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Soft Tissue Sarcoma AdultPhase 3METROPHOLYSNCT04656262

Low Dose Continuous Cyclophosphamide vs Standard Doxorubicin in Advanced Sarcoma Elderly Patients

A Phase 3 study testing Cyclophosphamide and Doxorubicin in people with Soft Tissue Sarcoma Adult, run by Istituto Oncologico Veneto IRCCS at 13 sites in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

To compare the efficacy, as measured by time to treatment failure, of metronomic cyclophosphamide with respect to doxorubicin in elderly patients affected by mSTS. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Soft Tissue Sarcoma Adult
What is being tested?
Cyclophosphamide and Doxorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
13 sitesItaly
Study dates
10 Sep 2018to 23 May 2024
Phase
Phase 3
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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Patients may be included in the study only if they meet all the following criteria:
  • Histologically proven diagnosis of soft tissue sarcoma.
  • Advanced unresectable or metastatic soft tissue sarcoma not previously treated with chemotherapy for metastatic disease.
  • At least one measurable lesion according to RECIST1.1 criteria.
  • Availability of a tumor sample (primary and/or metastatic sites).
  • Age ≥ 70 years (70-75 years if UNFIT at G8; >75 independent of G8 score)
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  • ECOG PS 0-2.
  • Life expectancy of at least 12 weeks.
  • Neutrophils ≥1.5 x 109/L, Platelets ≥100 x 109/L, Hgb ≥ 9 g/dl.
  • Adequate hepatic function, defined as: Total bilirubin ≤ 1.5 time the upper-normal limits (ULN) of the normal values, ASAT (SGOT) and/or ALAT (SGPT) ≤ 2.5 x ULN (or <5 x ULN in case of liver metastases)
  • Alkaline phosphatase ≤ 2.5 x ULN (or <5 x ULN in case of liver metastases).
  • Creatinine clearance ≥ 30 mL/min.
  • Normal cardiac function, with left ventricular ejection fraction (LVEF) ≥50%.
  • Male subjects with female partners of childbearing potential must be willing to use adequate contraception as approved by the investigator
  • Geriatric assessment by means of G8 screening tool and CRASH score.
  • Will and ability to comply with the protocol.
  • Written informed consent to study participation.

Who cannot join

  • Patients will be excluded from the study for any of the following reasons:
  • Previous treatment for metastatic disease.
  • Previous (neo) adjuvant chemotherapy with anthracyclines.
  • Radiotherapy to any site within 4 weeks before the study.
  • Untreated brain metastases or spinal cord compression or primary brain tumors.
  • Active uncontrolled infections or other clinically relevant concomitant illness contraindicating chemotherapy administration.
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  • Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (≤6 months), myocardial infarction (≤6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF), serious cardiac arrhythmia requiring medication.
  • Treatment with any investigational drug within 30 days prior to enrollment or 2 investigational agent half-lives (whichever is longer)
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of localized basal and squamous cell carcinoma or cervical cancer in situ.
  • Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication.
  • Known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs.
  • Any concomitant drugs contraindicated for use with the trial drugs according to the product information of the pharmaceutical companies.
  • Sexually active males unwilling to practice contraception during the study and until 6 months after the last trial treatment.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Italy13 sites

  • Policlinico Sant'Orsola Malpighi

    Bologna, BO, 40138

  • Istituto Ortopedico Rizzoli IRCCS

    Bologna, 40136

  • Fondazione del Piemonte per l'Oncologia IRCCS

    Candiolo, 10060

  • IRST Romagnolo IRCCS

    Meldola, 47014

  • Istituto Nazionale Tumori IRCCS

    Milan, 20133

  • Istituto Oncologico Veneto IRCCS

    Padova, 35128

  • AOU Policlinico Giaccone Palermo

    Palermo, 90127

  • Ospedale Misericordia e Dolce

    Prato, 59100

  • Policlinico Universitario Campus Biomedico

    Roma, 00128

  • IFO - Istituto Regina Elena

    Roma, 00144

  • Istituto Clinico Humanitas

    Rozzano, MI, 20089

  • Presidio Sanitario Humanitas - Gradenico

    Torino, 10153

  • AOUI Policlinico Borgo Roma

    Verona, 37134

Other trials in Italy

About this study

Official title: The METROPHOLYS Study Metronomic Cyclophosphamide vs Doxorubicin in Elderly Patients With Advanced Soft Tissue Sarcomas Randomized, Controlled Open Label Clinical Trial

To compare the efficacy, as measured by time to treatment failure, of metronomic cyclophosphamide with respect to doxorubicin in elderly patients affected by mSTS.

Read the detailed description

This phase III randomized clinical trial was designed to compare metronomic Cyclophosphamide with standard Doxorubicin for the first-line treatment of elderly cancer patients with advanced inoperable or metastatic STS:

  1. ARM A (experimental): Metronomic Cyclophosphamide ii) ARM B (control): Doxorubicin up to six cycles

What participants receive

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

  • CyclophosphamideDrug

    Also called Endoxan

    Cyclophosphamide is formulated as coated tablets of 50mg for oral administration

  • DoxorubicinDrug

    Doxorubicin is formulated as 60 mg/mq for infusional use (i.v use)

Study groups in NCT04656262
Study groupRoleWhat they receive
Metronomic cyclophosphamideExperimentalCyclophosphamide 50 mg daily per os continuously; Patients will be visited for re-cycling every three weeks. Metronomic cyclophosphamide will be taken in the morning along with a full glass of water.
Receives: Drug: Cyclophosphamide
DoxorubicinActive comparatorDoxorubicin 60 mg/mq i.v. in 10 minutes, day 1; to be repeated every three weeks up to a maximum of 6 cycles.
Receives: Drug: Doxorubicin

What is being measured

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

  1. Time to treatment failure

    Progressive disease is defined as per RECIST 1.1 criteria based on investigator assessment.

    Toxicity is assessed according to NCI-CTCAE criteria v. 4.03

    Measured: From date of randomization until the date of treatment discontinuation due to disease progression, toxicity leading to treatment discontinuation, or death, whichever occurs first, assessed up to 12 months

Secondary outcomes (3)

  1. Progression free Survival

    Progressive disease is defined as per RECIST 1.1 criteria based on investigator assessment.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

  2. Overall survival

    Overall Survival is defined as the time from date of randomization to the date of death due to any cause

    Measured: Time from randomization to the date of death due to any cause or last follow up assessed up to 12 months

  3. Overall Toxicity Rate

    Toxicities will be recorded, classified, graded and managed according to NCI CTCAE v. 4.03.

    Measured: From signing IC until 30 days after last study treatment

Timeline

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

  1. First posted7 Dec 2020
  2. Study start10 Sep 2018
  3. Primary completion23 May 2024
  4. Study completion23 May 2024

Why it stopped: enrollment too slow to reach the target in a reasonable time frame

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04656262
Sponsor's protocol ID
IOV-2018-STS-METROPHOLYS
Acronym
METROPHOLYS
Status last verified
Jul 2024
First submitted
25 Nov 2020
Last updated
8 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cyclophosphamide and Doxorubicin in people with Soft Tissue Sarcoma Adult, run by Istituto Oncologico Veneto IRCCS at 13 sites in Italy.

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 17 inclusion and 13 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: stopped early, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study was stopped early (reason given: enrollment too slow to reach the target in a reasonable time frame). 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?

Time to treatment failure (time frame: From date of randomization until the date of treatment discontinuation due to disease progression, toxicity leading to treatment discontinuation, or death, whichever occurs first, assessed up to 12 months). 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 NCT04656262.

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 8 Jul 2024.

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