UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of dose escalation and concentration in stereotactic body radiotherapy (SBRT) for metastatic pulmonary or liver tumors from colorectal cancer
Title of the study (Brief title)	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	Atsuya Takeda, M.D., Ph.D.
Organization	Ofuna Chuo Hospital
Division name	Radiation Oncology Center
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	Tsurugai Yuichiro
Organization	Ofuna Chuo Hospital
Division name	Radiation Oncology Center
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 03 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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