Malignant Soft Tissue Sarcoma Clinical Trial
Official title:
The Use of Propranolol Hydrochloride Combined With Anthracyclin Based Chemotherapy in the Treatment of Metastatic Soft Tissue Sarcoma
| Verified date | February 2018 |
| Source | Ain Shams University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Not yet recruiting |
| Enrollment | 50 |
| Est. completion date | August 30, 2021 |
| Est. primary completion date | August 30, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Ain Shams University |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression Free Survival | Progression free survival (PFS) is defined as the time interval between the dates of first treatment administration and first observation of PD. | an average of 1 year | |
| Secondary | Overall Survival | 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. | an average of 3 years |