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Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma (ISG-ARTICLE)

Primary Purpose

Leiomyosarcoma of Ovary, Soft Tissue Sarcoma

Status
Recruiting
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Trabectedin
Gemcitabine
No Intervention: Observational Cohort
Sponsored by
Italian Sarcoma Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leiomyosarcoma of Ovary focused on measuring advanced leiomyosarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with histologically documented diagnosis of leiomyosarcoma
  2. Patients with diagnosis of unresectable or metastatic leiomyosarcoma
  3. Patients who received at least on previous systemic treatment with anthracycline-based chemotherapy.
  4. Patients suitable to receive gemcitabine or trabectedin therapy.
  5. Measurable or evaluable disease with RECIST 1.1 criteria.
  6. Evidence of progression according RECIST 1.1 during the 6 months before study entry.
  7. Age ≥18 years
  8. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
  9. All previous anticancer treatments must have completed ≥ 3 weeks prior to first dose of study drug.
  10. The patient has resolution of adverse events, with the exception of alopecia, and of all clinically significant toxic effects of prior loco-regional therapy, surgery, radiotherapy or systemic anticancer therapy to ≤ Grade 1, by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
  11. Adequate bone marrow, liver and renal function
  12. Left Ventricular Ejection Fraction ≥ 50% and/or above lower institutional limit of normality.
  13. Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation each cycle of chemotherapy.
  14. No history of arterial and/or venous thromboembolic event within the previous 12 months.
  15. The patient or legal representative must be able to read and understand the informed consent form and must have been willing to give written informed consent prior to any study specific procedure. The subject may also provide an optional consent for the biological/translational sub-study associated.

Exclusion Criteria:

  1. Prior treatment with Trabectedin and/or Gemcitabine
  2. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs
  3. History of other malignancies (except basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission from 5 years or more and judged of negligible potential of relapse.
  4. Persistent toxicities with the exception of alopecia, caused by previous anticancer therapies
  5. Metastatic brain or meningeal tumors
  6. Active viral hepatitis
  7. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus
  8. Patients with any severe and/or uncontrolled medical conditions
  9. Medical history of hemorrhage or a bleeding event ≥ Grade 3 (NCI-CTCAE v 5.0) within 4 weeks prior to the initiation of study treatment
  10. Active clinically serious infections
  11. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus
  12. Previous treatment with radiation therapy within 14 days of first day of study drug dosing,
  13. Major surgery within 4 weeks prior to study entry
  14. Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors
  15. Concomitant use of known strong or moderate CYP3A inducers
  16. Patients undergoing renal dialysis or with Creatinin Clearance <30 ml/min or Creatinine >1,5 mg/dL
  17. Pregnant or breast feeding patients
  18. Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol

Sites / Locations

  • Azienda Ospedaliera S. Orsola-MalpighiRecruiting
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRSTRecruiting
  • Nuovo Ospedale di PratoRecruiting
  • Istituto Clinico HumanitasRecruiting
  • Centro di Riferimento Oncologico di Aviano
  • Policlinico Universitario Campus BiomedicoRecruiting
  • IRCCS Fondazione Piemonte per l'OncologiaRecruiting
  • Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal TumorsRecruiting
  • H.San Martino di GenovaRecruiting
  • Fondazione IRCCS INT Milano
  • Istituto Europeo di OncologiaRecruiting
  • IRCCS Istituto nazionale Tumori "Fondazione G.Pascale"Recruiting
  • Irccs Istituto Oncologico Veneto (Iov)Recruiting
  • Ospedale GiacconeRecruiting
  • Istituto Regina Elena - IFORecruiting
  • ASL Città di Torino (Dipartimento di Oncologia)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Arm A

Arm B

Observational Cohort

Arm Description

Trabectedin at the dose of 1.5 mg/m2-1.3 mg/m2 with a top-dose of 2.6 total mg per cycle (according the clinical practice in pretreated patients and in all our ISG studies) will be administered via a central venous catheter as a 24-hour infusion on day 1 of 21-days treatment cycles

Gemcitabine 800-1000 mg/m2 will be administered via a central venous catheter on days 1,8 every 21 days

Treatmen according clinical practice (not defined in advance). The patient who will refuse randomization between Arm A and B can choose to participate to the observational cohort to the study, where they will be treated according clinical practice

Outcomes

Primary Outcome Measures

Compare the Growth Modulation Index (GMI) in patients treated with Trabectedin or Gemcitabine in second line
Ratio of Time To Progression with the nth line (TTPn) of therapy to the TTPn-1 with the n-1th line.

Secondary Outcome Measures

Overall Response Rate
Overall response rate according Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Overall Survival (OS)
Survival from the first dose treatment to death for any cause
Progression free Survival (PFS)
Survival without disease progression
Duration of response
Duration of tumor control according Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Adverse events related to the treatment
Safety in term of adverse event is evaluate from the first treatment dose throughout the study according to CTCAE 5.0
Compare the Growth Modulation Index (GMI) in patients treated with Trabectedin or Gemcitabine after second line
Ratio of Time To Progression with the Mth line (TTPn) of therapy to the TTPn-1 with the n-1th line.

Full Information

First Posted
May 4, 2020
Last Updated
September 12, 2023
Sponsor
Italian Sarcoma Group
Collaborators
PharmaMar
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1. Study Identification

Unique Protocol Identification Number
NCT04383119
Brief Title
Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma
Acronym
ISG-ARTICLE
Official Title
A Randomized Phase II Trial Comparing the Activity of trabectedIn vs Gemcitabine in Patients With Metastatic or Locally Advanced Leiomyosarcoma Pretreated With Conventional Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 29, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Italian Sarcoma Group
Collaborators
PharmaMar

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Study is aimed at evaluating the activity of Trabectedin (arm A) in advanced leiomyosarcomas, having Gemcitabine (arm B) as the comparator. In addition to the randomized cohort, the study has also an observational prospective cohort which include patients who will refuse the randomization or for whom the investigator will not judge the randomization as an appropriate option. In order to allow the participation of sites only to the prospective-observational (non randomized) cohort, it was introduced the possibility to participate to the study and receive the ethical approval only to the Observational Prospective Cohort In parallel an optional translational study will be performed, in both cohorts, to identify factors predictive of the activity of Trabectedin or Gemcitabine in this specific histotype.
Detailed Description
The management of patients with leiomyosarcomas determines many difficulties. Despite patients with metastatic disease at diagnosis or who recur after initial treatment have a dismal prognosis and, except for a subset of selected patients with completely resectable disease, the median survival is less than two years. At the advanced-disease stage, the main aim of treatment is to improve patient's quality of life, possibly survival, with the best compromise between toxicity and symptoms. Trabectedin (T) is a marine-derived cytotoxic approved by European MEdicine Agency (EMEA) and FDA. It is indicated for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines-based chemotherapy or who are unsuitable to receive these agents. Among Soft Tissue Sarcoma (STS), activity has been mainly detected in synovial sarcoma, liposarcoma and leiomyosarcoma. Although the response rate did not exceed 10%, T was demonstrated to provide disease control, with progression arrest rates exceeding 50% and progression-free survival rates exceeding 20% at 6 months. So far no phase II or III studies have been addressed to test the activity of T in leiomyosarcoma specifically (without differentiation between site of primary localization) in comparison with Gemcitabine. This study is aimed at evaluating the activity of Trabectedin (arm A) in advanced leiomyosarcomas, having Gemcitabine (arm B) as the comparator. In parallel an optional translational study will be performed to identify factors predictive of the activity of Trabectedin or Gemcitabine in this specific histotype. In addition to the randomized cohort, the study has also an observational prospective cohort which include patients who will refuse the randomization or for whom the investigator will not judge the randomization as an appropriate option. In order to allow the participation of sites only to the prospective-observational (non randomized) cohort, it was introduced the possibility to participate to the study and receive the ethical approval only to the Observational Prospective Cohort In parallel an optional translational study will be performed, in both cohorts, to identify factors predictive of the activity of Trabectedin or Gemcitabine in this specific histotype.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leiomyosarcoma of Ovary, Soft Tissue Sarcoma
Keywords
advanced leiomyosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
multicenter, randomized, open-label, two arms with crossover. Patients will be randomized to receive Trabectedin (arm A) or Gemcitabine (arm B). In case of progressive disease (PD) or unacceptable toxicity during the assigned treatment, the patient will switched to the other arm
Masking
None (Open Label)
Masking Description
Not applicable (open label study)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
Trabectedin at the dose of 1.5 mg/m2-1.3 mg/m2 with a top-dose of 2.6 total mg per cycle (according the clinical practice in pretreated patients and in all our ISG studies) will be administered via a central venous catheter as a 24-hour infusion on day 1 of 21-days treatment cycles
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
Gemcitabine 800-1000 mg/m2 will be administered via a central venous catheter on days 1,8 every 21 days
Arm Title
Observational Cohort
Arm Type
Active Comparator
Arm Description
Treatmen according clinical practice (not defined in advance). The patient who will refuse randomization between Arm A and B can choose to participate to the observational cohort to the study, where they will be treated according clinical practice
Intervention Type
Drug
Intervention Name(s)
Trabectedin
Other Intervention Name(s)
Trabectedin arm
Intervention Description
Trabectedin in monotherapy
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemcitabine arm
Intervention Description
Gemcitabine, control arm
Intervention Type
Drug
Intervention Name(s)
No Intervention: Observational Cohort
Intervention Description
Treatment according clinical practice
Primary Outcome Measure Information:
Title
Compare the Growth Modulation Index (GMI) in patients treated with Trabectedin or Gemcitabine in second line
Description
Ratio of Time To Progression with the nth line (TTPn) of therapy to the TTPn-1 with the n-1th line.
Time Frame
Week 6, week 12, week 18, week 27, week 36 and week 45
Secondary Outcome Measure Information:
Title
Overall Response Rate
Description
Overall response rate according Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time Frame
Week 6, week 12, week 18, week 27, week 36 and week 45
Title
Overall Survival (OS)
Description
Survival from the first dose treatment to death for any cause
Time Frame
3 years and 5 years
Title
Progression free Survival (PFS)
Description
Survival without disease progression
Time Frame
6 months
Title
Duration of response
Description
Duration of tumor control according Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time Frame
Week 6, week 12, week 18, week 27, week 36 and week 45
Title
Adverse events related to the treatment
Description
Safety in term of adverse event is evaluate from the first treatment dose throughout the study according to CTCAE 5.0
Time Frame
Week 3, week 6, week 9, week 12, week 18, week 27, week 36, week 45
Title
Compare the Growth Modulation Index (GMI) in patients treated with Trabectedin or Gemcitabine after second line
Description
Ratio of Time To Progression with the Mth line (TTPn) of therapy to the TTPn-1 with the n-1th line.
Time Frame
Week 6, week 12, week 18, week 27, week 36 and week 45
Other Pre-specified Outcome Measures:
Title
Exploratory objectives
Description
Identify gene mutations that may be associated to response/resistance to the treatment and to clinical outcomes parameters.
Time Frame
week 6, and at up to week 53

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with histologically documented diagnosis of leiomyosarcoma Patients with diagnosis of unresectable or metastatic leiomyosarcoma Patients who received at least on previous systemic treatment with anthracycline-based chemotherapy. Patients suitable to receive gemcitabine or trabectedin therapy. Measurable or evaluable disease with RECIST 1.1 criteria. Evidence of progression according RECIST 1.1 during the 6 months before study entry. Age ≥18 years Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 All previous anticancer treatments must have completed ≥ 3 weeks prior to first dose of study drug. The patient has resolution of adverse events, with the exception of alopecia, and of all clinically significant toxic effects of prior loco-regional therapy, surgery, radiotherapy or systemic anticancer therapy to ≤ Grade 1, by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 Adequate bone marrow, liver and renal function Left Ventricular Ejection Fraction ≥ 50% and/or above lower institutional limit of normality. Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation each cycle of chemotherapy. No history of arterial and/or venous thromboembolic event within the previous 12 months. The patient or legal representative must be able to read and understand the informed consent form and must have been willing to give written informed consent prior to any study specific procedure. The subject may also provide an optional consent for the biological/translational sub-study associated. Exclusion Criteria: Prior treatment with Trabectedin and/or Gemcitabine Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs History of other malignancies (except basal cell carcinoma or cervical carcinoma in situ, adequately treated), unless in remission from 5 years or more and judged of negligible potential of relapse. Persistent toxicities with the exception of alopecia, caused by previous anticancer therapies Metastatic brain or meningeal tumors Active viral hepatitis Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus Patients with any severe and/or uncontrolled medical conditions Medical history of hemorrhage or a bleeding event ≥ Grade 3 (NCI-CTCAE v 5.0) within 4 weeks prior to the initiation of study treatment Active clinically serious infections Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus Previous treatment with radiation therapy within 14 days of first day of study drug dosing, Major surgery within 4 weeks prior to study entry Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors Concomitant use of known strong or moderate CYP3A inducers Patients undergoing renal dialysis or with Creatinin Clearance <30 ml/min or Creatinine >1,5 mg/dL Pregnant or breast feeding patients Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno Vincenzi, Prof/MD
Phone
003906-22541
Ext
1123
Email
b.vincenzi@unicampus.it
First Name & Middle Initial & Last Name or Official Title & Degree
Emanuela Marchesi, PhD
Phone
003905101459
Ext
78
Email
emanuela.marchesi@italiansarconmagroup.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Vincenzi, Prof/MD
Organizational Affiliation
Campus Biomedico of Rome
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliera S. Orsola-Malpighi
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margherita Nannini, MD
Phone
+39 051 2144043
Email
margherita.nannini@aosp.bo.it
First Name & Middle Initial & Last Name & Degree
Margherita Nannini, MD
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST
City
Meldola
State/Province
FC
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valentina Fausti, MD
Email
valentina.fausti@irst.emr.it
First Name & Middle Initial & Last Name & Degree
Valentina Fausti, MD
Facility Name
Nuovo Ospedale di Prato
City
Prato
State/Province
Firenze
ZIP/Postal Code
59100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giacomo G. Baldi, MD
Phone
0039057443
Ext
4766
Email
giacomogiulio.baldi@uslcentro.toscana.it
First Name & Middle Initial & Last Name & Degree
Giacomo G. Baldi, MD
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
MI
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexia Bertuzzi, MD
Phone
+390282244540
Email
alexia.bertuzzi@cancercenter.humanitas.it
First Name & Middle Initial & Last Name & Degree
Alexia Bertuzzi, MD
Facility Name
Centro di Riferimento Oncologico di Aviano
City
Aviano
State/Province
PD
ZIP/Postal Code
33081
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Buonadonna, MD
Phone
+39 0434 659190
Email
abuonadonna@cro.it
First Name & Middle Initial & Last Name & Degree
Angela Buonadonna, MD
Facility Name
Policlinico Universitario Campus Biomedico
City
Roma
State/Province
RM
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno Vincenzi, MD
Phone
