To improve overall survival of patients with a early-stage high grade uterine leiomyosarcoma.
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine whether overall survival of patients with uterus-limited
high-grade leiomyosarcoma is superior among patients assigned to
treatment with adjuvant gemcitabine plus docetaxel followed by
doxorubicin compared to patients assigned to observation.
Secondary outcome
To determine whether treatment with adjuvant gemcitabine plus docetaxel
followed by doxorubicin improves recurrence-free survival of patients
with uterus-limited high-grade leiomyosarcoma compared to observation.
To explore the impact of potential predictors of recurrence or death such
as patient age, and institution reported tumor size, cervix involvement (yes
or no), and mitotic rate.
Background summary
Patients with early-stage, high-grade uterine leiomyosarcoma (LMS) have a 50-
70% chance of relapse/recurrence of disease. Recurrences may be distant or local
or both. In one GOG study of prognostic factors for recurrence of LMS, only
14% of patients with stage I or II disease had isolated pelvic recurrences as
the
site of first recurrence. Adjuvant pelvic radiation can decrease local
recurrence
rates, but has not been shown to increase overall survival. In the EORTC
randomized trial of adjuvant whole pelvic radiation v. observation for FIGO
stage
I and II uterine sarcomas, the recurrence rates were approximately 50% in both
arms of the study. The percentage of leiomyosarcoma patients remaining
progression-free at 2 years in that study was approximately 58%, and the
percentage of all patients (both uterine LMS and uterine carcinosarcoma) that
remained progression-free at 3 years was 52%.
A recent prospective phase II study of adjuvant gemcitabine plus docetaxel
followed by doxorubicin for women with uterus-limited high-grade LMS was
conducted by the Sarcoma Alliance for Research through Collaboration (SARC)
and the results were presented at the American Society of Clinical Oncology
(Hensley, ASCO 2010). In that study (SARC005), 47 women with uterus-limited
high-grade LMS were enrolled over 3 years' time. All patients were treated with
adjuvant gemcitabine + docetaxel for four cycles. Provided that repeat CT
imaging showed no evidence of disease, patients then received four cycles of
doxorubicin. All patients were followed with CT imaging every 3 months for 2
years, then every 6 months for 3 years.
Study objective
To improve overall survival of patients with a early-stage high grade uterine
leiomyosarcoma.
Study design
Enroll Patients with
1) High-grade uterine LMS
2) FIGO Stage I (uterus +/- cervix)
Hysterectomy +/- BSO
Randomize of the patient
Regimen 1: gemcitabine on day 1 and 8
Docetaxel on day 8
GCSF on day 9-15 or pegfilgrastim on day 9 and 10
Every 21 days for 4 cycles
CT/MRI imaging to confirm disease-free
Doxorubicin 60 mg/m2 IV every 21 days for 4 cycles
regime 2
observation
Intervention
-in ona study arm patients will recieve a maximum of 8 courses of chmeotherapy
( 4 courses gemcitabine/docetaxel) and 4 courses doxorubicine.
Study burden and risks
Side effects of the chemotherapy
Avenue Emanual Mounier 83/11
Brussel 1200
BE
Avenue Emanual Mounier 83/11
Brussel 1200
BE
Listed location countries
Age
Inclusion criteria
Patients with a high risk of uterine leiomyosarcoma FIGO stage I.
Institutional pathology review of leiomyosarcoma
Al patients must be no longer than 12 weeks (3 months) from surgical resection of cancer at the time of enrollment on study.
Age > 18 years
Written informed consent
Exclusion criteria
Patient who had prior therapy with docetaxel or gemcitabine or doxorubicine
Patient with a history of malignancy being present within the last 5 years
Patient with a history of severe hypersensitivity reaction to anthracenedione/anthracyclines or drugs containing polysorbate 80 excipients are not allowed to participate in the study.
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 | EUCTR2012-002852-17-NL |
| ClinicalTrials.gov | NCT01533207 |
| CCMO | NL48441.042.14 |