SBRT for Extra-cranial Oligorecurrent Tumor

NCT ID: NCT02410187

Last Updated: 2016-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2020-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

systemic therapy+palliative RT

Group Type: ACTIVE_COMPARATOR

systemic therapy (chemotherapy, hormon therapy, target therapy etc)

Intervention Type: DRUG

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.

palliative RT

Intervention Type: RADIATION

fraction size of RT = \< 3 Gy

Arm 2

systemic therapy+SBRT

Group Type: EXPERIMENTAL

SBRT

Intervention Type: RADIATION

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)

systemic therapy (chemotherapy, hormon therapy, target therapy etc)

Intervention Type: DRUG

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.

Interventions

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)

Intervention Type: RADIATION

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.

Intervention Type: DRUG

palliative RT

fraction size of RT = \< 3 Gy

Intervention Type: RADIATION

Other Intervention Names

VMAT (Volumetric Modulated Arc Therapy ); chemotherapy, hormon therapy, target therapy etc.; conventional fractionation RT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea Cancer Center Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mi-Sook Kim

Staff of Dept. of Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mi-Sook Kim, M.D. Ph.D.

Role: STUDY_CHAIR

mskim@kirams.re.kr

Central Contacts

Mi-Sook Kim, M.D. Ph.D.

Role: CONTACT

mskim@kirams.re.kr

+82-2-970-1264

Other Identifiers

K-1503-001-002

Identifier Type: -

Identifier Source: org_study_id