Clinical trial · Interventional

Use of Propranolol Hydrochloride in the Treatment of Metastatic STS

The Use of Propranolol Hydrochloride Combined With Anthracyclin Based Chemotherapy in the Treatment of Metastatic Soft Tissue Sarcoma

NCT03108300CI-TRIAL-00031779unknownPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Malignant Soft Tissue Sarcoma	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Doxorubicin	Drug	Doxorubicin	ALIAS
Propranolol Hydrochloride	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
propranolol hydrochloride with Doxorubicin
description
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
interventionNames
1. Drug: Propranolol Hydrochloride
2. Drug: Doxorubicin

Primary outcomes (1)

measure
Progression Free Survival
timeFrame
an average of 1 year
description
Progression free survival (PFS) is defined as the time interval between the dates of first treatment administration and first observation of PD.

Secondary outcomes (1)

measure
Overall Survival

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 19 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

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