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The aim of the study is to determine if intervening with combined local therapy and chemotherapy prior to chemotherapy alone in patients with oligorecurrent and oligometastatic esophageal squamous cell carcinoma led to significant improvements in progression-free survival (PFS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm | Experimental | The arm will be treated with combined systemic therapy and local therapy such as radiation, surgery or radiofrequency ablation. |
|
| Control Arm | Active Comparator | The arm will be treated with systemic therapy alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation, Surgery or Radiofrequency ablation | Other | Patients with no more than 4 metastases located in less than 3 organs/ lymphatic drainage regions treated with combined systemic therapy and radiation, surgery or radiofrequency. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | progression-free survival will be measured as time to either progression or death | Time from the date of randomisation to the date of progression or date of death from any cause, whichever came first, assessed up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival will be measured as time to death from any cause. | The survival time from the date of randomisation to the date of death from any cause, assessed up to 3 years |
| Local control |
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Inclusion Criteria:
Patients with oligometastatic diseases and pathologically confirmed esophageal squamous cell carcinoma after initial radical treatment [i.e., completely resected surgery or radical (chemo)radiotherapy], the primary esophageal sites are controlled.
Note:
The total number of metastases is 4 or less and maximum 3 metastases in any single organ system (i.e. lung, liver). The maximum diameter for each lesion should be no more than 5 cm.
All metastases of current diagnosis did not receive local treatment such as radiotherapy, surgery, radiofrequency ablation before enrollment.
Previous chemotherapy was allowed, but no anti-tumor medication was received within 3 months prior to the start of treatment.
The measurable lesion was determined by the investigator based on the RECIST 1.1 assessment. A lesion located in a previous radiotherapy area can be considered a target lesion if it is confirmed to progress and is considered to be measurable according to RECIST 1.1.
The patient is over 18 years old and has an ECOG score of 0-1.
Estimated survival time >12 weeks.
The function of vital organs meets the following requirements:
Female subjects of childbearing age must have a negative urine or serum pregnancy test within 72 hours prior to randomization. Subjects agreed to adequate contraception during the trial.
The patient is voluntarily enrolled and obtained the informed consent form signed by the patient or his legal representative.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan Universtiy Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37980921 | Derived | Liu Q, Chen J, Lin Y, Ye J, Shen W, Luo H, Li B, Huang W, Wei S, Song J, Wang Y, Yang H, Lai S, Zhu H, Ai D, Chen Y, Deng J, Hao S, Zhao K. Systemic therapy with or without local intervention for oligometastatic oesophageal squamous cell carcinoma (ESO-Shanghai 13): an open-label, randomised, phase 2 trial. Lancet Gastroenterol Hepatol. 2024 Jan;9(1):45-55. doi: 10.1016/S2468-1253(23)00316-3. Epub 2023 Nov 18. | |
| 33626929 |
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| ID | Term |
|---|---|
| D011827 | Radiation |
| D013514 | Surgical Procedures, Operative |
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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| Systemic therapy | Drug |
|
|
Local control will be measured as time to local recurrence
| the time from the date of randomisation to the date of local failure or the last follow-up, assessed up to 3 years |
| Derived |
| Liu Q, Chen J, Li B, Ye J, Wei S, Wang Y, Yang H, Zhu Z, Lai S, Li L, Chen Y, Wang J, Xiang J, Zhao K. Local therapy for oligometastatic esophageal squamous cell carcinoma: a prospective, randomized, Phase II clinical trial. Future Oncol. 2021 Apr;17(11):1285-1293. doi: 10.2217/fon-2020-0873. Epub 2021 Feb 25. |