maidashi, Higashi-ku Fukuoka

TEL

092-642-5466

Homepage URL

Email

kawazoe.tetsuro.857@m.kyushu-u.ac.jp

Sponsor or person

Institute

Kyushu University

Institute

Department

Personal name

Funding Source

Organization

Takeda Pharmaceutical Company Ltd, Tokyo, Japan

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Kyushu University Medical District Observation Research Ethics Review Committee

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582 JAPAN

Tel

092-642-6254

Email

ijkrinri@jimu.kyushu-u.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2025 Year 07 Month 10 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

No longer recruiting

Date of protocol fixation

2025 Year 04 Month 23 Day

Date of IRB

2025 Year 07 Month 09 Day

Anticipated trial start date

2025 Year 07 Month 14 Day

Last follow-up date

2025 Year 10 Month 31 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

None

Management information

Registered date

2025 Year 07 Month 10 Day

Last modified on

2026 Year 07 Month 29 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066796