UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026577 |
|---|---|
| Receipt number | 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 13:25:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
tatesen2000@gmail.com
Sponsor or person
Institute
Ofuna Chuo Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012847
