2014
DOI: 10.1093/jjco/hyu080
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A Randomized Phase II/III Trial of Perioperative Chemotherapy with Adriamycin Plus Ifosfamide Versus Gemcitabine Plus Docetaxel for High-grade Soft Tissue Sarcoma: Japan Clinical Oncology Group Study JCOG1306

Abstract: A randomized Phase II/III trial was planned to commence in March 2014. Perioperative chemotherapy with adriamycin plus ifosfamide is the current standard treatment for T2bN0M0 high-grade non-round cell soft tissue sarcoma. The purpose of this study is to confirm the noninferiority of perioperative chemotherapy with gemcitabine and docetaxel to adriamycin plus ifosfamide for patients with T2bN0M0 or any TN1M0 non-round cell soft tissue sarcoma in the extremities and body wall. A total of 140 patients will be ac… Show more

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Cited by 14 publications
(10 citation statements)
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“…Taken together, the JCOG BSTTSG is now conducting a randomized phase II/III study, JCOG1306, to elucidate the efficacy and safety of perioperative chemotherapy by GD comparing with DOX+IFO for operable high-grade STS [26]. …”
Section: Discussionmentioning
confidence: 99%
“…Taken together, the JCOG BSTTSG is now conducting a randomized phase II/III study, JCOG1306, to elucidate the efficacy and safety of perioperative chemotherapy by GD comparing with DOX+IFO for operable high-grade STS [26]. …”
Section: Discussionmentioning
confidence: 99%
“…It may also be necessary to wait for the final results of the ISG-STS1001 trial. At present, we are conducting a randomized phase 2/3 study of perioperative chemotherapy for the treatment of high-risk STS arising in the extremities and trunk, by comparing DXR plus IFM with gemcitabine plus docetaxel, JCOG1306 [18]. In JCOG1306, we aim to confirm non-inferiority of gemcitabine plus docetaxel to DXR plus IFM since the former regimen is less toxic and has a possibility of combination with other drug including molecular-target therapy in the future therapeutic development.…”
Section: Discussionmentioning
confidence: 99%
“…Soft-tissue sarcoma is a rare neoplasm of mesenchymal origin. As biological properties, differentiation, histological origin, local invasiveness, sensitivity to radiotherapy and chemotherapy, and incidence of local recurrence and metastasis vary significantly, its treatment should be selected on the basis of the nature of the tumor and should be decided on a case-to-case basis [ 1 - 4 ]. The treatment modality is selected based on the histological grade of the tumor determined via pathological examination of the specimen from a lesion, which is a representative parameter of tumor activity.…”
Section: Introductionmentioning
confidence: 99%
“…The Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC) grading system is used for soft-tissue sarcomas defined by tumor differentiation, mitosis count, and tumor necrosis; this system is commonly the basis for making decisions about the use of chemotherapy and definition of surgical margins [ 5 ]. For example, neoadjuvant and adjuvant chemotherapy are used only for high-grade sarcoma (FNCLCC grade II and III) under the hypothesis that therapeutic reagents are effective only for sarcoma cells with a high mitotic rate [ 1 ]. On the other hand, conservative surgery with a closer surgical margin is used for low-grade sarcomas, as they show less local invasiveness [ 2 , 3 ].…”
Section: Introductionmentioning
confidence: 99%