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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008707
Receipt No. R000010133
Scientific Title Prospective study of the efficacy and safety of chemotherapy for metastatic or progressive sarcomatoid carcinoma of the lung (carcinoma with pleomorphic, sarcomatoid, or sarcomatous elements) Hokkaido Lung Cancer Clinical Study Group Trial (HOT) 1201/North East Japan Study Group 024
Date of disclosure of the study information 2012/08/17
Last modified on 2016/08/28

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Basic information
Public title Prospective study of the efficacy and safety of chemotherapy for metastatic or progressive sarcomatoid carcinoma of the lung (carcinoma with pleomorphic, sarcomatoid, or sarcomatous elements)
Hokkaido Lung Cancer Clinical Study Group Trial (HOT) 1201/North East Japan Study Group 024
Acronym Prospective study of the efficacy and safety of chemotherapy for metastatic or progressive sarcomatoid carcinoma of the lung (HOT1201/NEJ024)
Scientific Title Prospective study of the efficacy and safety of chemotherapy for metastatic or progressive sarcomatoid carcinoma of the lung (carcinoma with pleomorphic, sarcomatoid, or sarcomatous elements)
Hokkaido Lung Cancer Clinical Study Group Trial (HOT) 1201/North East Japan Study Group 024
Scientific Title:Acronym Prospective study of the efficacy and safety of chemotherapy for metastatic or progressive sarcomatoid carcinoma of the lung (HOT1201/NEJ024)
Region
Japan

Condition
Condition Metastatic or progressive sarcomatoid carcinoma of the lung (carcinoma with pleomorphic, sarcomatoid, or sarcomatous elements)
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy and safety of chemotherapy for metastatic or progressive sarcomatoid carcinoma of the lung (carcinoma with pleomorphic, sarcomatoid, or sarcomatous elements)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Response rate
Key secondary outcomes Progression-free survival
Overall survival
Safety

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 Treatment
Type of intervention
Medicine
Interventions/Control_1 Carboplatin+Paclitaxel+Bevacizumab or Carboplatin+Paclitaxel if unfit for Bevacizumab treatment.
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1) Age: 20-74 years
2) Histologically confirmed diagnosis of sarcomatoid carcinoma of the lung.
(carcinoma with pleomorphic, sarcomatoid, or sarcomatous elements). Cytological diagnosis is not possible.
3) Stage IIIB/IV or postoperative recurrence.
4) No prior chemotherapy or post-operative recurrent disease without adjuvant chemotherapy or with at least one year interval from the last administration of adjuvant chemotherapy.
5) Patients who have measurable lesions.
6) Eastern Cooperative Oncology Group
(ECOG) Performance status of 0-1.
7) Adequate function of main organ.
White blood cell count>=3000/mm3
Absolute granulocyte count >= 1500/mm3
Hemoglobin >= 9.0g/dL
Platelet count >= 100,000/mm3
Serum bilirubin <= 1.5 mg/dL
AST and ALT <100 IU/l
Serum creatmine < 1.2 mg/dL or Ccr>=60ml/min
PaO2 (Room air) >=60Torr (or SpO2>=95%)
Proteinuria<1+
8) Life expectancy more than 3 months.
9) Written informed consent.
Key exclusion criteria 1) Previous histories of drug allergy.
2) Serious concomitant infection.
3) Usages of oral steroids or immunosuppressive agents.
4) Serious complications including severe cardiovascular disease, cerebrovascular disease, severe hypertension, active peptic ulcer, or uncontrolled diabetes.
5) Interstitial pneumonia or pulmonary fibrosis on chest CT scans.
6) Severe pleural, abdominal, or cardiac effusion.
7) Major surgical procedures within 3 weeks or prior systemic therapy including radiotherapy within 2 weeks prior to study entry .
8) Patient in acknowledgment of hemoptysis (2.5 ml or more) or clinically important bleeding or a clot-related event.
9) Uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 90 mmHg).
10) Brain metastasis with uncontrollable symptoms.
11) Tumor permeation to chest great vessels.
12) Cavity in tumor.
13) Receiving anticoagulant drug (except aspirin under 325mg/day).
14) Patients with active concomitant malignancy.
15) Pregnant or lactating women.
16) Inappropriate patients judged by physicians.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Oizumi
Organization Hokkaido Cancer Center
Division name Department of Respiratory Medicine
Zip code
Address 3-54 Kikusui 4-2, Shiroishi-ku, Sapporo, 003-0804 Japan
TEL 011-811-9111
Email soizumi@sap-cc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Oizumi
Organization Hokkaido Cancer Center
Division name Department of Respiratory Medicine
Zip code
Address 3-54 Kikusui 4-2, Shiroishi-ku, Sapporo, 003-0804 Japan
TEL 011-811-9111
Homepage URL
Email soizumi@sap-cc.go.jp

Sponsor
Institute Hokkaido Lung Cancer Clinical Study Group
North East Japan Study Group
Institute
Department

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
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
2012 Year 08 Month 17 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 Open public recruiting
Date of protocol fixation
2012 Year 07 Month 21 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 08 Month 17 Day
Last modified on
2016 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010133

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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