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The aim of this phase II trial is to assess progress-free survival, local control, overall survival, safety and tolerability of SBRT to treat patients with oligometastases in esophageal squamous cell carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm | Experimental | Patients in this arm will receive a treatment of SBRT for their oligometastatic lesions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT | Radiation | Patients with 1-4 metastases located in less than 2 organs/ lymphatic drainage regions that are 5 cm or less from each other and simultaneously treated with SBRT. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | progression-free survival will be measured as time to either progression or death | The survival time from the date each patient enrolled to the date of progression or date of death from any cause, whichever came first, assessed up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Local control | Local control will be measured as time to local recurrence | the time from the date each patient enrolled to the date of local failure or the last follow-up, assessed up to 5 years. |
| overall survival |
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Inclusion Criteria:
Exclusion Criteria:
Progression of primary tumor site at time of registration.
Metastases with indistinct borders making targeting not feasible.
Known brain metastases.
Prior palliative radiotherapy to metastases.
Metastases located within 3 cm of the previously irradiated structures:
a).Spinal cord previously irradiated >80Gy(Biological equivalent dose with α/β=2), b).Brachial plexus previously irradiated to > 100Gy(Biological equivalent dose with α/β=2), c).Small intestine, large intestine, or stomach previously irradiated to > 90Gy (Biological equivalent dose with α/β=2), d).Whole lung previously irradiated with prior V20Gy > 30% (delivered in ≤ 3 Gy/fraction), e)Metastasis irradiated with SBRT.
Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives.
Drug addiction,Alcoholism or AIDS.
Patients with severe organ dysfunction or Acute bacterial or fungal infection who are considered not suitable to enroll the study at the time of registration.
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| Name | Affiliation | Role |
|---|---|---|
| Kuaile Zhao, MD. | Fudan Universtiy Shanghai Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan Universtiy Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32417405 | Derived | Liu Q, Zhu Z, Chen Y, Deng J, Ai D, Liu Q, Wang S, Wu S, Chen J, Zhao K. Phase 2 Study of Stereotactic Body Radiation Therapy for Patients with Oligometastatic Esophageal Squamous Cell Carcinoma. Int J Radiat Oncol Biol Phys. 2020 Nov 1;108(3):707-715. doi: 10.1016/j.ijrobp.2020.05.003. Epub 2020 May 14. |
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Overall survival will be measured as time until death from any cause
| The survival time from the date each patient enrolled to the date of death or the last follow-up, assessed up to 5 years. |