UMIN-CTR Clinical Trial

Basic information
Public 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)
Acronym	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)
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)
Scientific Title:Acronym	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)
Region	Japan

Condition
Condition	soft tissue sarcoma
Classification by specialty	Orthopedics
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II,III

Assessment
Primary outcomes	PhaseII: Proportion of completion of preoperative chemotherapy without progression disease. Phase III: Overall survival
Key secondary outcomes	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.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	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
Interventions/Control_2	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
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	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.
Key exclusion criteria	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
Target sample size	140

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yukihide Iwamoto, MD, PhD roll: Study Chair
Organization	Kyushu University Hospital
Division name	Department of Orthopaedic Surgery
Zip code
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, JAPAN
TEL	092-642-5488(81-92-642-5488)
Email	yiwamoto@ortho.med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kazuhiro Tanaka, MD, PhD
Organization	JCOG1306 Coordinating Office
Division name	Department of Orthopaedic Surgery, Oita University Hospital
Zip code
Address	1-1, Idaigaoka, Hasamamachi, Yuhu city, Oita, 879-5593, JAPAN
TEL	097-586-5872(81-97-586-5872)
Homepage URL	http://www.jcog.jp/
Email	JCOG_sir@ml.jcog.jp

Sponsor
Institute	Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions

Institutions

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）

Other administrative information
Date of disclosure of the study information	2014 Year 02 Month 17 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 12 Month 13 Day
Date of IRB	2014 Year 01 Month 30 Day
Anticipated trial start date	2014 Year 02 Month 17 Day
Last follow-up date	2025 Year 02 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 02 Month 17 Day
Last modified on	2021 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015110