Use of Propranolol Hydrochloride in the Treatment of Metastatic STS

Overview

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

Full Title of Study: “The Use of Propranolol Hydrochloride Combined With Anthracyclin Based Chemotherapy in the Treatment of Metastatic Soft Tissue Sarcoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 30, 2020

Interventions

  • Drug: Propranolol Hydrochloride
    • propranolol hydrochloride is a beta-adrenergic receptor blocker
  • Drug: Doxorubicin
    • 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

Arms, Groups and Cohorts

  • Experimental: propranolol hydrochloride with Doxorubicin
    • The 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

Clinical Trial Outcome Measures

Primary Measures

  • Progression Free Survival
    • Time Frame: 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 Measures

  • Overall Survival
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ain Shams University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ahmed Nagy, Principal Investigator – Ain Shams University

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