UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027540 |
|---|---|
| Receipt number | R000031462 |
| Scientific Title | Analysis of FLT-PET imaging as a predictor of hematologic toxicity of chemotherapy in patients with lung cancer |
| Date of disclosure of the study information | 2017/05/31 |
| Last modified on | 2020/06/03 10:33:06 |
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Basic information
Public title
Analysis of FLT-PET imaging as a predictor of hematologic toxicity of chemotherapy in patients with lung cancer
Acronym
FLT-PET imaging as a predictor of hematologic toxicity
Scientific Title
Analysis of FLT-PET imaging as a predictor of hematologic toxicity of chemotherapy in patients with lung cancer
Scientific Title:Acronym
FLT-PET imaging as a predictor of hematologic toxicity
Region
| Japan |
Condition
Condition
Primary lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Tools are lacking to assess the individual risk of severe hematologic toxicity from chemotherapy.
This study is performed to clarify the prognostic value of FLT-PET imaging for severe hematologic toxicity in patients who recieve systemic chemotherapy for advanced lung cancer.
Basic objectives2
Others
Basic objectives -Others
To evaluate diagnostic relevancy of FLT-PET/MRI imaging.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between FLT uptake of the vertebral body and severe hematologic toxities during platinum doublet chemotherapy.
Key secondary outcomes
1, Relationship between FLT uptake of the vertebral body and severe non-hematologic toxities during platinum doublet chemotherapy.
2, Relationship between FLT uptake of the vertebral body and progression-free survival and overall survival.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
All patients undergo FLT-PET/MRI before initiation of systemic chemotherapy.
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) Patients with previously untreated advanced lung cancer
2) Patients who have indication of platinum-based doublet chemotherapy
3) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
4) Written informed consent
Key exclusion criteria
1) Pregnant woman
2) Patients with metalic device in their body
3) Patients with claustrophobia
4) Other cases attending physician it is determined unsuitable for registration of the study
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Yukihiro |
| Middle name | |
| Last name | Umeda |
Organization
University of Fukui
Division name
Third department of internal medicine
Zip code
9101193
Address
23-3, Matsuokashimoaizuki, Eiheiji-cho, Fukui, Japan
TEL
0776-61-3111
umeda@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Yukihiro |
| Middle name | |
| Last name | Umeda |
Organization
University of Fukui
Division name
Third department of internal medicine
Zip code
9101193
Address
23-3, Matsuokashimoaizuki, Eiheiji-cho, Fukui, Japan
TEL
0776-61-3111
Homepage URL
umeda@u-fukui.ac.jp
Sponsor or person
Institute
Third department of internal medicine, Universtiy of Fukui
Institute
Department
Personal name
Funding Source
Organization
None
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
The Research Ethics Committee of University of Fukui
Address
23-3, Matsuokashimoaizuki, Eiheiji-cho, Fukui, Japan
Tel
0776-61-3111
chiken@ml.cii.u-fukui.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
| 2017 | Year | 05 | Month | 31 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s00330-019-06161-4
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00330-019-06161-4
Number of participants that the trial has enrolled
50
Results
Severe hematological toxicity (HT) (grade3/4) was observed in 40.0% of patients during the first cycle. The ROC curve analyses revealed that the TVP/BSA of L4 was the most discriminative parameter among PET parameters for the prediction of severe HT. Furthermore, the sensitivity, specificity, and accuracy of the TVP/BSA of L4 cut-off of 68.7 to predict grade 3/4 HT were 80.0%, 86.7%, and 84.0%, respectively.
Results date posted
| 2020 | Year | 06 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In this study, 50 patients (median age, 67.5) with newly diagnosed primary lung cancer underwent a pretreatment 18F-FLT PET scan. While 38 patients had non-small cell carcinoma, 12 had small cell carcinoma. We included 8 patients with stage IIA-IIIA in this study because they were judged as a contraindication of surgery or radiotherapy by the attending physician owing to the low pulmonary function. Furthermore, 6 patients had the ECOG-PS of 2.
Participant flow
Of 75 patients who underwent 18F-FLT PET scan, we subsequently excluded 6 because of the final diagnosis of benign lung diseases and 19 because they received treatments other than platinum-doublet chemotherapy (operation, molecular-targeted drugs, chemoradiotherapy, and single-agent chemotherapy). Thus, we enrolled 50 patients with newly diagnosed primary lung cancer in this study.
Adverse events
Not applicable
Outcome measures
Severe hematological toxicity (HT) (grade3/4) was observed in 40.0% of patients during the first cycle. The ROC curve analyses revealed that the TVP/BSA of L4 was the most discriminative parameter among PET parameters for the prediction of severe HT. The multivariate logistic regression analysis revealed the TVP/BSA of L4 (odds ratio [OR], 0.94; P = 0.0036) and the frequency of the grade 3/4 hematological toxicity in previous clinical trials (OR, 1.03; P = 0.023) were independent predictors. Furthermore, the sensitivity, specificity, and accuracy of the TVP/BSA of L4 cut-off of 68.7 to predict grade 3/4 HT were 80.0%, 86.7%, and 84.0%, respectively. A low TVP/BSA of L4 (<68.7) as a binary variable was a significant indicator of severe HT (OR, 26.0; P = 0.000026).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2010 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 30 | Day |
Last modified on
| 2020 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031462
