SBRT for Extra-cranial Oligorecurrent Tumor

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

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.

Study Overview

• Status: Unknown
• Conditions: Recurrent Cancer
• Intervention / Treatment: Drug: systemic therapy (chemotherapy, hormon therapy, target therapy etc); Radiation: palliative RT; Radiation: SBRT

• Study Type: Interventional
• Enrollment (Anticipated): 1
• Phase: Phase 2

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1; systemic therapy+palliative RT	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.; Other Names: chemotherapy, hormon therapy, target therapy etc.; Radiation: palliative RT; fraction size of RT = < 3 Gy; Other Names: conventional fractionation RT
Experimental: Arm 2; systemic therapy+SBRT	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.; Other Names: chemotherapy, hormon therapy, target therapy etc.; 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); Other Names: VMAT (Volumetric Modulated Arc Therapy )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
disease progression free survival rate	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival rate		2 years
local control rate		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.	2 years

Collaborators and Investigators

• Sponsor: Korea Cancer Center Hospital
• Investigators: Study Chair: Mi-Sook Kim, M.D. Ph.D., mskim@kirams.re.kr

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: March 20, 2015
• First Submitted That Met QC Criteria: April 1, 2015
• First Posted (Estimate): April 7, 2015

Study Record Updates

• Last Update Posted (Estimate): March 3, 2016
• Last Update Submitted That Met QC Criteria: March 2, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: stereotactic body radiotherapy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: K-1503-001-002