UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024528 |
|---|---|
| Receipt number | R000028208 |
| 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) |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2022/09/25 22:30:06 |
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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
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
terasawat@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028208
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