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Phase II trial of amrubicin and cisplatin chemotherapy for invasive thymoma

Phase II trial of amrubicin and cisplatin chemotherapy for invasive thymoma - Amrubicin and cisplatin for invasive thymoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003933
Enrollment
40
Registered
2010-08-01
Start date
2010-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

thymoma

Interventions

amrubicin and cisplatin

Sponsors

West Japan Oncology Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Histologically confirmation of invasive recurrent or metastatic thymoma Tumor has measureble lesion as per RECIST (v1.1). ECOG PS 0-1 Adult patient(>20 year of age) No previous chemotherapy and immunotherapy was received At least 4 weeks since prior surgery or radiation therapy. Adequate organ function. White blood cell count >= 4000/mm3 Absolute neutrophil count (ANC)>= 2000/mm3 and platelet count>= 100,000/mm3 Hemoglobin >= 10 gm/Dl Total bilirubin <= 1.5mg/dl AST, ALT must be <= 100IU/L Creatinine <= 1.5 mg/d PaO2 :>=60Torr Thymoma associated paraneoplastic syndrome was clinically controlled.

Exclusion criteria

Exclusion criteria: Other malignancy (exception: non-melanoma skin cancer, cervical carcinoma in situ, cancer without evidence more than 5 years since curative resection) pregnant, or lactating women active bacterial infection Severe, medical condition unstable cardiac disease despite of adequate management myocardial infarction within 6 months. Uncontorllable diabetes mellitus or hypertension or glaucoma. Interstitial lung diesease Active ulcer disease Continuers corticosteroids therapy. Uncontrolled Psychiatric problem which decrease treatment

Design outcomes

Primary

MeasureTime frame
Objective response rate

Secondary

MeasureTime frame
Overall survival, safety

Countries

Japan

Contacts

Public ContactShinichiro Nakamura

West Japan Oncology Group WJOG datacenter

datacenter@wjog.jp06-6633-7400

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026