Use of Propranolol Hydrochloride in the Treatment of Metastatic STS

NCT ID: NCT03108300

Last Updated: 2018-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-30
• Study Completion Date: 2021-08-30

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

Conditions

Malignant Soft Tissue Sarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Propranolol Hydrochloride

Intervention Type: DRUG

propranolol hydrochloride is a beta-adrenergic receptor blocker

Doxorubicin

Intervention Type: DRUG

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

Interventions

Propranolol Hydrochloride

propranolol hydrochloride is a beta-adrenergic receptor blocker

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Adriamycin

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Nagy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

CURE002

Identifier Type: -

Identifier Source: org_study_id