Status:
WITHDRAWN
Pegylated Liposomal Doxorubicin Versus Pirarubicin Plus Ifosfamide, Dacarbazine in Locally Advanced, Unresectable or Metastatic Soft-tissue Sarcoma
Lead Sponsor:
Peking University People's Hospital
Collaborating Sponsors:
Peking University Shougang Hospital
Chinese PLA General Hospital
Conditions:
Progression-free Survival
Overall Survival
Eligibility:
All Genders
16+ years
Phase:
PHASE2
PHASE3
Brief Summary
Advanced soft tissue sarcoma patients who have previously recieved anthracyclines might still benefit from doxorubicin, ifosfamide and dacarbazine. However doxorubicin might be stopped using because o...
Detailed Description
We design this multicentre, open-label, randomised, phase 2 trial at 5 academic hospitals in China. Eligible patients need to be aged 16 years or older with a diagnosis of an advanced unresectable or ...
Eligibility Criteria
Inclusion
- 16 years or older;
- diagnosis of an advanced unresectable or metastatic soft tissue sarcoma, of intermediate or high grade, for which no standard curative therapy is available;
- cumulative dose of anthracycline antibiotic ≥ 300mg/m2;
- stable or responsive to doxorubicin, potential beneficiary;
- an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, a life expectancy of at least 3 months;
- measurable disease according to RECIST 1.1;
- adequate end-organ and haemopoietic function.
Exclusion
- progress over doxorubicin;
- previous mediastinal or cardiac radiotherapy;
- a low-grade tumour according to standard grading systems (eg, American Joint Committee on Cancer grade 1 and 2 or Fédération Nationale des Centres de Lutte Contre le Cancer grade 1);
- significant cardiac dysfunction;
- severe chronic obstructive pulmonary disease;
- a known infection with HIV or active infection with hepatitis B or hepatitis C;
- known brain metastases unless previously treated and well controlled for a period of 3 months or longer;
- combination with other anti-tumor therapy;
- pregnant or breastfeeding.
Key Trial Info
Start Date :
November 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03342300
Start Date
November 6 2017
End Date
December 30 2020
Last Update
May 19 2020
Active Locations (1)
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1
Peking University People's Hospital
Beijing, China, 100044