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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
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
  Purpose

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.


Condition Intervention Phase
Gestational Trophoblastic Tumor
Other: laboratory biomarker analysis
Procedure: conventional surgery
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study to Determine the Response to Second Curettage as Initial Management for Persistent Low Risk, Non-Metastatic Gestational Trophoblastic Neoplasia

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 66
Study Start Date: October 2007
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00521118

Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States, 80045
United States, Georgia
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403-3089
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
United States, Nevada
Women's Cancer Center - La Canada
Las Vegas, Nevada, United States, 89169
United States, New Jersey
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States, 08053
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees, New Jersey, United States, 08043
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-5636
United States, Ohio
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210-1240
Lake/University Ireland Cancer Center
Mentor, Ohio, United States, 44060
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
Cancer Care Associates - Saint Francis Campus
Tulsa, Oklahoma, United States, 74136-1929
United States, Pennsylvania
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
United States, Texas
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
United States, Virginia
Carilion Gynecologic Oncology Associates
Roanoke, Virginia, United States, 24016
Canada, Ontario
Edmond Odette Cancer Centre at Sunnybrook
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Raymond Osborne, MD, FRCSC, MBA Toronto Sunnybrook Regional Cancer Centre
OverallOfficial: Julian C. Schink, MD Robert H. Lurie Cancer Center
OverallOfficial: Mostafa Atri, MD, Dip, Epid Toronto Sunnybrook Regional Cancer Centre
OverallOfficial: David S. Miller, MD Simmons Cancer Center
  More Information

Responsible Party: Philip J. DiSaia, Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00521118     History of Changes
Other Study ID Numbers: CDR0000561984  GOG-0242 
Study First Received: August 24, 2007
Last Updated: March 29, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
nonmetastatic gestational trophoblastic tumor
hydatidiform mole

Additional relevant MeSH terms:
Trophoblastic Neoplasms
Gestational Trophoblastic Disease
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Pregnancy Complications, Neoplastic
Pregnancy Complications

ClinicalTrials.gov processed this record on December 06, 2016