JCOG2102: Randomized phase III trial of Neo-adjuvant and adjuvant chemotherapy vs Adjuvant Chemotherapy alone for LocalizEd Soft tissue Sarcoma

JRCT ID: jRCTs031220446

Registered date:16/11/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Resectable high grade non-round cell soft tissue sarcoma
• Date of first enrollment: 16/11/2022
• Target sample size: 224
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Overall survival
• Secondary Outcome: Progression-free survival, response rate of preoperative chemotherapy, pathological response rate of preoperative chemotherapy, rate of reduction surgery, rate of extended surgery, postoperative limb function (extremities), proportion of preservation of diseased limb (extremities), adverse events, serious adverse events.

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: <= 70age old
• Gender: Both

Include criteria

(1) Grade 2 or 3 (FNCLCC histological grading system) non-round cell soft-tissue sarcoma with histology of undifferentiated sarcoma (pleomorphic, spindle cell), adult fibrosarcoma, myxofibrosarcoma, leiomyosarcoma, synovial sarcoma, liposarcoma (dedifferentiated, myxoid, pleomorphic), pleomorphic rhabdomyosarcoma, malignant peripheral nerve sheath tumor, angiosarcoma (WHO classification 2020) using open biopsy specimen
(2) 10 or more unstained tumor tissue slides are available
(3) Primary tumor
(4) Tumor in the extremities or trunk
(5) T2-4N0M0 (UICC/AJCC, 8th edition) and deeply seated (localized deeper than the investing fascia, invades the investing fascia, or penetrates the investing fascia) according to the latest imaging studies
(6) Having measurable lesion on MRI axial section
(7) resectable with marginal or wide margin
(8) Age between 16 and 70 years
(9) ECOG Performance status (PS) of 0 or 1
(10) No history of chemotherapy nor radiation therapy for any cancer including NRC-STS
(11) All of the following are met for the most recent laboratory findings within 14 days prior to enrollment:
(i) Neutrophil count >= 1,500/mm3
(ii) Hemoglobin >= 8.0 g/dL (No blood transfusion within 14 days prior to the test used for registration)
(iii) Platelet count >=100,000/mm3
(iv) Total bilirubin <=1.5 mg/dL
(v) AST<=100 U/L
(vi) ALT<=100 U/L
(vii) Serum creatinine<=1.5 mg/dL
(viii) Creatinine clearance >=60 mL/min
(12) The latest ECG within 28 days prior to enrollment shows normal or no changes requiring treatment
(13) Written informed consent

Exclude criteria

(1) Synchronous or metachronous (within 5 years) malignancies except cancer with 5-year relative survival rate of 95% or more
(2) Active infection requiring systemic therapy
(3) Body temperature >= 38 degrees Celsius
(4) Women (possibly) in pregnancy, within 28 days postpartum, or breast feeding. Men who wish to get his partner pregnant
(5) Patients with psychiatric disorders or psychiatric symptoms
(6) Patients requiring systemic steroid medication
(7) Poorly controlled diabetes mellitus or routine administration of insulin
(8) Poorly controlled hypertension
(9) Unstable angina within 3 weeks, or with a history of myocardial infarction
(10) Poorly controlled valvular disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy
(11) Positive HBs antigen

Related Information

• Primary Sponsor: TANAKA Kazuhiro
• Source(s) of Monetary Support: National Cancer Center Japan