Use of Propranolol Hydrochloride in the Treatment of Metastatic STS
The Use of Propranolol Hydrochloride Combined With Anthracyclin Based Chemotherapy in the Treatment of Metastatic Soft Tissue Sarcoma
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
Fifty patients with pathological proof of malignant soft tissue sarcoma will receive Anthracyclin based chemotherapy combined with propranolol 40 mg twice daily.
- The primary end point : To assess Progression Free Survival (PFS)
- The secondary end points : To assess Overall Survival (OS) and Toxicity Profile
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2017
CompletedFirst Posted
Study publicly available on registry
April 11, 2017
CompletedStudy Start
First participant enrolled
August 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2021
CompletedFebruary 23, 2018
February 1, 2018
1 year
March 16, 2017
February 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
Progression free survival (PFS) is defined as the time interval between the dates of first treatment administration and first observation of PD.
an average of 1 year
Secondary Outcomes (1)
Overall Survival
an average of 3 years
Study Arms (1)
propranolol hydrochloride with Doxorubicin
EXPERIMENTALThe patients suffering from metastatic soft tissue sarcoma will receive doxorubicin 60mg per square meter of body surface area every 21 days combined with propranolol hydrochloride 40mg twice daily
Interventions
propranolol hydrochloride is a beta-adrenergic receptor blocker
Doxorubicin is a chemotherapy which will be injected by a dose 60 mg per meter square of body surface area to be repeated every 21days
Eligibility Criteria
You may qualify if:
- Histologic or cytologic diagnosis of malignant soft tissue sarcoma.
- ECOG less than or equal to 2 .
- Measurable disease according to the requirements of modified RECIST criteria.
- Age ≥ 19 years .
- Estimated life expectancy of at least 12 weeks .
- Adequate bone marrow reserve (white blood cells \[WBC\] ≥ 3.5 × 109 /L, neutrophils ≥ 1.5 × 109 /L, platelets ≥ 100 × 109 /L, and hemoglobin ≥ 9.0 gm/dL).
You may not qualify if:
- Inadequate liver function (bilirubin \> 1.5 times upper normal limit \[UNL\] and alanine transaminase \[ALT\] or aspartate transaminase \[AST\] \> 3.0 UNL or up to 5.0 UNL in the presence of hepatic metastases).
- Inadequate renal function (creatinine \> 1.25 times UNL, creatinine clearance \< 50mL/min).
- Serious concomitant systemic disorder incompatible with the study.
- Second primary malignancy (except in situ carcinoma of the cervix, adequately treated basal cell carcinoma of the skin, T1 vocal cord cancer in remission, or prior malignancy treated more than 5 years prior to enrollment without recurrence).
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 16, 2017
First Posted
April 11, 2017
Study Start
August 30, 2019
Primary Completion
August 30, 2020
Study Completion
August 30, 2021
Last Updated
February 23, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share