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Malignant Soft Tissue SarcomaPhase 2NCT03108300

Use of Propranolol Hydrochloride in the Treatment of Metastatic STS

A Phase 2 study testing Propranolol Hydrochloride and Doxorubicin in people with Malignant Soft Tissue Sarcoma, run by Ain Shams University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Malignant Soft Tissue Sarcoma
What is being tested?
Propranolol Hydrochloride and Doxorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
30 Aug 2019to 30 Aug 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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

About this study

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

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
Being tested
Propranolol Hydrochloride, Doxorubicin
Keywords
efficacy, propranolol hydrochloride, sts
Medical subject headings
Ichthyosis, X-Linked

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Propranolol HydrochlorideDrug

    propranolol hydrochloride is a beta-adrenergic receptor blocker

  • DoxorubicinDrug

    Also called Adriamycin

    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

Study groups in NCT03108300
Study groupRoleWhat they receive
propranolol hydrochloride with DoxorubicinExperimentalThe 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
Receives: Drug: Propranolol Hydrochloride; Drug: Doxorubicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: an average of 1 year

Secondary outcomes (1)

  1. 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.

    Measured: an average of 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2017
  2. Study start30 Aug 2019 (estimated)
  3. Primary completion30 Aug 2020 (estimated)
  4. Study completion30 Aug 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03108300
Sponsor's protocol ID
CURE002
Status last verified
Feb 2018
First submitted
16 Mar 2017
Last updated
23 Feb 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Propranolol Hydrochloride and Doxorubicin in people with Malignant Soft Tissue Sarcoma, run by Ain Shams University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03108300.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018.

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