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SarcomaPhase 3NCT00796120

An Efficacy and Safety Study of Trabectedin Versus Doxorubicin-Based Chemotherapy in Participants With Translocation-Related Sarcomas (TRS)

A Phase 3 study testing Trabectedin, Doxorubicin and Ifosfamide in people with Sarcoma, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 21 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy and safety of trabectedin compared to standard doxorubicin in participants with advanced translocation-related sarcomas (cancer of connective tissue cells) (TRS). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoma
What is being tested?
Trabectedin, Doxorubicin and Ifosfamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
21 sitesin 5 countries
Study dates
Nov 2008to Aug 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Pathological diagnosis of translocation-related sarcomas (TRS) including the following subtypes: alveolar soft part sarcoma, angiomatoid fibrous histiocytoma, clear cell sarcoma, desmoplastic small round cell tumor, low grade endometrial stromal sarcoma (prior hormone therapy allowed), low grade fibromyxoid sarcoma, myxoid chondrosarcoma, myxoid/round cell liposarcoma (MRCL) and synovial sarcoma
  • Participants must have unresectable locally advanced or metastatic progressive disease prior to enrolment
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2
  • Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) within normal limits according to institutional standards, as shown by echocardiography or scintigraphy multiple-gated acquisition scan [MUGA]
  • Measurable disease as defined by the radiological (computed tomography [CT] scan and magnetic resonance imaging [MRI]) Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) guidelines

Who cannot join

  • Known hypersensitivity to any components of the intravenous formulation of trabectedin or the comparators
  • Prior chemotherapy treatment or irradiation of the lesion if only one target lesion is available
  • Brain metastases and/or leptomeningeal metastases, even if treated
  • Pregnant or lactating women or men and women of reproductive potential who are not using effective contraceptive methods
  • History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for five years or more

Trial locations and contacts

21 sites in 5 countries.

21 sites in 5 countries

United States6 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Boston, Massachusetts

  • Study site

    Houston, Texas

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Salt Lake City, Utah

  • Study site

    Santa Monica, California

Other trials in United States

France5 sites

  • Study site

    Boreaux

  • Study site

    Lille

  • Study site

    Lyon

  • Study site

    Paris

  • Study site

    Villejuif

Other trials in France

United Kingdom4 sites

  • Study site

    Edinburgh

  • Study site

    Glasgow

  • Study site

    London

  • Study site

    Manchester

Other trials in United Kingdom

Germany3 sites

  • Study site

    Bad Saarow

  • Study site

    Cologne

  • Study site

    Mannheim

Other trials in Germany

Spain3 sites

  • Study site

    Barcelona

  • Study site

    Palma

  • Study site

    Valencia

Other trials in Spain

About this study

Official title: A Randomized, Multicenter, Phase III Trial of Trabectedin (Yondelis) Versus Doxorubicin-based Chemotherapy as First-Line Therapy in Patients With Translocation-Related Sarcomas (TRS)

The purpose of this study is to evaluate the efficacy and safety of trabectedin compared to standard doxorubicin in participants with advanced translocation-related sarcomas (cancer of connective tissue cells) (TRS).

Read the detailed description

This is a randomized (study drug assigned by chance), multicenter (when more than one hospital or medical school team work on a medical research study), Phase 3 trial to evaluate the efficacy and safety of trabectedin as compared to standard doxorubicin in participants with advanced TRS. Participants will be randomized in a 1:1 ratio to either of the 2 treatment groups, that is, trabectedin or doxorubicin plus ifosfamide group. Participants in trabectedin group will receive trabectedin 1.5 milligram per square meter (mg/m^2) given as a 24-hour continuous intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) every 3 weeks and in doxorubicin plus ifosfamide group participants will receive doxorubicin 60 or 75 mg/m^2 intravenously every 3 weeks followed by ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks. Participants in either treatment arm will continue receiving therapy in the absence of progressive disease (PD) or intolerable side effects, until the participants' consent is withdrawn or the eligibility criteria for continuing treatment are no longer fulfilled, or when a concurrent condition precludes continuation of treatment. Efficacy will be assessed primarily by evaluating progression-free survival (PFS). Participants' safety will be monitored throughout the trial.

