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For localized soft tissue sarcomas (STS) of the extremities, limb-sparing or conservative surgery with perioperative radiotherapy (RT) is the standard of care. However, several challenges persist. Notably, there are exceedingly high rates of distant metastatic recurrence even after surgical resection and RT, and conventional fractionated radiotherapy has a prolonged duration (5-6 weeks). With advancements in RT technology, the gradual expansion of hypofractionated radiotherapy regimens enables significantly shorter treatment durations. Promising recent reports on 1-week hypofractionated RT regimens, such as the 5X5 Gy RT regimens, have demonstrated reasonable local control and acceptable toxicity in resectable STS.Addressing the challenge of distant metastasis, previous studies have indicated that AI regimens are expected to eliminate micrometastases and improve survival in patients with STS at a high risk of distant relapse. Therefore, the goal of this clinical trial is to investigate whether hypofractionated RT combined with a sequential chemotherapy(AI regimens)can enhance short-term treatment efficacy for extremity STS patients without compromising local control rates and increasing related toxicities
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionated Radiotherapy | Experimental | The patients in the study underwent a 1-week course of hypofractionated radiotherapy. Following the completion of radiotherapy, chemotherapy with the AI regimen (doxorubicin + ifosfamide) was initiated one week later. The AI regimen chemotherapy was administered for a duration of 9 weeks. Subsequently, surgery was scheduled to commence 1-2 weeks after the completion of chemotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated Radiotherapy | Radiation | Hypofractionated radiotherapy Preoperative hypofractionated 5x5 Gy radiotherapy (5 consecutive days) prescribed on planned target volume |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of EORTC-STBSG classifications A-C (less than 10% tumour residual) | Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative wound complications | 3 months | |
| Overall survival | 24 months after treatment completion | |
| Local control |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong Yang, Doctor | Contact | 18813019084 | dr_yangyong1983@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yong Yang, Doctor | Director of the radiotherapy department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Recruiting | Fuzhou | Fujian | 350001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31081028 | Background | Blay JY, Honore C, Stoeckle E, Meeus P, Jafari M, Gouin F, Anract P, Ferron G, Rochwerger A, Ropars M, Carrere S, Marchal F, Sirveaux F, Di Marco A, Le Nail LR, Guiramand J, Vaz G, Machiavello JC, Marco O, Causeret S, Gimbergues P, Fiorenza F, Chaigneau L, Guillemin F, Guilloit JM, Dujardin F, Spano JP, Ruzic JC, Michot A, Soibinet P, Bompas E, Chevreau C, Duffaud F, Rios M, Perrin C, Firmin N, Bertucci F, Le Pechoux C, Le Loarer F, Collard O, Karanian-Philippe M, Brahmi M, Dufresne A, Dupre A, Ducimetiere F, Giraud A, Perol D, Toulmonde M, Ray-Coquard I, Italiano A, Le Cesne A, Penel N, Bonvalot S; NETSARC/REPPS/RESOS and French Sarcoma Group-Groupe d'Etude des Tumeurs Osseuses (GSF-GETO) Networks. Surgery in reference centers improves survival of sarcoma patients: a nationwide study. Ann Oncol. 2019 Jul 1;30(7):1143-1153. doi: 10.1093/annonc/mdz124. | |
| 27733375 |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069473 | Radiation Dose Hypofractionation |
| ID | Term |
|---|---|
| D019583 | Dose Fractionation, Radiation |
| D011879 | Radiotherapy Dosage |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| 3 cycles of AI | Drug | Three courses of doxorubicin and ifosfamide (AI, doxorubicin 75 mg/sqm and ifosfamide 10 g/sqm with prophylactic mesna) |
|
| 24 months after treatment completion |
| Background |
| Gronchi A, Stacchiotti S, Verderio P, Ferrari S, Martin Broto J, Lopez-Pousa A, Llombart-Bosch A, Dei Tos AP, Collini P, Jurado JC, De Paoli A, Donati DM, Poveda A, Quagliuolo V, Comandone A, Grignani G, Morosi C, Messina A, De Sanctis R, Bottelli S, Palassini E, Casali PG, Picci P. Short, full-dose adjuvant chemotherapy (CT) in high-risk adult soft tissue sarcomas (STS): long-term follow-up of a randomized clinical trial from the Italian Sarcoma Group and the Spanish Sarcoma Group. Ann Oncol. 2016 Dec;27(12):2283-2288. doi: 10.1093/annonc/mdw430. Epub 2016 Oct 11. |
| 32054730 | Background | Kalbasi A, Kamrava M, Chu FI, Telesca D, Van Dams R, Yang Y, Ruan D, Nelson SD, Dry SM, Hernandez J, Chmielowski B, Singh AS, Bukata SV, Bernthal NM, Steinberg ML, Weidhaas JB, Eilber FC. A Phase II Trial of 5-Day Neoadjuvant Radiotherapy for Patients with High-Risk Primary Soft Tissue Sarcoma. Clin Cancer Res. 2020 Apr 15;26(8):1829-1836. doi: 10.1158/1078-0432.CCR-19-3524. Epub 2020 Feb 13. |
| 33798613 | Background | Gobo Silva ML, Lopes de Mello CA, Aguiar Junior S, D'Almeida Costa F, Stevanato Filho PR, Santoro Bezerra T, Nakagawa SA, Nascimento AG, Werneck da Cunha I, Spencer Sobreira Batista RM, Nicolau Daher UR, Da Cruz Formiga MN, Germano JN, Catin Kupper BE, De Assis Pellizzon AC, Lopes A. Neoadjuvant hypofractionated radiotherapy and chemotherapy for extremity soft tissue sarcomas: Safety, feasibility, and early oncologic outcomes of a phase 2 trial. Radiother Oncol. 2021 Jun;159:161-167. doi: 10.1016/j.radonc.2021.03.033. Epub 2021 Mar 31. |