Unique ID issued by UMIN | UMIN000013175 |
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Receipt number | R000015110 |
Scientific Title | Randomized phase II/III study of adjuvant chemotherapy with Adriamycin+Ifosfamide vs Gemcitabine+Docetaxel for high-grade soft tissue sarcoma (JCOG1306, AI vs GD for STS RPII/III) |
Date of disclosure of the study information | 2014/02/17 |
Last modified on | 2021/01/05 16:19:55 |
Randomized phase II/III study of adjuvant chemotherapy with Adriamycin+Ifosfamide vs Gemcitabine+Docetaxel for high-grade soft tissue sarcoma (JCOG1306, AI vs GD for STS RPII/III)
Randomized phase II/III study of adjuvant chemotherapy with Adriamycin+Ifosfamide vs Gemcitabine+Docetaxel for high-grade soft tissue sarcoma(JCOG1306, AI vs GD for STS RPII/III)
Randomized phase II/III study of adjuvant chemotherapy with Adriamycin+Ifosfamide vs Gemcitabine+Docetaxel for high-grade soft tissue sarcoma (JCOG1306, AI vs GD for STS RPII/III)
Randomized phase II/III study of adjuvant chemotherapy with Adriamycin+Ifosfamide vs Gemcitabine+Docetaxel for high-grade soft tissue sarcoma(JCOG1306, AI vs GD for STS RPII/III)
Japan |
soft tissue sarcoma
Orthopedics |
Malignancy
NO
To evaluate the efficacy and feasibility of neoadjuvant chemotherapy and adjuvant chemotherapy using GD (gemcitabin and docetaxel) compared with AI (adriamycin and ifosfamide), on the patients with T2bN0M0, anyTN1M0 soft tissue sarcomas(including local recurrence) in the extremities and trunk.
Safety,Efficacy
Confirmatory
Phase II,III
PhaseII: Proportion of completion of preoperative chemotherapy without progression disease. Phase III: Overall survival
PhaseII/III: Progression-free survival. Response rate of preoperative chemotherapy, Pathological response rate of preoperative chemotherapy, Proportion of preservation of diseased limb(extremities),Disease control rate (extremities and trunks), Adverse events, Serious adverse events, Respiratory-related adverse events and Postoperative complication.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine | Maneuver |
A: Three courses of preoperative chemotherapy with adriamycin(30mg/m2/day, day 1-2) and ifosphamide(2g/m2/day, day 1-5) every three weeks followed by surgical resection and two courses of postperative chemotherapy after that
B: Three courses of preoperative chemotherapy with gemcitabin(900mg/m2/day, day 1,8) and docetaxel (70mg/m2/day, day 8) every three weeks followed by surgical resection and two courses of postperative chemotherapy after that
20 | years-old | <= |
70 | years-old | >= |
Male and Female
1) Grade 2 or 3 (FNCLCC histological grading system) non-round cell soft-tissue sarcoma (NRC-STS) with histology of undifferentiated pleomorphic sarcoma, fibrosarcoma, leiomyosarcoma, synovial sarcoma, liposarcoma, pleomorphic rhabdomyosarcoma, angiosarcoma, malignant peripheral nerve sheth tumor or undifferentiated sarcoma (WHO classification) using open biopsy specimen
2) Primary tumor or first local recurrent tumor
3) 10 or more unstained tumor tissue slides are available
4) UJCC/AJCC TNM (7th edition): T2bN0M0 or any TN1M0 (in case of primary tumor)
5) No distant metastases (in case of first local recurrent tumor)
6) Tumor in the extremities or trunk
7) Having measurable lesion on MRI axial section
8) Resectable with appropriate margins
9) Age >= 20 and =< 70
10) An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
11) No history of chemotherapy nor radiation therapy for any cancer including NRC-STS
12) Sufficient organ function
13) No abnormal ECG findings
14) Not diagnosed as interstitial pneumonia, pulmonary emphysema nor pulmonary fibrosis with chest CT finding
15) Written informed consent.
1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or intramucosal tumors curatively treated with local therapy
2) Active infection requiring systemic therapy
3) Body temperature >= 38 degrees Celsius
4) Women in pregnant, possibly pregnant or breast feeding
5) Psychiatric disease
6) Patients requiring systemic steroid medication
7) Unstable angina within 3 weeks, or with a history of myocardial infarction
8) Poorly controlled hypertension
9) Poorly controlled diabetes mellitus or routine administration of insulin
10) Positive HBs antigen
140
1st name | |
Middle name | |
Last name | Yukihide Iwamoto, MD, PhD roll: Study Chair |
Kyushu University Hospital
Department of Orthopaedic Surgery
3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, JAPAN
092-642-5488(81-92-642-5488)
yiwamoto@ortho.med.kyushu-u.ac.jp
1st name | |
Middle name | |
Last name | Kazuhiro Tanaka, MD, PhD |
JCOG1306 Coordinating Office
Department of Orthopaedic Surgery, Oita University Hospital
1-1, Idaigaoka, Hasamamachi, Yuhu city, Oita, 879-5593, JAPAN
097-586-5872(81-97-586-5872)
http://www.jcog.jp/
JCOG_sir@ml.jcog.jp
Japan Clinical Oncology Group (JCOG)
Ministry of Health, Labour and Welfare
Japan
NO
国立病院機構北海道がんセンター(北海道)
札幌医科大学(北海道)
東北大学病院(宮城県)
千葉県がんセンター(千葉県)
国立がん研究センター中央病院(東京都)
日本大学医学部附属板橋病院(東京都)
杏林大学医学部(東京都)
慶應義塾大学病院(東京都)
東京医科歯科大学(東京都)
がん研究会有明病院(東京都)
順天堂大学医学部附属順天堂医院(東京都)
帝京大学医学部(東京都)
横浜市立大学附属病院(神奈川県)
神奈川県立病院機構神奈川県立がんセンター(神奈川県)
新潟県立がんセンター新潟病院(新潟県)
岐阜大学医学部(岐阜県)
静岡県立静岡がんセンター(静岡県)
愛知県がんセンター中央病院(愛知県)
名古屋大学医学部(愛知県)
三重大学医学部(三重県)
京都大学医学部附属病院(京都府)
大阪大学医学部(大阪府)
大阪府立病院機構大阪府立成人病センター(大阪府)
神戸大学医学部(兵庫県)
岡山大学病院(岡山県)
広島大学病院(広島県)
国立病院機構九州がんセンター(福岡県)
久留米大学医学部(福岡県)
九州大学病院(福岡県)
大分大学医学部附属病院(大分県)
2014 | Year | 02 | Month | 17 | Day |
Unpublished
No longer recruiting
2013 | Year | 12 | Month | 13 | Day |
2014 | Year | 01 | Month | 30 | Day |
2014 | Year | 02 | Month | 17 | Day |
2025 | Year | 02 | Month | 17 | Day |
2014 | Year | 02 | Month | 17 | Day |
2021 | Year | 01 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015110
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