UMIN-CTR Clinical Trial

Basic information
Public title	First-line single-agent Panitumumab in the Japanese frail patients with wild-type RAS unresectable colorectal cancer: A phase II study(OGSG 1602)
Acronym	First-line single-agent Panitumumab in the Japanese frail patients with wild-type RAS unerectable colorectal cancer: A phase II study(OGSG 1602)
Scientific Title	First-line single-agent Panitumumab in the Japanese frail patients with wild-type RAS unresectable colorectal cancer: A phase II study(OGSG 1602)
Scientific Title:Acronym	First-line single-agent Panitumumab in the Japanese frail patients with wild-type RAS unerectable colorectal cancer: A phase II study(OGSG 1602)
Region	Japan

Condition
Condition	colorectal cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of first-line single agent Panitumumab in the Japanese frail patients with wild-type RAS unresectable colorectal cancer whom the treating oncologist considered standard intensive chemotherapy to be unsuitable.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Disease control rate (DCR)
Key secondary outcomes	Response Rate (RR) Progression free survival (PFS) Overall survival (OS) Time to Treatment Failure (TTF) Safety : the rate of Grade3/4 toxicity

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Panitumumab 6mg/kg intravenously every 2 weeks
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Histologically confirmed CRC that is not a candidate for curative surgical resection 2) Wild Type RAS 3) Patients with metastatic colorectal cancer have received no previous systemic chemotherapy. 4) Age >= 76 years old or age >= 65 who were not deemed to be candidates for combination chemotherapy in the judgment of the treating investigator 5) Measurable disease according to the modified Response Evaluation Criteria In Solid Tumours (mRECIST) criteria (version 1.1) 6) Adequate organ function 7) Life expectancy of at least 90 days from enrollment 8) Written informed consent prior to study-specific screening procedure 9) Who had not received EGFR antibody
Key exclusion criteria	1) Uncontrolled diarrhea 2) Symptomatic Interstitial pneumonia or pulmonary fibrosis 3) Previous palliative radiation therapy for bone metastasis or brain metastasis within 2 weeks 4) History of other malignancy with a disease-free interval <1 years (other than curatively treated cutaneous basal cell carcinoma, curatively treated carcinoma in situ of the cervix, and gastroenterological cancer confirmed to be cured by endoscopic mucosal resection) 5) Active infections 6) Serious complications Uncontrolled diabetes mellitus, Uncontrolled gastrointestinal bleeding, Heart failure(and over NYHA ll), hepatic failure and so on 7) History of serious anaphylaxis 8) Requires continuous treatment with systtematic steroids 9) Psychiatric disability that would preclude study compliance 10)Pregnant or lactating females, and males and females unwilling to use contraception 11) HBs antigen positive 12) Otherwise determined by the investigator to be unsuitable for participation in the study
Target sample size	36

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masahiro Gotou
Organization	Osaka Medical College Hospital
Division name	Chemotherapy Center
Zip code
Address	2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
TEL	072-683-1211
Email	in2030@poh.osaka-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tetsuji Terazawa
Organization	Osaka Medical College Hospital
Division name	Chemotherapy Center
Zip code
Address	2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
TEL	072-683-1211
Homepage URL
Email	terasawat@poh.osaka-med.ac.jp

Sponsor
Institute	Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Institute
Department

Funding Source
Organization	Takeda Pharmaceutical Company Limited
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
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	大阪医科大学病院（大阪府）、大阪労災病院（大阪府）、市立東大阪医療センター（大阪府）、関西労災病院（兵庫県）、神戸市立医療センター中央市民病院（兵庫県）、兵庫県立西宮病院（兵庫県）、堺市立総合医療センター（大阪府）。大阪医療センター（大阪府）、関西電力病院（大阪府）、大阪府済生会千里病院（大阪府）、近畿大学（大阪府）、市立伊丹病院（大阪府）、耳原総合病院（大阪府）

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 01 Day

Related information
URL releasing protocol	https://bmccancer.biomedcentral.com/articles/10.1186/s12885-019-5821-z
Publication of results	Published

Result
URL related to results and publications	https://theoncologist.onlinelibrary.wiley.com/doi/10.1002/ONCO.13523
Number of participants that the trial has enrolled	36
Results	The response rate (RR) was 50.0% (95% confidence interval [CI], 32.4-67.6). A total of 26.5% had stable diseases, resulting in a disease control rate (DCR) of 76.5% (90% CI, 61.5-87.7). The RR of patients with left- and right-sided tumors was 65.4% (95% CI, 44.3-82.8) and 0.0% (95% CI, 0.0-36.9), respectively. The median progression-free survival (PFS) and overall survival (OS) were 6.0 [95% CI, 5.4-10.0] and 17.5 months (95% CI, 13.8-24.3), respectively.
Results date posted	2020 Year 11 Month 24 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 09 Month 12 Day
Baseline Characteristics	chemotherapy-naive frail or elderly patients with unresectable RAS wild-type (WT) colorectal cancer (CRC) Thirty-three (91.6%) patients had a performance status (PS) of 0 or 1, whereas two (5.6%) patients and one (2.8%) patient had a PS of 2 and 3, respectively. Twenty-eight patients (77.8%) had left-sided CRC, whereas eight (22.2%) had right-sided CRC.
Participant flow	Thirty-six patients (median age: 81 [range, 67-88] years) were enrolled between February 2017 and August 2018. Two patients were excluded from the analysis of efficacy: one from lack of image examination at baseline and the other from lack of a measurable lesion.
Adverse events	Major grade 3 or 4 nonhematologic toxicities were rash (n=6, 16.7%), hypomagnesemia (n=4, 11.1%), fatigue (n=3, 8.3%), paronychia (n=2, 5.6%), and hyponatremia (n=2, 5.6%). The only grade 3 hematologic toxicity was neutropenia (n=1, 2.8%).
Outcome measures	https://bmccancer.biomedcentral.com/articles/10.1186/s12885-019-5821-z The response rate (RR) was 50.0% (95% confidence interval [CI], 32.4-67.6), including three patients (8.8%) who had complete responses. A total of 26.5% had stable diseases, resulting in a disease control rate (DCR) of 76.5% (90% CI, 61.5-87.7). The RR of patients with left- and right-sided tumors was 65.4% (95% CI, 44.3-82.8) and 0.0% (95% CI, 0.0-36.9), respectively. https://academic.oup.com/oncolo/advance-article/doi/10.1093/oncolo/oyac145/6659959?login=false The median progression-free survival (PFS) and overall survival (OS) were 6.0 [95% CI, 5.4-10.0] and 17.5 months (95% CI, 13.8-24.3), respectively.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 09 Month 28 Day
Date of IRB	2016 Year 09 Month 27 Day
Anticipated trial start date	2017 Year 02 Month 09 Day
Last follow-up date	2020 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 01 Month 20 Day

Other
Other related information

Management information
Registered date	2016 Year 10 Month 23 Day
Last modified on	2022 Year 09 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028208