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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00521118
First Posted: August 27, 2007
Last Update Posted: August 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
  Purpose
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 Intervention Phase
Complete Hydatidiform Mole Non-Metastatic Gestational Trophoblastic Tumor Partial Hydatidiform Mole Other: Laboratory Biomarker Analysis Procedure: Therapeutic Conventional Surgery Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • 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 ]
  • Frequency of surgical cure defined as normal beta-hCG level documented for 6 consecutive months AND no chemotherapy [ Time Frame: Up to 6 months ]
  • 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.

  • 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 ]

Enrollment: 64
Actual Study Start Date: October 9, 2007
Study Completion Date: June 25, 2015
Primary Completion Date: June 25, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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
  Contacts and Locations
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


  Show 29 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Raymond Osborne NRG Oncology
  More Information

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) )
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 Submitted: August 24, 2007
First Posted: August 27, 2007
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