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 )

JRCT ID: jRCTs031180003

Registered date:22/01/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: soft tissue sarcoma
• Date of first enrollment: 22/01/2019
• Target sample size: 140
• Study type: Interventional

Intervention(s)

A: Three courses of preoperative chemotherapy with adriamycin (30mg/m2/day, day 1-2) and ifosfamide (2g/m2/day, day 1-5) every three weeks followed by surgical resection and two courses of postoperative chemotherapy after that
B: Three courses of preoperative chemotherapy with gemcitabine (900mg/m2/day, day 1,8) and docetaxel (70mg/m2/day, day 8) every three weeks followed by surgical resection and two courses of postoperative chemotherapy after that

Outcome(s)

Primary Outcome

Phase II: Proportion of completion of preoperative chemotherapy without progression disease.
Phase III: Overall survival

• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 70age old
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Ozaki Toshifumi
• Source(s) of Monetary Support: National Cancer Center Japan,Ministry of Health, Labour and Welfare,Japan Agency for Medical Research and Development
• Secondary ID(s): UMIN000013175