SBRT for Extra-cranial Oligorecurrent Tumor

Study Overview
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Brief Summary
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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.

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

Conditions
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Recurrent Cancer

Intervention / Treatment
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* Radiation: SBRT
* Drug: systemic therapy (chemotherapy, hormon therapy, target therapy etc)
* Radiation: palliative RT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stereotactic body radiotherapy