UMIN-CTR Clinical Trial

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

pulmonary or liver metastasis from colorectal cancer

Classification by specialty

Gastroenterology	Pneumology	Gastrointestinal surgery
Chest surgery	Radiology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Ofuna Chuo Hospital

Institute

Department

Personal name

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大船中央病院

Date of disclosure of the study information

2017

Year

03

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

03

Month

16

Day

Last modified on

2017

Year

03

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012847