Phase II study of dose escalation and concentration in stereotactic body radiotherapy (SBRT) for metastatic pulmonary or liver tumors from colorectal cancer

Phase II study of dose escalation and concentration in stereotactic body radiotherapy (SBRT) for metastatic pulmonary or liver tumors from colorectal cancer - Phase II study of SBRT for metastatic pulmonary or liver tumors from colorectal cancer

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026577

Enrollment

Registered

2017-03-16

Start date

2017-03-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pulmonary or liver metastasis from colorectal cancer

Interventions

stereotactic body radiation therapy 50-60Gy/5fr(60% isodose)/5-12days

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
2-year local control of pulmonary and liver metastasis from colorectal cancer	—

Secondary

Measure	Time frame
overall survival time, 2-year overall survival, local control time of pulmonary metastasis, toxicities proportion, severe toxicities proportion	—

Countries

Japan

Contacts

Public ContactTsurugai Yuichiro

Ofuna Chuo Hospital Radiation Oncology Center

tatesen2000@gmail.com0467-45-2111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026