Use of Propranolol Hydrochloride in the Treatment of Metastatic STS

Phase 2

• Conditions: Malignant Soft Tissue Sarcoma
• Interventions: Drug: Propranolol Hydrochloride; Drug: Doxorubicin

• Registration Number: NCT03108300
• Lead Sponsor: Ain Shams University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-16
• Study First Submitted QC: 2017-04-05
• Study First Posted: 2017-04-11
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-22
• Last Update Posted: 2018-02-23
• Study Start: 2019-08-30
• Primary Completion: 2020-08-30
• Study Completion: 2021-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
propranolol hydrochloride with Doxorubicin	Propranolol Hydrochloride	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
propranolol hydrochloride with Doxorubicin	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.