Pegylated Liposomal Doxorubicin Versus Pirarubicin Plus Ifosfamide, Dacarbazine in Locally Advanced, Unresectable or Metastatic Soft-tissue Sarcoma (PDVPSTS)
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|ClinicalTrials.gov Identifier: NCT03342300|
Recruitment Status : Recruiting
First Posted : November 14, 2017
Last Update Posted : November 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Progression-free Survival Overall Survival Toxicity||Drug: pegylated liposomal doxorubicin Drug: pirarubicin||Phase 2 Phase 3|
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 metastatic soft-tissue sarcoma, of intermediate or high grade, for which no standard curative therapy will be available, an Eastern Cooperative Oncology Group performance status of 0-1, and measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1.
Participants will be randomly assigned (1:1) to receive pegylated liposomal doxorubicin (60 mg/m² via continuous intravenous infusion for 4-6 h on day 1 of every 21-day cycle for up to six cycles) or pirarubicin (30 mg/m2/d continuous intravenous infusion for 3h on day 1 and 2 of every 21-day cycle for up to six cycles) plus ifosfamide ( 2 g/m²/d intravenously for 2h on day 2,3 and 4 of every 21-day cycle for up to six cycles), dacarbazine (300 mg/m²/d intravenously for 2h on day 2,3 and 4 of every 21-day cycle for up to six cycles ).After six cycles of treatment, patients will be followed up expectantly whereas patients with stable or responsive disease are allowed to continue with ifosfamide and dacarbzine until documented disease progression. A web-based central randomisation with block sizes of two and four was stratified by extent of disease, drug administration method, and previous systemic therapy. Patients and investigators will not be masked to treatment assignment. The primary endpoint is progression survival, analysed in the intention-to-treat population. Safety analyses will be done in all patients who receive any amount of study drug.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients will be randomly assigned (1:1) to receive pegylated liposomal doxorubicin (50 mg/m² on day 1 of every 21-day cycle for up to six cycles) or pirarubicin (60 mg/m² on day 1 of every 21-day cycle for up to six cycles) plus ifosfamide (2 g/m²/d d2-4 of every 21-day cycle for up to six cycles) and dacarbazine (300 mg/m²/d d2-4 of every 21-day cycle for up to six cycles).|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||A web-based central randomisation with block sizes of two and four was stratified by extent of disease,anthracycline administration method, and previous systemic therapy. Participants and investigators will not be masked to treatment assignment. The primary endpoint will be assessed in the intention-to-treat population. The outcome assessors will be masked to the two research groups.|
|Official Title:||Comparing the Effectiveness and Toxicity for Locally Advanced, Unresectable or Metastatic Soft-tissue Sarcoma Patients Who Had Received Total Dose of Anthracycline Antibiotics More Than 300mg/m2 With Pegylated Liposomal Doxorubicin Versus Pirarubicin Plus Ifosfamide, Dacarbazine, a Multicentre, Open-label, Randomised Phase 2 Trial|
|Actual Study Start Date :||November 6, 2017|
|Estimated Primary Completion Date :||November 15, 2019|
|Estimated Study Completion Date :||December 30, 2019|
Experimental: Arm A
participants will recieve pegylated liposomal doxorubicin (50 mg/m²d1) plus ifosfamide (2 g/m²/d d2-3), dacarbazine (300 mg/m²/d d2-3).
Drug: pegylated liposomal doxorubicin
Several efforts have been made to improve the toxicity profile of conventional anthracyclines, including the use of liposomal encapsulation technology,such as pegylated liposomal doxorubicin.
Placebo Comparator: Arm B
participants will recieve pirarubicin (60 mg/m²d1) plus ifosfamide (2 g/m²/d d2-3), dacarbazine (300 mg/m²/d d2-3).
Another effort has been made to improve the toxicity profile of conventional anthracyclines is the development of novel anthracycline analogs,such as pirarubicin.
- progression-free survival [ Time Frame: 12 weeks ]Progression-free survival is defined as time from randomisation to the first occurrence of progression of disease or death from any cause within 63 days of last response assessment or randomisation.
- overall survival [ Time Frame: 12 months ]overall survival is defined as the duration from date of randomisation to the date of death from any cause.
- objective response rate, ORR [ Time Frame: 12 weeks ]objective response rate includes complete and partial responses as defined by RECIST version 1.1.
- left ventricular ejection fraction function [ Time Frame: 12 months ]We use ultrasound to routinely estimate the left ventricular ejection fraction function.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342300
|Contact: Lu Xie, M.D.||+firstname.lastname@example.org|
|Contact: Jie Xu, M.D.||+email@example.com|
|Peking University People's Hospital||Recruiting|
|Beijing, China, 100044|
|Contact: Tingting Ren, Ph.D. +86-13810095026 firstname.lastname@example.org|
|Principal Investigator: Wei Guo, M.D. and Ph.D.|
|Principal Investigator:||Wei Guo, M.D.and Ph.D.||Musculoskeletal Tumor Center of Peking University People's Hospital|