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Second Curettage in Treating Patients With Persistent Non-metastatic Gestational Trophoblastic Tumors

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ClinicalTrials.gov Identifier: NCT00521118
Recruitment Status : Completed
First Posted : August 27, 2007
Last Update Posted : August 24, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Brief Summary:
This phase II trial studies how well a second curettage (removal of the abnormal cancer cells in the uterus using a method of surgically removing the lining of the uterus) works in treating patients with gestational trophoblastic tumors that did not go away after a first curettage (persistent) and has not yet spread to other places in the body (non-metastatic). A second curettage may be effective in treating persistent gestational trophoblastic tumors and may decrease the likelihood that patients will need chemotherapy in the near future.

Condition or disease Intervention/treatment Phase
Complete Hydatidiform Mole Non-Metastatic Gestational Trophoblastic Tumor Partial Hydatidiform Mole Other: Laboratory Biomarker Analysis Procedure: Therapeutic Conventional Surgery Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the response to second curettage in patients with persistent, non-metastatic gestational trophoblastic neoplasia (GTN).

SECONDARY OBJECTIVES:

I. 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.

II. 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).

III. 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.

IV. To estimate the frequency of a change in the uterine histology between the first and second curettage.

OUTLINE:

Patients undergo a second curettage rather than standard treatment (immediate chemotherapy) within 14 days of registration.

After completion of study treatment, patients are followed up at 14 days, weekly for 4 weeks, and then monthly for 5 months, and then every 3 months for 24 months.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : October 9, 2007
Actual Primary Completion Date : June 25, 2015
Actual Study Completion Date : June 25, 2015


Arm Intervention/treatment
Experimental: Treatment (second curettage)
Patients undergo a second curettage rather than standard treatment (immediate chemotherapy) within 14 days of registration.
Other: Laboratory Biomarker Analysis
Correlative studies

Procedure: Therapeutic Conventional Surgery
Undergo second curettage




Primary Outcome Measures :
  1. 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 [ Time Frame: Up to 6 months ]
  2. Frequency of surgical cure defined as normal beta-hCG level documented for 6 consecutive months AND no chemotherapy [ Time Frame: Up to 6 months ]
  3. Incidence of adverse effects of second curettage, assessed by Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 30 days after the surgical procedure ]
    The frequency and severity of the reported adverse effects of repeat evacuation will be tabulated. Specifically, uterine operative injury, hemorrhage, and infection (pelvis, fallopian tubes and ovaries) will be prospectively collected.

  4. Surgical failure, defined as the development of choriocarcinoma, placental site trophoblastic tumor, or epithelioid trophoblastic tumor histologically diagnosed at second curettage [ Time Frame: At time of surgery ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have had hydatidiform mole treated by evacuation and/or curettage and now meet the criteria of low risk GTN, as defined by the International Federation of Gynecology and Obstetrics (F.I.G.O.)/World Health Organization (W.H.O.) 2002 staging and risk scoring criteria:

    • A plateau in the beta-hCG assay for 4 consecutive weekly levels over a period of 3 weeks or longer; that is, days 1, 7, 14, 21; for this study, a plateau will be defined as less than a 10% decline using as a reference the initial value in the series of values taken over a period of 3 weeks; OR
    • A rise in the beta-hCG assay of 3 consecutive measurements, or longer, over at least a period of 2 weeks or more; days, 1, 7, 14; for this study, a rise will be defined as an increase of greater than 20% taking as a reference the initial value in the series of values taken over the 2-week period; OR
    • When the beta-hCG level remains elevated above normal for 6 months or longer
  • Patients must have a clinically significant elevated beta-hCG level of greater than 20 mIU/ml
  • Patients must have non-metastatic low risk GTN with a W.H.O. 2002 risk score of no greater than 6
  • Patients must have no metastatic disease as determined by the pelvic examination, pelvic ultrasound, and chest x-ray
  • Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
  • Patients must have a Gynecologic Oncology Group (GOG) performance status of 0 or 1
  • Patients must have histologically confirmed complete or partial mole
  • Patients must agree to use an accepted method of contraception (oral contraceptives, birth control patches, Depo-Provera, diaphragm, contraceptive foam and condom, or male/female sterilization)
  • Patients must meet pre-entry requirements

Exclusion Criteria:

  • Patients who do not have persistent low-risk GTN
  • Patients with any evidence of metastatic disease beyond the uterus
  • Patients with persistent or recurrent GTN (same gestation) that have already been treated with chemotherapy
  • Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, patients who have had any evidence of the other cancer present within the last 5 years or patients whose previous cancer treatment contraindicates this protocol therapy
  • Patients with histologically confirmed choriocarcinoma, placental site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT) on the first curettage
  • Patients who refuse to use an accepted method of contraception
  • Patients who have had more than one curettage for the management of the current disease or who have undergone hysterectomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00521118


  Hide Study Locations
Locations
United States, California
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, United States, 94040
Stanford Cancer Institute
Palo Alto, California, United States, 94304
UCSF Medical Center-Mount Zion
San Francisco, California, United States, 94115
Olive View-University of California Los Angeles Medical Center
Sylmar, California, United States, 91342
United States, Colorado
Colorado Gynecologic Oncology Group
Aurora, Colorado, United States, 80010
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
United States, Georgia
Memorial University Medical Center
Savannah, Georgia, United States, 31404
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Michigan
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
United States, Nevada
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89169
United States, New Jersey
Virtua Memorial
Mount Holly, New Jersey, United States, 08060
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Virtua Voorhees
Voorhees, New Jersey, United States, 08043
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87102
United States, New York
State University of New York Downstate Medical Center
Brooklyn, New York, United States, 11203
United States, North Carolina
Gynecologic Oncology Network
Greenville, North Carolina, United States, 27834
United States, Ohio
University of Cincinnati/Barrett Cancer Center
Cincinnati, Ohio, United States, 45219
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, United States, 74146
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
United States, Texas
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
United States, Virginia
Carilion Clinic Gynecological Oncology
Roanoke, Virginia, United States, 24016
Canada, Ontario
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Raymond Osborne NRG Oncology

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00521118     History of Changes
Other Study ID Numbers: GOG-0242
NCI-2009-00606 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GOG-0242
CDR0000561984
GOG-0242 ( Other Identifier: NRG Oncology )
GOG-0242 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Posted: August 27, 2007    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017

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