Clincosm LogoSign in Get a demo

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

Sponsor
Gynecologic Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00521118
Collaborator
National Cancer Institute (NCI) (NIH)
64
Enrollment
29
Locations
1
Arm
92.5
Actual Duration (Months)
2.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: Laboratory Biomarker Analysis
  • Procedure: Therapeutic Conventional Surgery
 Phase 2

Detailed Description

PRIMARY OBJECTIVES:
  1. To determine the response to second curettage in patients with persistent, non-metastatic gestational trophoblastic neoplasia (GTN).
SECONDARY OBJECTIVES:

  1. 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.

  2. 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).

  3. 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.

  4. 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 Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
N/A
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 :
Oct 9, 2007
Actual Primary Completion Date :
Jun 25, 2015
Actual Study Completion Date :
Jun 25, 2015

Arms and Interventions

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

Outcome Measures

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 [Up to 6 months]

  2. Frequency of surgical cure defined as normal beta-hCG level documented for 6 consecutive months AND no chemotherapy [Up to 6 months]

  3. Incidence of adverse effects of second curettage, assessed by Common Terminology Criteria for Adverse Events version 4.0 [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 [At time of surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Palo Alto Medical Foundation-Gynecologic Oncology Mountain View California United States 94040
2 Stanford Cancer Institute Palo Alto California United States 94304
3 UCSF Medical Center-Mount Zion San Francisco California United States 94115
4 Olive View-University of California Los Angeles Medical Center Sylmar California United States 91342
5 Colorado Gynecologic Oncology Group Aurora Colorado United States 80010
6 University of Colorado Cancer Center - Anschutz Cancer Pavilion Aurora Colorado United States 80045
7 Hartford Hospital Hartford Connecticut United States 06102
8 The Hospital of Central Connecticut New Britain Connecticut United States 06050
9 Memorial University Medical Center Savannah Georgia United States 31404
10 Northwestern University Chicago Illinois United States 60611
11 Borgess Medical Center Kalamazoo Michigan United States 49001
12 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
13 West Michigan Cancer Center Kalamazoo Michigan United States 49007
14 Women's Cancer Center of Nevada Las Vegas Nevada United States 89169
15 Virtua Memorial Mount Holly New Jersey United States 08060
16 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08903
17 Virtua Voorhees Voorhees New Jersey United States 08043
18 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
19 State University of New York Downstate Medical Center Brooklyn New York United States 11203
20 Gynecologic Oncology Network Greenville North Carolina United States 27834
21 University of Cincinnati/Barrett Cancer Center Cincinnati Ohio United States 45219
22 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
23 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
24 Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa Oklahoma United States 74146
25 Abington Memorial Hospital Abington Pennsylvania United States 19001
26 Parkland Memorial Hospital Dallas Texas United States 75235
27 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
28 Carilion Clinic Gynecological Oncology Roanoke Virginia United States 24016
29 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00521118
Other Study ID Numbers:
  • GOG-0242
  • NCI-2009-00606
  • GOG-0242
  • CDR0000561984
  • GOG-0242
  • GOG-0242
  • U10CA180868
  • U10CA027469
First Posted:
Aug 27, 2007
Last Update Posted:
Aug 24, 2017
Last Verified:
Aug 1, 2017
Additional relevant MeSH terms:
Trophoblastic Neoplasms
Gestational Trophoblastic Disease
Hydatidiform Mole

Study Results

No Results Posted as of Aug 24, 2017