Study With Trabectedin Versus Adriamycin Plus Dacarbazine, in Patients With Advanced Solitary Fibrous Tumor (STRADA)

February 9, 2024 updated by: Italian Sarcoma Group

Solitary Fibrous Tumor: Phase II Study on Trabectedin Versus Adriamycin Plus Dacarbazine in Advanced Patients

Phase II randomized study for the comparison of trabectedin versus doxorubicin plus dacarbazine in patients with advanced solitary fibrous tumor

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients with solitary fibrous tumor will be randomized to receive 6 cycles of trabectedin or doxorubicin plus dacarbazine.

In case of progression or unacceptable toxicity while under the experimental treatment prior to the completion of the 6 cycles, the patients will be offered to cross to the other arm (trabectedin arm to doxorubicin plus dacarbazine arm and vice versa).

Study Type

Interventional

Enrollment (Estimated)

23

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • IRCCS Istituto Ortopedico Rizzoli
      • Candiolo, Italy, 10060
        • Fondazione Del Piemonte Per L'Oncologia Ircc Di Candiolo -
      • Palermo, Italy
        • Ospedale Giaccone
    • Firenze
      • Prato, Firenze, Italy, 59100
        • Nuovo Ospedale di Prato
    • MI
      • Milano, MI, Italy, 20133
        • Fondazione Irccs Istituto Nazionale Dei Tumori
    • RM
      • Roma, RM, Italy, 00128
        • Policlinico Universitario Campus Biomedico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The patient or legal representative must be able to read and understand the informed consent form (ICF) and must have been willing to give written informed consent and any locally required authorisation before any study-specific procedures, including screening evaluations, sampling, and analyses.
  2. Age ≥18 years
  3. Histological centrally and molecularly confirmed diagnosis of solitary fibrous tumor (inclusive of the last available tumor sample)
  4. Locally advanced disease (i.e. surgical resection of local disease unfeasible radically, or unaccepted by the patient, or amenable to become less demolitive, or feasible, or easier, after cytoreduction) and/or metastatic disease
  5. Measurable or evaluable disease with RECIST
  6. Evidence of progression by RECIST during the 6 months before study entry
  7. Patients must be cytotoxic chemotherapy naïve (patients treated with neoadjuvant/adjuvant chemotherapy cannot be included) or could have received a previous target agent in front-line setting.
  8. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
  9. Adequate bone marrow function
  10. Adequate organ function
  11. Cardiac ejection fraction ≥50% as measured by echocardiogram
  12. Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation each cycle of chemotherapy. Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective method of birth control throughout the study.
  13. No history of arterial and/or venous thromboembolic event within the previous 12 months.

Exclusion Criteria:

  1. Any prior treatment with cytotoxic chemotherapy
  2. >1 line of anticancer targeted agents
  3. Previous treatment with any other investigational or not investigational agents within 14 days of first day of study drug dosing
  4. Previous treatment with radiation therapy within 14 days of first day of study drug dosing, or patients who have not recovered from adverse events due to agents previously administered
  5. Previous radiotherapy to 25 % of the bone marrow
  6. Major surgery within 4 weeks prior to study entry
  7. Other primary malignancy with <5 years clinically assessed disease-free interval, except basal cell skin cancer, cervical carcinoma in situ, or other neoplasms judged to entail a low risk of relapse
  8. Pregnancy or breast feeding
  9. Cardiovascular diseases resulting in a New York Heart Association Functional Status >2 (24). Medical history of a myocardial infarction < 6 months prior to initiation of study treatment
  10. Medical history of arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), or pulmonary embolism within 6 months prior to the initiation of study treatment
  11. Known history of human immunodeficiency virus infection
  12. Active or chronic hepatitis B or C requiring treatment with antiviral therapy
  13. Medical history of hemorrhage or a bleeding event ≥ Grade 3 (NCI-CTCAE v 4.0) within 4 weeks prior to the initiation of study treatment
  14. Evidence of any other serious or unstable illness, or medical, psychological, or social condition, that could jeopardize the safety of the subject and/or his/her compliance with study procedures, or may interfere with the subject's participation in the study or evaluation of the study results
  15. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs
  16. Expected non-compliance to medical regimens

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trabectedin
trabectedin: 1.5 mg/m² - 1.3 mg/m² given in 24-hour continuous infusion every 21 days for 6 cycles
Drug: Trabectedin
Treatment with trabectedin repeated every 21 days for 6 cycles
Experimental: Adriamycin and Dacarbazine
Adriamycin: 75 mg/m2/day, bolus, day 1 every 21 days for 6 cycles Dacarbazine: 400 mg/m2/day, days 1, 2 every 21 days for 6 cycles
Drug: Adriamycin
Treatment with Adriamycin at day 1 every 21 days for 6 cycles
Drug: Dacarbazine
Treatment with Dacarbazine at days 1 and 2 every 21 days for 6 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Tumor Response Rate
Time Frame: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first assessed up to 54 weeks.
evaluate the activity of trabectedin and of adriamycin in combination with dacarbazine, according to Response Evaluation Criteria in Solid Tumor (RECIST), version 1.1
From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first assessed up to 54 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Choi Response Rate
Time Frame: week 6, week 12, week 18, then every 12 weeks up to 54 weeks
Percentage of patient who experienced Complete or Partial Responses after treatment according to Choi Criteria.
week 6, week 12, week 18, then every 12 weeks up to 54 weeks
Overall Survival (OS)
Time Frame: From enrollment up to 5 years
Time from the date of enrollment to date of death
From enrollment up to 5 years
Progression Free Survival (PFS)
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 52 weeks
Survival free of progressive disease evaluated from enrollment up to progression according to RECIST, or death
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks
Clinical Benefit Rate (CBR)
Time Frame: week 6, week 12, week 18, then every 12 weeks up to 54 weeks
Percentage of patients who have achieved complete response, partial response or stable disease ≥ 6 months
week 6, week 12, week 18, then every 12 weeks up to 54 weeks
Response rate by RECIST after the cross over
Time Frame: week 18, week 24, week 30, week 36 and then every 12 weeks up to 54 weeks
Percentage of patient who experienced Complete or Partial Responses according RECIST 1.1 after cross over
week 18, week 24, week 30, week 36 and then every 12 weeks up to 54 weeks
Progression Free Survival (PFS) after cross over up to progression according to RECIST, or death
Time Frame: From date of cross over until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks
Survival free of progressive disease evaluated from
From date of cross over until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks
Safety according to Common Terminology Criteria for Adverse Events (CTCAE)
Time Frame: From enrollment every 3 weeks up to 54 weeks
Safety profile of the treatment evaluated according to Common Terminology Criteria for Adverse Events version 4.03
From enrollment every 3 weeks up to 54 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Italian Sarcoma Group

Investigators

  • Principal Investigator: Silvia Stacchiotti, MD, Italian Sarcoma Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2018

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

December 19, 2016

First Submitted That Met QC Criteria

January 13, 2017

First Posted (Estimated)

January 18, 2017

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISG STRADA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Solitary Fibrous Tumors

Clinical Trials on Trabectedin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe