View Clinical Trial (Medical Research Study)
A Phase II Study to Determine the Response to Second Curettage as Initial Management for Persistent Low Risk, Non-Metastatic Gestational Trophoblastic Neoplasia
| City: |
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Aurora |
| State: |
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Colorado |
| Zip Code: |
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80045 |
| Conditions: |
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Gestational Trophoblastic Tumor |
| Purpose: |
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RATIONALE: A second curettage may be effective in treating persistent gestational
trophoblastic tumor.
PURPOSE: This phase II trial is studying how well a second curettage works in treating
patients with persistent non-metastatic gestational trophoblastic tumor.
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| Study Summary: |
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OBJECTIVES:
Primary
- To determine the response to second curettage in patients with persistent,
non-metastatic gestational trophoblastic neoplasia (GTN).
Secondary
- To evaluate if response to a second curettage is independent of the tumor burden as
measured by the quantitative beta-human chorionic gonadotropin (hCG) assay at study
entry.
- To evaluate if response to a second curettage is independent of the depth of myometrial
invasion as measured sonographically following the initial curettage but prior to study
entry (when persistent disease is first diagnosed).
- To estimate the frequency of complications related to a second curettage, specifically
infection of the fallopian tubes or ovaries, hemorrhage associated with curettage, or
operative injury to the uterus.
- To estimate the frequency of a change in the uterine histology between the first and
second curettage.
OUTLINE: This is a multicenter study.
Patients undergo a second curettage rather than standard treatment (immediate chemotherapy).
Patients whose disease has transformed into choriocarcinoma, placental site trophoblastic
tumor, or epithelioid trophoblastic tumor (histologically diagnosed at the second curettage)
are removed from the study. All other patients undergo weekly beta-human chorionic
gonadotropin (hCG) testing beginning 14 days after the second curettage and continuing until
the beta-hCG level is normal. Patients then undergo further beta-HCG testing weekly for 4
weeks and then monthly for 5 months. If the level does not regress to normal, or rises, or
if metastatic disease is identified, the patient is removed from the study.
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| Criteria: |
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DISEASE CHARACTERISTICS:
- Histologically confirmed gestational trophoblastic neoplasia (GTN) (complete or
partial hydatidiform mole)
- No histologically confirmed choriocarcinoma, placental site trophoblastic tumor
(PSTT), or epithelioid trophoblastic tumor (ETT) on the first curettage
- Persistent, low-risk disease (based on FIGO/WHO 2002 staging and risk scoring
criteria), as defined by 1 of the following criteria:
- Less than 10% decline in beta-human chorionic gonadotropin (hCG) levels, based
on four consecutive measurements over a 3-week period (plateau)
- Greater than 20% rise in beta-hCG levels, based on three consecutive
measurements over a 2-week period
- Beta-hCG level remains elevated above normal for ≥ 6 months
- WHO risk score ≤ 6
- Must have a clinically significant elevated beta-hCG level
- Beta-hCG > 20 miu/mL
- Non-metastatic disease
- No evidence of metastatic disease beyond the uterus by pelvic examination,
pelvic ultrasound, and chest x-ray
- No previously treated, persistent or recurrent GTN (same gestation) that have been
treated with chemotherapy
PATIENT CHARACTERISTICS:
- GOG performance status 0-1
- Fertile patients must use effective contraception during and for 6 months after
completion of study therapy
- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
- No prior cancer treatment that would preclude study treatment
- No more than 1 prior curettage for current disease
- No prior hysterectomy
- No chemotherapy during the study curettage follow-up period until surgical response
has been completely determined
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| NCT ID: |
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NCT00521118 |
| Primary Contact: |
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Study Chair
Raymond Osborne, MD, FRCSC, MBA
Edmond Odette Cancer Centre at Sunnybrook
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| Backup Contact: |
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N/A |
| Location Contact: |
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Aurora, Colorado 80045
United States
Clinical Trials Office - University of Colorado Cancer Center
Phone: 720-848-0650
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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