NCT02410187

SBRT for Extra-cranial Oligorecurrent Tumor

Stereotactic Body Radiotherapy for Extra-cranial Oligorecurrent Tumor: Randomized Phase II Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (estimated)
• Sponsor: Korea Cancer Center Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-03-01
• Completion: 2020-03-01
• First posted: 2015-04-07
• Last updated: 2016-03-03