search
Back to results

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

Primary Purpose

Solitary Fibrous Tumors

Status
Recruiting
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Trabectedin
Adriamycin
Dacarbazine
Sponsored by
Italian Sarcoma Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solitary Fibrous Tumors

Eligibility Criteria

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

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

Sites / Locations

  • Nuovo Ospedale di PratoRecruiting
  • Fondazione IRCCS Istituto Nazionale dei TumoriRecruiting
  • Policlinico Universitario Campus BiomedicoRecruiting
  • IRCCS Istituto ortopedico RizzoliRecruiting
  • Fondazione Del Piemonte Per L'Oncologia Ircc Di Candiolo -Recruiting
  • Ospedale GiacconeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Trabectedin

Adriamycin and Dacarbazine

Arm Description

trabectedin: 1.5 mg/m² - 1.3 mg/m² given in 24-hour continuous infusion every 21 days for 6 cycles

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

Outcomes

Primary Outcome Measures

Overall Tumor Response Rate
evaluate the activity of trabectedin and of adriamycin in combination with dacarbazine, according to Response Evaluation Criteria in Solid Tumor (RECIST), version 1.1

Secondary Outcome Measures

Choi Response Rate
Percentage of patient who experienced Complete or Partial Responses after treatment according to Choi Criteria.
Overall Survival (OS)
Time from the date of enrollment to date of death
Progression Free Survival (PFS)
Survival free of progressive disease evaluated from enrollment up to progression according to RECIST, or death
Clinical Benefit Rate (CBR)
Percentage of patients who have achieved complete response, partial response or stable disease ≥ 6 months
Response rate by RECIST after the cross over
Percentage of patient who experienced Complete or Partial Responses according RECIST 1.1 after cross over
Progression Free Survival (PFS) after cross over up to progression according to RECIST, or death
Survival free of progressive disease evaluated from
Safety according to Common Terminology Criteria for Adverse Events (CTCAE)
Safety profile of the treatment evaluated according to Common Terminology Criteria for Adverse Events version 4.03

Full Information

First Posted
December 19, 2016
Last Updated
September 12, 2023
Sponsor
Italian Sarcoma Group
search

1. Study Identification

Unique Protocol Identification Number
NCT03023124
Brief Title
Study With Trabectedin Versus Adriamycin Plus Dacarbazine, in Patients With Advanced Solitary Fibrous Tumor
Acronym
STRADA
Official Title
Solitary Fibrous Tumor: Phase II Study on Trabectedin Versus Adriamycin Plus Dacarbazine in Advanced Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 4, 2018 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solitary Fibrous Tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trabectedin
Arm Type
Experimental
Arm Description
trabectedin: 1.5 mg/m² - 1.3 mg/m² given in 24-hour continuous infusion every 21 days for 6 cycles
Arm Title
Adriamycin and Dacarbazine
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Trabectedin
Intervention Description
Treatment with trabectedin repeated every 21 days for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Adriamycin
Intervention Description
Treatment with Adriamycin at day 1 every 21 days for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Dacarbazine
Intervention Description
Treatment with Dacarbazine at days 1 and 2 every 21 days for 6 cycles
Primary Outcome Measure Information:
Title
Overall Tumor Response Rate
Description
evaluate the activity of trabectedin and of adriamycin in combination with dacarbazine, according to Response Evaluation Criteria in Solid Tumor (RECIST), version 1.1
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.
Secondary Outcome Measure Information:
Title
Choi Response Rate
Description
Percentage of patient who experienced Complete or Partial Responses after treatment according to Choi Criteria.
Time Frame
week 6, week 12, week 18, then every 12 weeks up to 54 weeks
Title
Overall Survival (OS)
Description
Time from the date of enrollment to date of death
Time Frame
From enrollment up to 5 years
Title
Progression Free Survival (PFS)
Description
Survival free of progressive disease evaluated from enrollment up to progression according to RECIST, or death
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
Title
Clinical Benefit Rate (CBR)
Description
Percentage of patients who have achieved complete response, partial response or stable disease ≥ 6 months
Time Frame
week 6, week 12, week 18, then every 12 weeks up to 54 weeks
Title
Response rate by RECIST after the cross over
Description
Percentage of patient who experienced Complete or Partial Responses according RECIST 1.1 after cross over
Time Frame
week 18, week 24, week 30, week 36 and then every 12 weeks up to 54 weeks
Title
Progression Free Survival (PFS) after cross over up to progression according to RECIST, or death
Description
Survival free of progressive disease evaluated from
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
Title
Safety according to Common Terminology Criteria for Adverse Events (CTCAE)
Description
Safety profile of the treatment evaluated according to Common Terminology Criteria for Adverse Events version 4.03
Time Frame
From enrollment every 3 weeks up to 54 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Age ≥18 years Histological centrally and molecularly confirmed diagnosis of solitary fibrous tumor (inclusive of the last available tumor sample) 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 Measurable or evaluable disease with RECIST Evidence of progression by RECIST during the 6 months before study entry 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. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 Adequate bone marrow function Adequate organ function Cardiac ejection fraction ≥50% as measured by echocardiogram 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. No history of arterial and/or venous thromboembolic event within the previous 12 months. Exclusion Criteria: Any prior treatment with cytotoxic chemotherapy >1 line of anticancer targeted agents Previous treatment with any other investigational or not investigational agents within 14 days of first day of study drug dosing 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 Previous radiotherapy to 25 % of the bone marrow Major surgery within 4 weeks prior to study entry 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 Pregnancy or breast feeding 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 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 Known history of human immunodeficiency virus infection Active or chronic hepatitis B or C requiring treatment with antiviral therapy 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 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 Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs Expected non-compliance to medical regimens
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emanuela Marchesi
Phone
+390516366
Ext
470
Email
emanuela.marchesi@ior.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Stacchiotti, MD
Organizational Affiliation
Italian Sarcoma Group
Official's Role
Principal Investigator
Facility Information:
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
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
State/Province
MI
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Stacchiotti, MD
Email
silvia.stacchiotti@istitutotumori.mi.it
First Name & Middle Initial & Last Name & Degree
Silvia Stacchiotti, 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 Istituto ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emanuela Palmerini, MD
Phone
+390516366
Ext
199
Email
emanuela.palmerini@ior.it
