A Phase 2 interventional study of SBRT and systemic therapy (chemotherapy, hormon therapy, target therapy etc) in Recurrent Cancer, sponsored by Korea Cancer Center Hospital. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-03.
Sponsored by Korea Cancer Center Hospital · Phase 2, Interventional, and Treatment
Clinical experience has shown that metastasis can often be limited in number and location, and thus amenable to local treatment. The term oligometastasis describes an intermediate state of cancer spread between localized disease and widespread metastasis. The implication of such an intermediate state is that the disease can be cured by using metastasis-directed therapy. Historically, in some patients with oligometastases in the liver or lungs, surgical resection was often indicated, as abundant evidence suggested it could improve progression-free or overall survival. Recently, several studies have reported promising outcomes of >80% local control with Stereotactic Body Radiotherapy (SBRT) in patients with lung or liver oligometastases. Nonetheless, very few studies have focused on non-liver, non-lung extracranial oligometastatic lesions treated with SBRT, and such studies have limitations of a retrospective nature and small sample sizes.Because allmost studies are based on single-arm studies without appropriate controls, the level of evidence to support SBRT is weak. Randomized trials are therefore necessary to establish the utility of SBRT for oligometastatic disease.
This study is designed as a randomized phase II study. Patients will be randomized between current standard treatment (Arm 1) versus standard treatment +SBRT (Arm 2) to all known disease.
Korea Cancer Center Hospital is the lead sponsor of 15 studies on the registry; none are open to participants now.
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Exclusion Criteria:
systemic therapy+palliative RT
Drug: systemic therapy (chemotherapy, hormon therapy, target therapy etc) · Radiation: palliative RT
systemic therapy+SBRT
Radiation: SBRT · Drug: systemic therapy (chemotherapy, hormon therapy, target therapy etc)
10 Gy x 3 - 20 Gy x 3 (BED 60Gy-180 Gy) or 8 Gy x 4 - 17 Gy x 4 (BED 58-184 Gy)
Also known as: VMAT (Volumetric Modulated Arc Therapy )
Physicians can choose all the options available chemotherapy, hormon therapy, target therapy etc. Use of chemotherapy schemes containing potent enhancers of radiation damage (e.g. gemcitabine,adriamycin) are discouraged within the first month after SBRT.
Also known as: chemotherapy, hormon therapy, target therapy etc.
fraction size of RT = \< 3 Gy
Also known as: conventional fractionation RT
disease progression free survival rate
Time frame: 2 years
overall survival rate
Time frame: 2 years
local control rate
Time frame: 2 years
Number of participants with radiation induced acute or late toxicity
Acute and late toxicities would be evaluated using the Common Terminology Criteria of Adverse Events (CTCAE) version 4.0 and the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer (RTOG/EORTC) radiation morbidity criteria, respectively.
Time frame: 2 years
No study locations are listed for this record.
This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Korea Cancer Center Hospital