UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009366 |
|---|---|
| Receipt number | R000011006 |
| Scientific Title | An exploratory study to find predictive factors for adverse effects of pemetrexed in patients with lung cancer |
| Date of disclosure of the study information | 2012/11/20 |
| Last modified on | 2023/08/30 11:41:21 |
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Basic information
Public title
An exploratory study to find predictive factors for adverse effects of pemetrexed in patients with lung cancer
Acronym
Predictive factors for adverse effects of pemetrexed
Scientific Title
An exploratory study to find predictive factors for adverse effects of pemetrexed in patients with lung cancer
Scientific Title:Acronym
Predictive factors for adverse effects of pemetrexed
Region
| Japan |
Condition
Condition
non-squamous and non-small cell lung cancer, pleural mesothelioma
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To find biological or genetical predictive factors for adverse effects of pemetrexed in patients with lung cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Adverse effects during 2 cycles of pemetrexed including chemotherapy
Key secondary outcomes
Response rate by RECIST criteria
Progression free survival
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically or cytologically confirmed non-squamous and non-small cell lung cancer and malignant pleural mesothelioma
2) Stage IIIB without any indication for radiotherapy or Stage IV or recurrent disease after surgery or radiotherapy
3) Treated with pemetrexed including regimen
4) ECOG PS 0-1
5) 20 years old or older
6) With or without measurable lesion
7) Adequate organ function evaluated within 14 days before enrollment
8) Life expectancy more than 12 weeks
9) Written informed consent
Key exclusion criteria
1) Treated with concurrent radiotherapy
2) Inappropriate for administration of pemetrexed
a) a history of serious drug hypersensitivity
b) severe myelosuppression, renal or hepatic dysfunction
c) contraindicated for the use of pemetrexed
d) severe comorbid disease
e) administration of systemic antimicrobial agents
f) continuous drainage for pleural effusion, ascites or cardiac effusion
g) brain metastasis with any symptoms
h) administration of systemic steroid
i) pregnancy, lactation or intention to pregnancy
j) judged to have difficulty in participation in this study because of psychosis or neurologic disease
k) judged to be inadequate for this study by doctors
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Takeda |
Organization
National center for global health and medicine
Division name
Department of Respiratory Medicine
Zip code
162-8655
Address
1-21-1 Toyama Shinjyuku-ku, Tokyo
TEL
03-3202-7181
ytakeda@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Yuichiro |
| Middle name | |
| Last name | Takeda |
Organization
National center for global health and medicine
Division name
Department of Respiratory Medicine
Zip code
162-8655
Address
1-21-1 Toyama Shinjyuku-ku, Tokyo
TEL
03-3202-7181
Homepage URL
ytakeda@hosp.ncgm.go.jp
Sponsor or person
Institute
National center for global health and medicine
Institute
Department
Personal name
Funding Source
Organization
Foundation of National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Medical oncology, Funabashi Municipal Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for Clinical sciences, National Center for Global health and Medicine
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan
Tel
03-3202-7181
rinrijm@hosp.ncgm.go.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
国立国際医療研究センター病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 20 | Day |
Related information
URL releasing protocol
not applicable
Publication of results
Published
Result
URL related to results and publications
BMC Cancer. 2023 Aug 26;23(1):800. doi: 10.1186/s12885-023-11257-8.
Number of participants that the trial has enrolled
63
Results
Progression-free survival of Pemetrexed (PEM) was associated with six pivotal factors, including a newly identified BHMT (742 G>A). Hematological toxicities were related to five crucial factors, including MTHFR (677 C>T). Non-hematological toxicities were associated with four critical factors, including MTHFR (677 C>T) and SLC19A1 [IVS2 (4935) G>A]. At using PEM, the information on the folate and methionine cycle's SNPs helps evaluate toxicities and efficacy.
Results date posted
| 2020 | Year | 11 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Post operative adjuvant / 1st line / 2nd line and more were 4 / 51 / 16, respectively. Platinum combined PEM was 60. 0 / 1 / 2 of performance status were 30 / 38 / 3.
Participant flow
From October 2012 to December 2019, we conducted a prospective observational study. We evaluated the toxicities and response of PEM-containing chemotherapy from the start of premedication to the end of 2 cycles and progression free survival (PFS). For screening examinations,118 patients were the candidate. After that, 106 patients were treated with PEM-containing chemotherapy. The number of patients with malignant pleural mesothelioma was 8 and that with non-Sq NSCLC was 98. Among them, 4 of mesothelioma and 67 of non-Sq NSCLC examined SNPs.
Adverse events
Hematological toxicities (Hem) Grade 3 to 4 were 27 (38 %), and Non-Hem Grade 3 to 4 were 26 (36.6 %).
Outcome measures
Toxicities evaluation; All types of adverse events during 1st cycle of PEM containing regimens.
Efficacies evaluation; Response rate by RECIST. Progression-free survival, overall survival.
Multivariate analyses were performed on PEM -related toxicities and efficacies.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 10 | Month | 06 | Day |
Other
Other related information
An exploratory study to find biological or genetical predictive factors for adverse effects of pemetrexed in patients with non-squamous and non-small cell lung cancer. Now on submitting for publication.
Management information
Registered date
| 2012 | Year | 11 | Month | 19 | Day |
Last modified on
| 2023 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011006
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