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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000013175
Receipt No. 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

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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