Maintenance therapy with trabectedin versus observation after first line treatment with doxorubicin of patients with advanced or metastatic soft tissue sarcoma

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 8

Inclusion Criteria

* Histologically proven locally advanced or metastatic high grade STS (excluding histologies insensitive to chemotherapy such as ASPS and PECOMA subtypes).;* Non-progressive disease (CR, PR or SD according to RECIST 1.1) after 6 cycles of first-line chemotherapy with doxorubicin for advanced and/or metastatic malignant STS.;* Interval from last dose of doxorubicin to randomization is maximum 6 weeks.;* Prior neoadjuvant or adjuvant non-anthracycline-chemotherapy is allowed, provided that the disease did not progress during neoadjuvant and/or adjuvant therapy or within 12 weeks after completion of the perioperative treatment.;* Representative formalin fixed, paraffin embedded tumor blocks or 10 unstained tissue slides, either from the primary tumor or a metastatic lesion, must be available for histological central review. Histological central review is not required before treatment start but it is mandatory to send unstained tumor slides (blocks optional) at time of study entry. Local histopathological diagnosis will be accepted for entry into this trial.;* Age 18 years or older;* WHO performance status (PS) * 1;* Adequate bone marrow, liver and renal function and coagulation parameters;* Normal cardiac function (LVEF assessed by MUGA or ECHO within normal range of the institution), normal 12 lead ECG (without clinically significant abnormalities).;* Recovery from toxicity (no more than Grade 1, except for alopecia);* Evidence of post-menopausal status or for female pre-menopausal patients negative urinary or serum pregnancy test within 72 hours prior to first dose of study treatment. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: ;* Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy). ;* Women *50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).;* Women of childbearing potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 3 months after the last study treatment. Men in fertile age must use effective contraception during treatment and 5 months after treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.;Such methods include:;* Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal);* Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable);* Intrauterine device (IUD);* Intrauterine hormone-releasing system (IUS);* Bilateral tubal occlusion;* Vasectomised partner;* Sexual abstinence;* Note: Trabectedin can have genotoxic effe

Exclusion Criteria

* prior exposure to trabectedin;* active or uncontrolled infections or serious illnesses or medical conditions, including a * history of chronic alcohol abuse, hepatitis, HIV and/or cirrhosis.;* active brain metastases;* history, within the past five years, of malignancies other than soft tissue sarcoma (except: basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix, resected incidental prostate cancer staged pT2 with Gleason Score * 6 and postoperative PSA < 0.5 ng/ml). Patients with any history of malignancies who are disease-free for more than 5 years are eligible.;* any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary end-point is progression-free survival defined from randomization<br /><br>until progression according to RECIST 1.1.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary end-points include:<br /><br>* Safety and tolerability (Common Terminology Criteria for Adverse EventsCTCAE<br /><br>4.0)<br /><br>* Overall survival<br /><br>* Time to second progression (PFS2)<br /><br>* Health related quality of life (QLQ-C30)</p><br>