Bone and Soft Sarcoma
Conditions
Interventions
Surgery group:Complete resection of lung metastases was performed by thoracotomy or thoracoscopic approach
SBRT group:Stereotactic body radiotherapy group 10 Gy×5
Sponsors
The First Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
16 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) With a history of bone and soft tissue sarcoma, CT indicated new pulmonary nodules, considered lung metastases with a maximum diameter =5mm, and two consecutive CT scans (1 month interval) confirmed the presence of nodules. 2) Patients with bone and soft tissue sarcoma who have failed standard treatment. Standard treatment failure was defined as lung metastases appeared or primary lung metastases growed up than 20% enlargement during or after chemotherapy with first-line chemotherapy agents (including high-dose methotrexate, doxorubicin, cisplatin, ifosfamide, etc.). 3) According to preoperative CT imaging data, all pulmonary nodules could be dissectively resected, with the maximum diameter of a single nodule =5cm, total number of double pulmonary lesions =5, and cumulative pulmonary lobes =2; Or, although the number of lesions was >5, it was limited to 1-2 lung lobes and could be enrolled by the MDT team evaluation. 4) Clinical cure can be achieved without other extrapulmonary metastatic lesions or other curative metastatic lesions. 5) Preoperative evaluation of major system functions can tolerate radiotherapy and surgery. 6) Expected survival =3 months. 7) The patients can understand the whole process of this study, voluntarily participate in and sign the informed consent. For subjects who cannot understand the informed consent form or cannot accurately express their wishes, the informed consent form can be signed by their legal representatives and bear the subject's fingerprints.
Exclusion criteria
Exclusion criteria: 1) Patients with an ECOG score of =3 and whose cardiopulmonary function assessment results could not tolerate the expected mode of surgery or radiotherapy. 2) Patients with serious heart, liver and kidney diseases, pregnant or lactating patients. 3) Uncorrected bleeding tendencies or clotting dysfunction. 4) Systemic infection or puncture site infection is present. 5) The subjects refused to join the study, and the compliance was poor. 6) According to the investigator's judgment, the patient may have other factors that may lead to the forced termination of the study, such as other serious diseases or serious abnormalities in laboratory tests or other factors that may affect the safety of the subjects (for example, ? The patient has a lot of pleural effusion and is not suitable for radiotherapy; ? Hypercentral metastases (gross target volume (GTV) or planned target volume (PTV), adjacent to or overlapping with the trachea, main bronchial tree, or esophagus(PMID: 22694017) even if the single dose of radiotherapy is reduced and the number of exposures increased, such as: 56Gy/8F, 60Gy/12F also have 22.2%-38% of grade 3 or above toxicity, or 0%-15% of grade 5 toxicity), or other reasons such as: the collection of experimental materials and biological sample, family or social factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival after recurrence; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival after recurrence;Progression-free survival rate after recurrence;Overall survival rate after recurrence;Adverse Events;Quality of Life, QOL; | — |
Countries
China
Contacts
Public ContactYin Junqiang
The First Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed