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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04656262
Recruitment Status : Recruiting
First Posted : December 7, 2020
Last Update Posted : December 7, 2020
Sponsor:
Collaborator:
Ministry of Health, Italy
Information provided by (Responsible Party):
Istituto Oncologico Veneto IRCCS

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma Adult Drug: Cyclophosphamide Drug: Doxorubicin Phase 3

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:

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The METROPHOLYS Study Metronomic Cyclophosphamide vs Doxorubicin in Elderly Patients With Advanced Soft Tissue Sarcomas Randomized, Controlled Open Label Clinical Trial
Actual Study Start Date : September 10, 2018
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Metronomic cyclophosphamide
Cyclophosphamide 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.
 Drug: Cyclophosphamide
Cyclophosphamide is formulated as coated tablets of 50mg for oral administration
Other Name: Endoxan
Active Comparator: Doxorubicin
Doxorubicin 60 mg/mq i.v. in 10 minutes, day 1; to be repeated every three weeks up to a maximum of 6 cycles.
 Drug: Doxorubicin
Doxorubicin is formulated as 60 mg/mq for infusional use (i.v use)


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

    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



Secondary Outcome Measures :
  1. Progression free Survival [ Time Frame: 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 ]
    Progressive disease is defined as per RECIST 1.1 criteria based on investigator assessment.

  2. Overall survival [ Time Frame: Time from randomization to the date of death due to any cause or last follow up assessed up to 12 months ]
    Overall Survival is defined as the time from date of randomization to the date of death due to any cause

  3. Overall Toxicity Rate [ Time Frame: From signing IC until 30 days after last study treatment ]
    Toxicities will be recorded, classified, graded and managed according to NCI CTCAE v. 4.03.


Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients may be included in the study only if they meet all the following criteria:

  1. Histologically proven diagnosis of soft tissue sarcoma.
  2. Advanced unresectable or metastatic soft tissue sarcoma not previously treated with chemotherapy for metastatic disease.
  3. At least one measurable lesion according to RECIST1.1 criteria.
  4. Availability of a tumor sample (primary and/or metastatic sites).
  5. Age ≥ 70 years (70-75 years if UNFIT at G8; >75 independent of G8 score)
  6. ECOG PS 0-2.
  7. Life expectancy of at least 12 weeks.
  8. Neutrophils ≥1.5 x 109/L, Platelets ≥100 x 109/L, Hgb ≥ 9 g/dl.
  9. 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)
  10. Alkaline phosphatase ≤ 2.5 x ULN (or <5 x ULN in case of liver metastases).
  11. Creatinine clearance ≥ 30 mL/min.
  12. Normal cardiac function, with left ventricular ejection fraction (LVEF) ≥50%.
  13. Male subjects with female partners of childbearing potential must be willing to use adequate contraception as approved by the investigator
  14. Geriatric assessment by means of G8 screening tool and CRASH score.
  15. Will and ability to comply with the protocol.
  16. Written informed consent to study participation.

Exclusion Criteria:

  • Patients will be excluded from the study for any of the following reasons:

    1. Previous treatment for metastatic disease.
    2. Previous (neo) adjuvant chemotherapy with anthracyclines.
    3. Radiotherapy to any site within 4 weeks before the study.
    4. Untreated brain metastases or spinal cord compression or primary brain tumors.
    5. Active uncontrolled infections or other clinically relevant concomitant illness contraindicating chemotherapy administration.
    6. 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.
    7. Treatment with any investigational drug within 30 days prior to enrollment or 2 investigational agent half-lives (whichever is longer)
    8. 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.
    9. Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication.
    10. Known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs.
    11. Any concomitant drugs contraindicated for use with the trial drugs according to the product information of the pharmaceutical companies.
    12. Sexually active males unwilling to practice contraception during the study and until 6 months after the last trial treatment.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04656262


Contacts
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Contact: Gian Luca De Salvo 0039-049-8215710 gianluca.desalvo@iov.veneto.it

Locations
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Italy
Policlinico Sant'Orsola Malpighi Recruiting
Bologna, BO, Italy, 40138
Contact: Margherita Nannini, MD         
Istituto Clinico Humanitas Recruiting
Rozzano, MI, Italy, 20089
Contact: Andrea Marrari, MD         
Istituto Ortopedico Rizzoli IRCCS Not yet recruiting
Bologna, Italy, 40136
Contact: Emanuela Palmerini, MD         
Fondazione del Piemonte per l'Oncologia IRCCS Not yet recruiting
Candiolo, Italy, 10060
Contact: Giovanni Grignani, MD         
IRST Romagnolo IRCCS Recruiting
Meldola, Italy, 47014
Contact: Toni Ibrahim, MD         
Istituto Nazionale Tumori IRCCS Not yet recruiting
Milano, Italy, 20133
Contact: Silvia Stracchiotti, MD         
Istituto Oncologico Veneto IRCCS Recruiting
Padova, Italy, 35128
Contact: Antonella Brunello, PhD         
AOU Policlinico Giaccone Palermo Not yet recruiting
Palermo, Italy, 90127
Contact: Giuseppe Badalamenti, MD         
Ospedale Misericordia e Dolce Not yet recruiting
Prato, Italy, 59100
Contact: Giacomo GI Baldi, MD         
Policlinico Universitario Campus Biomedico Recruiting
Roma, Italy, 00128
Contact: Bruno Vincenzi, MD         
IFO - Istituto Regina Elena Not yet recruiting
Roma, Italy, 00144
Contact: Virginia Ferraresi, MD         
Presidio Sanitario Humanitas - Gradenico Not yet recruiting
Torino, Italy, 10153
Contact: Alessandro Comandone, MD         
AOUI Policlinico Borgo Roma Recruiting
Verona, Italy, 37134
Contact: Sara Cingarlini, MD         
Sponsors and Collaborators
Istituto Oncologico Veneto IRCCS
Ministry of Health, Italy
Investigators
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Principal Investigator: Antonella Brunello Istituto Oncologico Veneto
More Information
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Responsible Party: Istituto Oncologico Veneto IRCCS
ClinicalTrials.gov Identifier: NCT04656262    
Other Study ID Numbers: IOV-2018-STS-METROPHOLYS
First Posted: December 7, 2020    Key Record Dates
Last Update Posted: December 7, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Cyclophosphamide
Doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
 Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors