Phase IIb: To evaluate the most effective dosing schedule of trabectedin.Phase III: To evaluate whether trabectedin given as 1st line chemothearpy for advanced/metastatic soft tissue sarcoma prolongs progression free surivival, as compared to…
ID
Source
Brief title
Condition
- Soft tissue neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Progression free survival and treatment safety of the two experimental arms.
Secondary outcome
not applicable.
Background summary
Doxorubicin is the most active treatment for advanced and/or metastatic soft
tissue sarcoma. The response rate is 23% with a median progression free
survival of 6 months. Trabectedin is a newer drug that has been found effective
in second and third line treatment. Two schedules of trabectedine have been
used: infusion during 3 hours of during 24 hours.
Study objective
Phase IIb: To evaluate the most effective dosing schedule of trabectedin.
Phase III: To evaluate whether trabectedin given as 1st line chemothearpy for
advanced/metastatic soft tissue sarcoma prolongs progression free surivival, as
compared to doxorubicin.
Study design
This is a randomized multicenter phase IIb/III trial. Eligible patients will be
randomized at the EORTC headquarters to receive doxorubicin (standard
treatment) or trabectedin (investigational treatment).
Intervention
In step 1 (phase IIb) patients will be randomized between doxorubicin,
trabectedin (3 hrs IV) and trabectedin (24 hrs IV). In step 2 (phase III)
additional patients will be randomized between the trabectedin schedule
selected at the end of step 1, and doxorubicin.
Study burden and risks
The visits to the physician/hospital, the frequency of CT scans and MUGA scans
is similar as for the standard of care with doxorubicin. Filling out the EORTC
QLQ-C30 is extra.
Patients treated with trabectedin will need a central venous line. Patients
that receive 24-hour infusion of trabectedin will stay at the hospital one
night every three weeks.
Avenue E. Mounier 83, bte 11
1200 Brussel
BE
Avenue E. Mounier 83, bte 11
1200 Brussel
BE
Listed location countries
Age
Inclusion criteria
-histological proven advanced and/or metastatic malignant soft tissue sarcoma intermediate/high grade
-presence of measurable disease according to RECIST 1.1
-no prior anthracycline therapy in (neo)adjuvant setting
-no prior chemotherapy in advanced/metastatic setting
-no other anti-cancer treatment within 28 days prior tot treatment start
-at least 18 years old
-WHO performance status 0 or 1
-adequate bone marrow, kidney and liver function
-normal cardiac function
Exclusion criteria
-active or uncontrolled infections or serious illnesses or medical conditions
-history, within the past 5 years, of malignancies other than soft tissues sarcoma (a few exceptions)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-014889-26-NL |
| CCMO | NL35618.042.11 |