Recurrent CancerPhase 2NCT02410187
SBRT for Extra-cranial Oligorecurrent Tumor
A Phase 2 study testing SBRT, systemic therapy (chemotherapy, hormon therapy, target therapy etc) and palliative RT in people with Recurrent Cancer, run by Korea Cancer Center Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Cancer
- What is being tested?
- SBRT, systemic therapy (chemotherapy, hormon therapy, target therapy etc) and palliative RT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Mar 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Recurrent Cancer
- Being tested
- SBRT, systemic therapy (chemotherapy, hormon therapy, target therapy etc), palliative RT
- Keywords
- stereotactic body radiotherapy
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
Also called VMAT (Volumetric Modulated Arc Therapy )
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)Drug
Also called 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.
palliative RTRadiation
Also called conventional fractionation RT
fraction size of RT = < 3 Gy
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | systemic therapy+palliative RT Receives: Drug: systemic therapy (chemotherapy, hormon therapy, target therapy etc); Radiation: palliative RT |
| Arm 2 | Experimental | systemic therapy+SBRT Receives: Radiation: SBRT; Drug: systemic therapy (chemotherapy, hormon therapy, target therapy etc) |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease progression free survival rate
Measured: 2 years
Secondary outcomes (3)
overall survival rate
Measured: 2 years
local control rate
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startMar 2016
- Primary completionMar 2018 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea Cancer Center Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mi-Sook Kim, Korea Cancer Center Hospital
- Investigators
- Mi-Sook Kim, M.D. Ph.D., Study chair, mskim@kirams.re.kr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410187
- Sponsor's protocol ID
- K-1503-001-002
- Status last verified
- Mar 2016
- First submitted
- 20 Mar 2015
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Body Radiotherapy for Extra-cranial Oligorecurrent Tumor: Randomized Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT02410187
- Acronym / sponsor ID
- K-1503-001-002
- Conditions
- Recurrent Cancer
- Keywords
- stereotactic body radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Korea Cancer Center HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 7 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: systemic therapy (chemotherapy, hormon therapy, target therapy etc), Radiation: palliative RTsystemic therapy+palliative RT |
| Arm 2 | Experimental | Radiation: SBRT, Drug: systemic therapy (chemotherapy, hormon therapy, target therapy etc)systemic therapy+SBRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBRTAlso: VMAT (Volumetric Modulated Arc Therapy )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) | Radiation | Arm 2 |
| systemic therapy (chemotherapy, hormon therapy, target therapy etc)Also: 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. | Drug | Arm 1, Arm 2 |
| palliative RTAlso: conventional fractionation RTfraction size of RT = < 3 Gy | Radiation | Arm 1 |
Primary outcome
disease progression free survival rate
Time frame: 2 years
3 secondary outcomes
overall survival rate
Time frame: 2 years
local control rate
Time frame: 2 years
Number of participants with radiation induced acute or late toxicity
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mi-Sook Kim, M.D. Ph.D. study chair
mskim@kirams.re.kr
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SBRT, systemic therapy (chemotherapy, hormon therapy, target therapy etc) and palliative RT in people with Recurrent Cancer, run by Korea Cancer Center Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mi-Sook Kim, M.D. Ph.D. (+82-2-970-1264, mskim@kirams.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease progression free survival rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2016; AzTrials last refreshed its copy on 3 Nov 2026.