First Name & Middle Initial & Last Name & Degree
Michela Pierini, PhD
Phone
+390516366
Ext
668
Email
michela.pierini@ior.it
First Name & Middle Initial & Last Name & Degree
Emanuela Palmerini, MD
Facility Name
Fondazione Del Piemonte Per L'Oncologia Ircc Di Candiolo -
City
Candiolo
ZIP/Postal Code
10060
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Giaccone
City
Palermo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Badalamenti, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26022454
Citation
Dagrada GP, Spagnuolo RD, Mauro V, Tamborini E, Cesana L, Gronchi A, Stacchiotti S, Pierotti MA, Negri T, Pilotti S. Solitary fibrous tumors: loss of chimeric protein expression and genomic instability mark dedifferentiation. Mod Pathol. 2015 Aug;28(8):1074-83. doi: 10.1038/modpathol.2015.70. Epub 2015 May 29.
Results Reference
background
PubMed Identifier
6682161
Citation
Beadle GF, Hillcoat BL. Treatment of advanced malignant hemangiopericytoma with combination adriamycin and DTIC: a report of four cases. J Surg Oncol. 1983 Mar;22(3):167-70. doi: 10.1002/jso.2930220306.
Results Reference
background
PubMed Identifier
23566418
Citation
Stacchiotti S, Libertini M, Negri T, Palassini E, Gronchi A, Fatigoni S, Poletti P, Vincenzi B, Dei Tos AP, Mariani L, Pilotti S, Casali PG. Response to chemotherapy of solitary fibrous tumour: a retrospective study. Eur J Cancer. 2013 Jul;49(10):2376-83. doi: 10.1016/j.ejca.2013.03.017. Epub 2013 Apr 6.
Results Reference
background
PubMed Identifier
23888069
Citation
Stacchiotti S, Tortoreto M, Bozzi F, Tamborini E, Morosi C, Messina A, Libertini M, Palassini E, Cominetti D, Negri T, Gronchi A, Pilotti S, Zaffaroni N, Casali PG. Dacarbazine in solitary fibrous tumor: a case series analysis and preclinical evidence vis-a-vis temozolomide and antiangiogenics. Clin Cancer Res. 2013 Sep 15;19(18):5192-201. doi: 10.1158/1078-0432.CCR-13-0776. Epub 2013 Jul 25.
Results Reference
background
PubMed Identifier
23663788
Citation
Park MS, Ravi V, Conley A, Patel SR, Trent JC, Lev DC, Lazar AJ, Wang WL, Benjamin RS, Araujo DM. The role of chemotherapy in advanced solitary fibrous tumors: a retrospective analysis. Clin Sarcoma Res. 2013 May 11;3(1):7. doi: 10.1186/2045-3329-3-7.
Results Reference
background
PubMed Identifier
22066036
Citation
Chaigneau L, Kalbacher E, Thiery-Vuillemin A, Fagnoni-Legat C, Isambert N, Aherfi L, Pauchot J, Delroeux D, Servagi-Vernat S, Mansi L, Pivot X. Efficacy of trabectedin in metastatic solitary fibrous tumor. Rare Tumors. 2011 Jul 11;3(3):e29. doi: 10.4081/rt.2011.e29. Epub 2011 Jul 18.
Results Reference
background
PubMed Identifier
26472661
Citation
Khalifa J, Ouali M, Chaltiel L, Le Guellec S, Le Cesne A, Blay JY, Cousin P, Chaigneau L, Bompas E, Piperno-Neumann S, Bui-Nguyen B, Rios M, Delord JP, Penel N, Chevreau C. Efficacy of trabectedin in malignant solitary fibrous tumors: a retrospective analysis from the French Sarcoma Group. BMC Cancer. 2015 Oct 15;15:700. doi: 10.1186/s12885-015-1697-8.
Results Reference
background
PubMed Identifier
19352594
Citation
Domont J, Massard C, Lassau N, Armand JP, Le Cesne A, Soria JC. Hemangiopericytoma and antiangiogenic therapy: clinical benefit of antiangiogenic therapy (sorafenib and sunitinib) in relapsed malignant haemangioperyctoma /solitary fibrous tumour. Invest New Drugs. 2010 Apr;28(2):199-202. doi: 10.1007/s10637-009-9249-1. Epub 2009 Apr 8. No abstract available.
Results Reference
background
PubMed Identifier
21480200
Citation
Park MS, Patel SR, Ludwig JA, Trent JC, Conrad CA, Lazar AJ, Wang WL, Boonsirikamchai P, Choi H, Wang X, Benjamin RS, Araujo DM. Activity of temozolomide and bevacizumab in the treatment of locally advanced, recurrent, and metastatic hemangiopericytoma and malignant solitary fibrous tumor. Cancer. 2011 Nov 1;117(21):4939-47. doi: 10.1002/cncr.26098. Epub 2011 Apr 8.
Results Reference
background
PubMed Identifier
24005614
Citation
Valentin T, Fournier C, Penel N, Bompas E, Chaigneau L, Isambert N, Chevreau C. Sorafenib in patients with progressive malignant solitary fibrous tumors: a subgroup analysis from a phase II study of the French Sarcoma Group (GSF/GETO). Invest New Drugs. 2013 Dec;31(6):1626-7. doi: 10.1007/s10637-013-0023-z. Epub 2013 Sep 5.
Results Reference
background
PubMed Identifier
25269954
Citation
Stacchiotti S, Tortoreto M, Baldi GG, Grignani G, Toss A, Badalamenti G, Cominetti D, Morosi C, Dei Tos AP, Festinese F, Fumagalli E, Provenzano S, Gronchi A, Pennacchioli E, Negri T, Dagrada GP, Spagnuolo RD, Pilotti S, Casali PG, Zaffaroni N. Preclinical and clinical evidence of activity of pazopanib in solitary fibrous tumour. Eur J Cancer. 2014 Nov;50(17):3021-8. doi: 10.1016/j.ejca.2014.09.004. Epub 2014 Sep 27.
Results Reference
background
PubMed Identifier
27185843
Citation
Martin-Broto J, Pousa AL, de Las Penas R, Garcia Del Muro X, Gutierrez A, Martinez-Trufero J, Cruz J, Alvarez R, Cubedo R, Redondo A, Maurel J, Carrasco JA, Lopez-Martin JA, Sala A, Meana JA, Ramos R, Martinez-Serra J, Lopez-Guerrero JA, Sevilla I, Balana C, Vaz A, De Juan A, Alemany R, Poveda A. Randomized Phase II Study of Trabectedin and Doxorubicin Compared With Doxorubicin Alone as First-Line Treatment in Patients With Advanced Soft Tissue Sarcomas: A Spanish Group for Research on Sarcoma Study. J Clin Oncol. 2016 Jul 1;34(19):2294-302. doi: 10.1200/JCO.2015.65.3329. Epub 2016 May 16.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs