SBRT for Extra-cranial Oligorecurrent Tumor

NCT02410187 | Unknown Phase 2

• 1 other identifier: K-1503-001-002
• Study Type: interventional
• Target: 1
• Locations: 0 countries
• Sites: N/A

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

Keywords

stereotactic body radiotherapy

Outcome Measures

Primary Outcomes (1)

• disease progression free survival rate

  2 years

Secondary Outcomes (3)

• overall survival rate

  2 years

• local control rate

  2 years

• Number of participants with radiation induced acute or late toxicity

  2 years

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

systemic therapy+palliative RT

Drug: systemic therapy (chemotherapy, hormon therapy, target therapy etc); Radiation: palliative RT

Arm 2

EXPERIMENTAL

systemic therapy+SBRT

Radiation: SBRT; Drug: systemic therapy (chemotherapy, hormon therapy, target therapy etc)

Interventions

SBRT 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)

Also known as: VMAT (Volumetric Modulated Arc Therapy )

Arm 2

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

Also known as: chemotherapy, hormon therapy, target therapy etc.

Arm 1; Arm 2

palliative RT RADIATION

fraction size of RT = \< 3 Gy

Also known as: conventional fractionation RT

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea Cancer Center Hospital: lead

MeSH Terms

Conditions

Recurrence

Interventions

Radiotherapy, Intensity-Modulated; Drug Therapy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Mi-Sook Kim, M.D. Ph.D.

  mskim@kirams.re.kr

  STUDY CHAIR

Central Study Contacts

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

CONTACT

+82-2-970-1264; mskim@kirams.re.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff of Dept. of Radiation Oncology

Study Record Dates

• First Submitted: March 20, 2015
• First Posted: April 7, 2015
• Study Start: March 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2020
• Last Updated: March 3, 2016

Record last verified: 2016-03