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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02410187
Other study ID # K-1503-001-002
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received March 20, 2015
Last updated March 2, 2016
Start date March 2016
Est. completion date March 2020

Study information

Verified date March 2016
Source Korea Cancer Center Hospital
Contact Mi-Sook Kim, M.D. Ph.D.
Phone +82-2-970-1264
Email mskim@kirams.re.kr
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1
Est. completion date March 2020
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- age <18 years old

- ECOG score: 0-2

- number of distant metastases: 1-5

- all cancers (except lymphoma, myeloma, and germ cell tumor)

- status of primary lesion: cured

- pathologically confirmed cancer

- life expectancy: over 6 months

Exclusion Criteria:

- recurrent lesion which had been treated by radiotherapy

- complete response after systemic therapy

- patients who cannot be treated with SBRT due to any reason.

- pregnancy or breast-feeding

- malignant pleural effusion

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Radiation:
SBRT
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)
Drug:
systemic therapy (chemotherapy, hormon therapy, target therapy etc)
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.
Radiation:
palliative RT
fraction size of RT = < 3 Gy

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Korea Cancer Center Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary disease progression free survival rate 2 years No
Secondary overall survival rate 2 years No
Secondary local control rate 2 years No
Secondary 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. 2 years Yes
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