Second Curettage in Treating Patients With Persistent Non-Metastatic Gestational Trophoblastic Tumor

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00521118
First received: August 24, 2007
Last updated: March 29, 2011
Last verified: March 2011

August 24, 2007
March 29, 2011
October 2007
June 2010   (final data collection date for primary outcome measure)
  • Frequency of surgical cure, defined a normal beta-human chorionic gonadotropin (hCG) level documented for 6 consecutive months AND no chemotherapy [ Designated as safety issue: No ]
  • Development of choriocarcinoma, placental site trophoblastic tumor (PSTT), or epithelioid trophoblastic tumor (ETT) histologically diagnosed at second curettage [ Designated as safety issue: No ]
  • Development of "second persistent" disease, defined as failure to achieve or maintain a normal assay, or a plateau, or a rise in the assay level after second curettage [ Designated as safety issue: No ]
  • Frequency and severity of adverse effects of second curettage, specifically uterine operative injury, hemorrhage, and infection (pelvis, fallopian tubes, and ovaries), as assessed by CTCAE version 3.0 [ Designated as safety issue: Yes ]
  • Frequency of surgical cure, defined a normal beta-human chorionic gonadotropin (hCG) level documented for 6 consecutive months AND no chemotherapy
  • Development of choriocarcinoma, placental site trophoblastic tumor (PSTT), or epithelioid trophoblastic tumor (ETT) histologically diagnosed at second curettage
  • Development of "second persistent" disease, defined as failure to achieve or maintain a normal assay, or a plateau, or a rise in the assay level after second curettage
  • Frequency and severity of adverse effects of second curettage, specifically uterine operative injury, hemorrhage, and infection (pelvis, fallopian tubes, and ovaries), as assessed by CTCAE version 3.0
Complete list of historical versions of study NCT00521118 on ClinicalTrials.gov Archive Site
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Second Curettage in Treating Patients With Persistent Non-Metastatic Gestational Trophoblastic Tumor
A Phase II Study to Determine the Response to Second Curettage as Initial Management for Persistent Low Risk, Non-Metastatic Gestational Trophoblastic Neoplasia

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.

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Gestational Trophoblastic Tumor
  • Other: laboratory biomarker analysis
  • Procedure: conventional surgery
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
66
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June 2010   (final data collection date for primary outcome measure)

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
Female
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No
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United States,   Canada
 
NCT00521118
CDR0000561984, GOG-0242
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Philip J. DiSaia, Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Raymond Osborne, MD, FRCSC, MBA Edmond Odette Cancer Centre at Sunnybrook
Investigator: Julian C. Schink, MD Robert H. Lurie Cancer Center
Investigator: Mostafa Atri, MD, Dip, Epid Edmond Odette Cancer Centre at Sunnybrook
Investigator: David S. Miller, MD Simmons Cancer Center
National Cancer Institute (NCI)
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP