UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008707
Receipt number 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 2021/08/23 13:49:23

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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 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 or person

Institute

Hokkaido Lung Cancer Clinical Study Group
North East Japan Study Group

Institute

Department

Personal name



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

Value
https://center6.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