UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011733
Receipt number R000013173
Scientific Title New prognostic indexes for overall survival in malignant mesothelioma treated with pemetrexed or best supportive care in the real world
Date of disclosure of the study information 2013/09/12
Last modified on 2015/04/11 22:31:32

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Basic information

Public title

New prognostic indexes for overall survival in malignant mesothelioma treated with pemetrexed or best supportive care in the real world

Acronym

New prognostic indexes for overall survival in malignant mesothelioma

Scientific Title

New prognostic indexes for overall survival in malignant mesothelioma treated with pemetrexed or best supportive care in the real world

Scientific Title:Acronym

New prognostic indexes for overall survival in malignant mesothelioma

Region

Japan


Condition

Condition

malignant pleural mesothelioma

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To build prognostic indexes for the malignant pleural mesothelioma patients treated with pemetrexed or best supportive care in the real world

Basic objectives2

Others

Basic objectives -Others

To build prognostic indexes

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

overall survival

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

Patients pathologically confirmed with maliganant pleural mesothelioma in Hyogo Prefectural Amagasaki Hospital or Hyogo College of Medicine Hospital between 4/1/2007 to 3/31/2013

Key exclusion criteria

Double cancer patients.
Treated by chemotherapy, radiotherapy
before diagnosis.
Treated with trimodality therapy, extra-pleural pneumonectomy, pleurectomy, decortication, or palliative chemotherapy without pemetrexed.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name KATAOKA Yuki

Organization

Kyoto University School of Public Health at Graduate School of Medicine

Division name

Department of Healthcare Epidemiology

Zip code


Address

Yoshida Konoe-cho, Sakyo-ku, Kyoto, JAPAN

TEL

075-753-4645

Email

kataoka.yuki.23c@st.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name KATAOKA Yuki

Organization

Kyoto University School of Public Health at Graduate School of Medicine

Division name

Department of Healthcare Epidemiology

Zip code


Address

Yoshida Konoe-cho, Sakyo-ku, Kyoto, JAPAN

TEL

075-753-4645

Homepage URL


Email

kataoka.yuki.23c@st.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University School of Public Health at Graduate School of Medicine Department of Healthcare Epidemiology

Institute

Department

Personal name



Funding Source

Organization

Kyoto University School of Public Health at Graduate School of Medicine Department of Healthcare Epidemiology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Hyogo Prefectural Amagasaki Hospital
Hyogo College of Medicine Hospital

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



Other administrative information

Date of disclosure of the study information

2013 Year 09 Month 12 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/25838292

Number of participants that the trial has enrolled


Results

OBJECTIVE:
Existing prognostic indices for malignant pleural mesothelioma do not incorporate the recent advances in oncology care. The purpose of this study was to provide a prognostic index for overall survival in malignant pleural mesothelioma patients treated with chemotherapy (CTx) with pemetrexed or best supportive care in the recent clinical setting.
METHODS:
A retrospective cohort study was performed in two hospitals in Japan (2007-13). The primary outcome was overall survival. The Cox proportional hazards model was used for multivariable analyses to identify prognostic factors. A final model was chosen based on both clinical and statistical significance.
RESULTS:
A total of 283 patients (CTx: n = 228, best supportive care: n = 55) were enrolled in the study. On multivariate analysis, regimen including platinum plus pemetrexed, a performance status >0, non-epithelial histological type and Stage IV disease predicted poor overall survival in CTx patients. As hazard ratios of individual risk factors were approximately similar, a prognostic index for overall survival was constructed by counting the risk factors. Median overall survival in CTx patients decreased by each one-point increase in this count: 1030 days for zero; 658 days for one; 373 days for two; 327 days for three; 125 days for four. Internal validation using the bootstrapping technique showed robustness of the model (c-index, 0.677; 95% confidence interval, 0.624-0.729). Further, the discrimination was consistent in best supportive care patients (c-index, 0.799; 95% confidence interval, 0.725-0.874).
CONCLUSIONS:
This novel index can provide clinicians and malignant pleural mesothelioma patients with a better framework for discussing prognosis at the time of diagnosis.

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

Main results already published

Date of protocol fixation

2013 Year 09 Month 12 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 20 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete

2014 Year 02 Month 03 Day

Date analysis concluded

2014 Year 03 Month 10 Day


Other

Other related information

Data extracted from charts are age, gender, ECOG PS, symptoms(chest pain, dyspnea on exertion, body weight loss, appetite loss, fever), smoking history, asbest exposure, comorbidities, histological types, cTNM, stage(IMIG), WBC, neutrophil, lymphocyte, platelet, hemoglobin, alkaly phosphatase, lactate dehydrogenase, C reactive protein, CYFRA21-1, pleural sugar, pleural ADA, pleural CEA, pleural CYFRA21-1


Management information

Registered date

2013 Year 09 Month 12 Day

Last modified on

2015 Year 04 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013173


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name