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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026577
Receipt No. R000012847
Scientific Title Phase II study of dose escalation and concentration in stereotactic body radiotherapy (SBRT) for metastatic pulmonary or liver tumors from colorectal cancer
Date of disclosure of the study information 2017/03/16
Last modified on 2017/03/16

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Basic information
Public title Phase II study of dose escalation and concentration in stereotactic body radiotherapy (SBRT) for metastatic pulmonary or liver tumors from colorectal cancer
Acronym Phase II study of SBRT for metastatic pulmonary or liver tumors from colorectal cancer
Scientific Title Phase II study of dose escalation and concentration in stereotactic body radiotherapy (SBRT) for metastatic pulmonary or liver tumors from colorectal cancer
Scientific Title:Acronym Phase II study of SBRT for metastatic pulmonary or liver tumors from colorectal cancer
Region
Japan

Condition
Condition pulmonary or liver metastasis from colorectal cancer
Classification by specialty
Gastroenterology Pneumology Gastrointestinal surgery
Chest surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the local control and toxicities of stereotactic body radiotherapy for pulmonary and liver metastasis from colorectal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 2-year local control of pulmonary and liver metastasis from colorectal cancer
Key secondary outcomes overall survival time, 2-year overall survival, local control time of pulmonary metastasis, toxicities proportion, severe toxicities proportion

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 stereotactic body radiation therapy
50-60Gy/5fr(60% isodose)/5-12days
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
90 years-old >=
Gender Male and Female
Key inclusion criteria 1.Diagnosed as pulmonary or liver metastasis from colorectal cancer
a.Histologically confirmed pulmonary or liver metastasis from colorectal cancer
b.Graphically diagnosed pulmonary or liver metastasis from colorectal cancer with CT, MRI or US in following up after histologically confirmed colorectal cancer
2.No other metastasis is confirmed by FDG-PET and brain MRI within 60 days
3.pulmonary or liver metastasis from colorectal cancer: 1-3 tumors. 1-2 pulmonary metastases in ipsilateral lung
4.out of indication or refusal to surgical resection
5.enable to irradiate those lesions respecting dose constraint
6.no history of irradiation to the lung or the liver
7.at least 2 weeks passed after the latest chemotherapy
8.ECOG PS=0-2
9.Age>=20 and <=90
10.GOLD stage 0-II in patients with lung metastases
11.Preserved bone marrow, renal and heart function
a.WBC:>=2000/mm3
b.Platelet:>=3x104/mm3
c.Hgb:>=8.0g/dl
d.Toral bilirubin:<=2.0mg/dl
e.Cr:<=2.0mg/dl
f.PT:>=50%
12.Written informed consent
Key exclusion criteria 1.No apparent interstitial pneumonitis or fibrosis in patients with pulmonary metastasis
2.No liver cirrhosis more than Child-Pugh score 7 in patients with liver metastasis
3.No active inflammation except for using ointment
4.No multiple cancer (except for carcinoma in-situ)
5.No pregnancy or breast feeding
6.No psychiatric disorder
7.No steroid administration
8.No concurrent chemotherapy
9.No fever above 38
10.No cough with opioid drug
11.No other reason that clinician judged as improper
Target sample size 23

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsuya Takeda, M.D., Ph.D.
Organization Ofuna Chuo Hospital
Division name Radiation Oncology Center
Zip code
Address 6-2-24Ofuna, Kamakura-shi, Kanagawa, Japan 247-0056
TEL 0467-45-2111
Email takeda@1994.jukuin.keio.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsurugai Yuichiro
Organization Ofuna Chuo Hospital
Division name Radiation Oncology Center
Zip code
Address 6-2-24 Ofuna Kamakura
TEL 0467-45-2111
Homepage URL
Email tatesen2000@gmail.com

Sponsor
Institute Ofuna Chuo Hospital
Institute
Department

Funding Source
Organization Self funding
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 大船中央病院

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 16 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 Enrolling by invitation
Date of protocol fixation
2017 Year 03 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 16 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
2017 Year 03 Month 16 Day
Last modified on
2017 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012847

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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