UMIN-CTR Clinical Trial

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 Satoshi Middle name Last name Oizumi
Organization	Hokkaido Cancer Center
Division name	Department of Respiratory Medicine
Zip code	003-0804
Address	3-54 Kikusui 4-2, Shiroishi-ku, Sapporo, 003-0804 Japan
TEL	011-811-9111
Email	soizumi@hokkaido.med.or.jp

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

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

Funding Source
Organization	Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The ethics review boards, Hokkaido Cancer Center
Address	3-54 Kikusui 4-2, Shiroishi-ku, Sapporo, 003-0804 Japan
Tel	011-811-9111
Email	soizumi@hokkaido.med.or.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	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	Main results already published
Date of protocol fixation	2012 Year 07 Month 21 Day
Date of IRB	2012 Year 07 Month 21 Day
Anticipated trial start date	2012 Year 08 Month 18 Day
Last follow-up date	2020 Year 03 Month 31 Day
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	2021 Year 08 Month 23 Day

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