UnknownPhase 2

Use of Propranolol Hydrochloride in the Treatment of Metastatic STS

50 participantsStarted 2019-08-30

Plain-language 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

Who can participate

Age range19 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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).

Exclusion criteria

✕. 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

What they're measuring

Progression Free Survival

Timeframe: an average of 1 year

Trial details

NCT IDNCT03108300

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-08-30

View on ClinicalTrials.gov More Malignant Soft Tissue Sarcoma trials