JCOG1802: A randomized phase II trial of 2nd line treatment for advanced soft tissue sarcoma comparing trabectedin, eribulin and pazopanib

JRCT ID: jRCTs031190152

Registered date:05/12/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Advanced soft tissue sarcoma
• Date of first enrollment: 06/01/2020
• Target sample size: 120
• Study type: Interventional

Intervention(s)

Arm A: intravenous drip infusion of Trabectedin 1.2 mg/m2 (body surface area) on day 1 for 24 hours every 3 weeks.
Arm B: intravenous drip infusion of Eribulin 1.4 mg/m2 (body surface area) on day 1 and 8 for 2-5 minutes every 3 weeks.
Arm C: take Pazopanib 800 mg/day orally more than 1 hour before meals or more than 2 hours after meals every day.

Outcome(s)

• Primary Outcome: progression-free survival
• Secondary Outcome: overall survival, disease control rate, response rate, proportions of adverse events (adverse reactions)

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Histologically proven soft tissue sarcoma
(2) H&E slides used for diagnosis of (1) are available
(3) Soft tissue sarcoma with metastatic disease (Stage IV in AJCC- TNM 8th edition), unresectable primary sarcoma, or unresectable recurrent sarcoma
(4) Disease progression confirmed within 6 months
(5) Disease to fulfill either following (i)-(iv), chemotherapy including perioperative chemotherapy
(i) Disease progression (local progression or metaetatsis) after chemotherapy including doxorubicin
(ii) Disease progression after termination of chemotherapy including doxorubicin because of other than disease progression
(iii) Reccurence of disease which is disappeared by chemotherapy including doxorubicin (local and distant recurrence)
(iv) Disease progression of residual disease after chemotherapy including doxorubicin
(6) History of chemotherapy for sarcoma is only regimen including doxorubicin
(7) No treatment history for sarcoma and other cancers with trabectedin, eribulin or pazopanib
(8) Age 16 years or older
(9)ECOG status (PS): 0-2
(10) Measurable or non-measurable disease
(11) Adequate oral intake
(12)Latest adequate organ function as proved by the following laboratory studies within 14 days prior to registration
[1] Nutrophil count>=1,500 /mm3
[2] Hemoglobin>=8.0 g/dL
[3] Platelet count>=100,000 /mm3
[4] Total bilirubin<=1.5 mg/dL
[5] AST<=100 U/L
[6] ALT<=100 U/L
[7] Renal function to fulfill either following (a) or (b),
(a) Creatinine<=1.5 mg/dL
(b) Creatinine clearance>=50 mL/min
[8] ALP<=900 U/L (JSCC method), ALP<=315 U/L (IFCC method)
[9] CPK,=600 U/L for men, <=400 U/L for woman
[10] PT-INR<=1.38
[11] APTT<=44.4 sec
[12] TSH: 0.5-4.5 micro U/mL
[13] FT4: 0.9-1.8 ng/dL
(13) Normal findings or no need of treatment in case of abnormal findings on electrocardiogram (ECG) within 28 days prior to registration
(14) Ejection fraction of cardiac ultrasound examination: more than 50% within 28 days prior to registration
(15) Written informed consent (If the patient's age is under 20 years old, the additional consent must be obtained from the patient's parent or legal guardian.)

Exclude criteria

(1) Synchronous or metachronous (within 2 years) malignancy except cancer with 2-year relative survival rate of 95% or more
(2) Diagnosed with active infectious disease requiring systemic treatment
(3) Febrile more than 38 degrees Celsius at the registation
(4) Pregnancy, possible pregnancy, within 28 days after delivery or breast-feeding. Male subjects who want pregnancy of their partner
(5) Psychological disorder difficult to participate in this clinical study
(6) Receiving continuous systemic corticosteroid or immunesuppressant treatment (systemically or intravenously)
(7)Systolic blood pressure>140 mmHg and diastolic blood pressure>90 mmHg two consecutive times measured in a hospital on the day of registration (irrespective of antihypertensive agents use)
(8) Interstitial pneumonia , pulmonary fibrosis or severe emphysema based on chest CT
(9) HBs antigen positive
(10) History of cardiovascular disease
[1] Myocardial infarction within the last 6 months, unstable angina pectoris within the last 3 weeks
[2] Angioplasty surgery or stent implantation, or coronary artery bypass graft within 6 months
[3] Heart failure class III or IV accorging to NYHA
[4] Uncontrolled valve disease, dilative cardiomyopathy, or hypertrophic myocardiopathy
(11) Active bleeding
(12) Symptomatic brain metastasis or brain metastasis requiring treatment (screening of brain metastasis is not required for clinically unnecessary patients)
(13) Pleural effusion, ascitic fluid, pericardial effusion requiring drainage

Related Information

• Primary Sponsor: TANAKA Kazuhiro
• Source(s) of Monetary Support: National Cancer Center Japan,Japan Agency for Medical Research and Development