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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03108300

Enrollment

Registered

2017-04-11

Start date

2019-08-30

Completion date

2021-08-30

Last updated

2018-02-23

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

Conditions

Malignant Soft Tissue Sarcoma

Keywords

efficacy, propranolol hydrochloride, sts

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

Interventions

DRUGPropranolol Hydrochloride

propranolol hydrochloride is a beta-adrenergic receptor blocker

DRUGDoxorubicin

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Histologic or cytologic diagnosis of malignant soft tissue sarcoma. 2. ECOG less than or equal to 2 . 3. Measurable disease according to the requirements of modified RECIST criteria. 4. Age ≥ 19 years . 5. Estimated life expectancy of at least 12 weeks . 6. 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).

Exclusion criteria

1. 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). 2. Inadequate renal function (creatinine \> 1.25 times UNL, creatinine clearance \< 50mL/min). 3. Serious concomitant systemic disorder incompatible with the study. 4. 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). 5. Pregnancy

Design outcomes

Primary

Measure	Time frame	Description
Progression Free Survival	an average of 1 year	Progression free survival (PFS) is defined as the time interval between the dates of first treatment administration and first observation of PD.

Secondary

Measure	Time frame	Description
Overall Survival	an average of 3 years	Overall Survival (OS) is defined as the time from the date of the first treatment administration to the date of death due to any cause.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026