Conditions
Sarcoma
Being tested
Trabectedin, Doxorubicin, Ifosfamide
Keywords
Sarcomas, Trabectedin, Doxorubicin, Ifosfamide, YONDELIS
Medical subject headings
Sarcoma

What participants receive

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

  • TrabectedinDrug

    Trabectedin 1.5 milligram per square meter (mg/m^2) will be given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.

  • DoxorubicinDrug

    Doxorubicin 60 or 75 mg/m^2 will be given intravenously every 3 weeks until disease progression.

  • IfosfamideDrug

    Ifosfamide 6 to 9 g/m^2 will be given intravenously every 3 weeks until disease progression.

Study groups in NCT00796120
Study groupRoleWhat they receive
TrabectedinExperimentalTrabectedin 1.5 milligram per square meter (mg/m^2) will be given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
Receives: Drug: Trabectedin
Doxorubicin plus IfosfamideActive comparatorDoxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks followed by ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
Receives: Drug: Doxorubicin; Drug: Ifosfamide

What is being measured

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

  1. Progression - Free Survival (PFS)

    The PFS was assessed as median number of days from the date of randomization until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.

    Measured: Every 6 weeks from randomization during the first 9 months and thereafter, every 9 weeks up to 20 months

Secondary outcomes (4)

  1. 6-month Progression - Free Survival

    Percentage of participants survived for 6 months from the start of study treatment without progression of disease. Progression of the disease was associated with increasing symptoms, including pain from new or progressing lesions. Delay in disease progression generally represents a clinical benefit to the participant.

    Measured: 6 months

  2. Percentage of Participants With Objective Response

    Tumor response was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Partial Response (PR)=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, Complete Response (CR) =Disappearance of all non-target lesions. Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants.

    Measured: Every 6 weeks during first 9 months of the study and thereafter every 9 weeks up to 20 months

  3. Overall Survival

    Overall survival defined as time from the date of randomization to the date of death. For participants who were alive at the time of analysis, overall survival was censored at the last contact date.

    Measured: Baseline up to End of Study (an average of 4 years)

  4. Duration of Response (DOR)

    The DOR is defined as the time from date of first documentation of response (CR or PR, whichever comes first) to the date of documented PD or death. PR=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, CR =Disappearance of all non-target lesions.

    Measured: Up to 20 months

Timeline

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

  1. First posted24 Nov 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionAug 2012
  4. Study completionAug 2014

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
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00796120
Sponsor's protocol ID
CR015769
Other IDs
ET-C-002-07
Status last verified
Dec 2015
First submitted
20 Nov 2008
Last updated
10 Dec 2015
Data monitoring committee
No

Publications

  • Blay JY, Leahy MG, Nguyen BB, Patel SR, Hohenberger P, Santoro A, Staddon AP, Penel N, Piperno-Neumann S, Hendifar A, Lardelli P, Nieto A, Alfaro V, Chawla SP. Randomised phase III trial of trabectedin versus doxorubicin-based chemotherapy as first-line therapy in translocation-related sarcomas. Eur J Cancer. 2014 Apr;50(6):1137-47. doi: 10.1016/j.ejca.2014.01.012. Epub 2014 Feb 7.

    PubMed 24512981

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trabectedin, Doxorubicin and Ifosfamide in people with Sarcoma, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 21 sites in 5 countries.

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 5 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: finished, as of the sponsor's last update on 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, France, United Kingdom, Germany, Spain. 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?

Yes. Results are posted in the registry (first posted 16 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (PFS) (time frame: Every 6 weeks from randomization during the first 9 months and thereafter, every 9 weeks up to 20 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 NCT00796120, which also lists 1 linked publication.

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 10 Dec 2015.

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