+3902225411123
Email
b.vincenzi@unicampus.it
First Name & Middle Initial & Last Name & Degree
Bruno Vincenzi, MD
Facility Name
IRCCS Fondazione Piemonte per l'Oncologia
City
Candiolo
State/Province
Torino
ZIP/Postal Code
10060
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Aliberti, MD
Phone
+39.011.9933
Ext
278
Email
sandra.aliberti@ircc.it
First Name & Middle Initial & Last Name & Degree
Sandra Aliberti, MD
Facility Name
Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toni Ibrahim, MD
Phone
+390516366
Ext
199
Email
toni.ibrahim@ior.it
First Name & Middle Initial & Last Name & Degree
Toni Ibrahim, MD
Facility Name
H.San Martino di Genova
City
Genova
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Comandini Danila, MD
Email
danila.comandini@hsanmartino.it
Facility Name
Fondazione IRCCS INT Milano
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberta Sanfilippo, MD
Phone
+390223903
Ext
468
Email
roberta.sanfilippo@istitutotumori.mi.it
First Name & Middle Initial & Last Name & Degree
Roberta Sanfilippo, MD
Facility Name
Istituto Europeo di Oncologia
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabetta Setola, MD
Email
elisabetta.setola@ieo.it
Facility Name
IRCCS Istituto nazionale Tumori "Fondazione G.Pascale"
City
Napoli
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salvatore Tafuto, Prof
Email
s.tafuto@istitutotumori.na.it
Facility Name
Irccs Istituto Oncologico Veneto (Iov)
City
Padova
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonella Brunello, MD
Phone
0039049 8215
Ext
910
Email
antonella.brunello@ioveneto.it
First Name & Middle Initial & Last Name & Degree
Antonella Brunello, MD
Facility Name
Ospedale Giaccone
City
Palermo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Giuseppe, MD
Email
giuseppe.badalamenti@unipa.it
First Name & Middle Initial & Last Name & Degree
Giuseppe Giuseppe, MD
Facility Name
Istituto Regina Elena - IFO
City
Rome
ZIP/Postal Code
00100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Virginia Ferraresi, MD
Phone
+39065266919
Email
ferraresi@ifo.it
Facility Name
ASL Città di Torino (Dipartimento di Oncologia)
City
Torino
ZIP/Postal Code
10153
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonella Boglione, MD
Email
antonella.boglione@aslcittaditorino.it
First Name & Middle Initial & Last Name & Degree
Boglione, MD
First Name & Middle Initial & Last Name & Degree
Antonella Boglione, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not applicable no plan to share IPD
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Citation
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Demetri GD, Chawla SP, von Mehren M, Ritch P, Baker LH, Blay JY, Hande KR, Keohan ML, Samuels BL, Schuetze S, Lebedinsky C, Elsayed YA, Izquierdo MA, Gomez J, Park YC, Le Cesne A. Efficacy and safety of trabectedin in patients with advanced or metastatic liposarcoma or leiomyosarcoma after failure of prior anthracyclines and ifosfamide: results of a randomized phase II study of two different schedules. J Clin Oncol. 2009 Sep 1;27(25):4188-96. doi: 10.1200/JCO.2008.21.0088. Epub 2009 Aug 3.
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Patel SR, Gandhi V, Jenkins J, Papadopolous N, Burgess MA, Plager C, Plunkett W, Benjamin RS. Phase II clinical investigation of gemcitabine in advanced soft tissue sarcomas and window evaluation of dose rate on gemcitabine triphosphate accumulation. J Clin Oncol. 2001 Aug 1;19(15):3483-9. doi: 10.1200/JCO.2001.19.15.3483.
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Citation
Pautier P, Floquet A, Penel N, Piperno-Neumann S, Isambert N, Rey A, Bompas E, Cioffi A, Delcambre C, Cupissol D, Collin F, Blay JY, Jimenez M, Duffaud F. Randomized multicenter and stratified phase II study of gemcitabine alone versus gemcitabine and docetaxel in patients with metastatic or relapsed leiomyosarcomas: a Federation Nationale des Centres de Lutte Contre le Cancer (FNCLCC) French Sarcoma Group Study (TAXOGEM study). Oncologist. 2012;17(9):1213-20. doi: 10.1634/theoncologist.2011-0467. Epub 2012 Aug 20.
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Seddon B, Strauss SJ, Whelan J, Leahy M, Woll PJ, Cowie F, Rothermundt C, Wood Z, Benson C, Ali N, Marples M, Veal GJ, Jamieson D, Kuver K, Tirabosco R, Forsyth S, Nash S, Dehbi HM, Beare S. Gemcitabine and docetaxel versus doxorubicin as first-line treatment in previously untreated advanced unresectable or metastatic soft-tissue sarcomas (GeDDiS): a randomised controlled phase 3 trial. Lancet Oncol. 2017 Oct;18(10):1397-1410. doi: 10.1016/S1470-2045(17)30622-8. Epub 2017 Sep 4.
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Trial in Patients With Metastatic or Locally Advanced Leiomyosarcoma

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