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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
- Source :
- Japanese Journal of Clinical Oncology. 44:765-769
- Publication Year :
- 2014
- Publisher :
- Oxford University Press (OUP), 2014.
-
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 non-inferiority 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 accrued from 28 Japanese institutions over 6 years. The primary endpoint in the Phase II part is the proportion of completion of pre-operative chemotherapy without progressive disease and overall survival in the Phase III part. The secondary endpoints are progression-free survival, response rate of pre-operative chemotherapy, pathological response rate, proportion of preservation of diseased limbs, disease control rate and proportion of adverse events. This trial has been registered in the UMIN Clinical Trials Registry as UMIN000013175 [http://www.umin.ac.jp/ctr/index.htm].
- Subjects :
- Adult
Male
Oncology
Cancer Research
medicine.medical_specialty
medicine.medical_treatment
Soft Tissue Neoplasms
Docetaxel
Deoxycytidine
Disease-Free Survival
Japan
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
Radiology, Nuclear Medicine and imaging
Ifosfamide
Postoperative Period
Aged
Neoplasm Staging
Chemotherapy
business.industry
Soft tissue sarcoma
Standard treatment
Sarcoma
General Medicine
Middle Aged
medicine.disease
Gemcitabine
Chemotherapy regimen
Treatment Outcome
Doxorubicin
Female
Taxoids
Tomography, X-Ray Computed
business
Progressive disease
Follow-Up Studies
medicine.drug
Subjects
Details
- ISSN :
- 14653621, 03682811, and 00001317
- Volume :
- 44
- Database :
- OpenAIRE
- Journal :
- Japanese Journal of Clinical Oncology
- Accession number :
- edsair.doi.dedup.....ab9cf2b68013df83776fba9624efec09