JCOG1306:Randomized phase II/III study of adjuvant chemotherapy with Adriamycin+Ifosfamide vs Gemcitabine+Docetaxel for high-grade soft tissue sarcoma ( AI vs GD for STS RPII/III )

Phase 2

• Conditions: soft tissue sarcoma

• Registration Number: JPRN-jRCTs031180003
• Lead Sponsor: Ozaki Toshifumi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

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 sheath 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) UICC/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.

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase II: Proportion of completion of preoperative chemotherapy without progression disease. <br>Phase III: Overall survival

Secondary Outcome Measures

Name	Time	Method
Phase II/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.