CompletedPhase 2

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

Italy23 participantsStarted 2018-03-04

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

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

What they're measuring

Overall Tumor Response Rate

Timeframe: 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.

Trial details

NCT IDNCT03023124

SponsorItalian Sarcoma Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2024-12-06

View on ClinicalTrials.gov More Solitary Fibrous Tumors trials