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

Primary Purpose

Complete Hydatidiform Mole, Non-Metastatic Gestational Trophoblastic Tumor, Partial Hydatidiform Mole

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Laboratory Biomarker Analysis
Therapeutic Conventional Surgery
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complete Hydatidiform Mole

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Palo Alto Medical Foundation-Gynecologic Oncology
  • Stanford Cancer Institute
  • UCSF Medical Center-Mount Zion
  • Olive View-University of California Los Angeles Medical Center
  • Colorado Gynecologic Oncology Group
  • University of Colorado Cancer Center - Anschutz Cancer Pavilion
  • Hartford Hospital
  • The Hospital of Central Connecticut
  • Memorial University Medical Center
  • Northwestern University
  • Borgess Medical Center
  • Bronson Methodist Hospital
  • West Michigan Cancer Center
  • Women's Cancer Center of Nevada
  • Virtua Memorial
  • Rutgers Cancer Institute of New Jersey
  • Virtua Voorhees
  • University of New Mexico Cancer Center
  • State University of New York Downstate Medical Center
  • Gynecologic Oncology Network
  • University of Cincinnati/Barrett Cancer Center
  • Ohio State University Comprehensive Cancer Center
  • University of Oklahoma Health Sciences Center
  • Oklahoma Cancer Specialists and Research Institute-Tulsa
  • Abington Memorial Hospital
  • Parkland Memorial Hospital
  • UT Southwestern/Simmons Cancer Center-Dallas
  • Carilion Clinic Gynecological Oncology
  • Odette Cancer Centre- Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (second curettage)

Arm Description

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

Outcomes

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
Frequency of surgical cure defined as normal beta-hCG level documented for 6 consecutive months AND no chemotherapy
Incidence of adverse effects of second curettage, assessed by Common Terminology Criteria for Adverse Events version 4.0
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

Secondary Outcome Measures

Full Information

First Posted
August 24, 2007
Last Updated
August 23, 2017
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00521118
Brief Title
Second Curettage in Treating Patients With Persistent Non-metastatic Gestational Trophoblastic Tumors
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 9, 2007 (Actual)
Primary Completion Date
June 25, 2015 (Actual)
Study Completion Date
June 25, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complete Hydatidiform Mole, Non-Metastatic Gestational Trophoblastic Tumor, Partial Hydatidiform Mole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (second curettage)
Arm Type
Experimental
Arm Description
Patients undergo a second curettage rather than standard treatment (immediate chemotherapy) within 14 days of registration.
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Procedure
Intervention Name(s)
Therapeutic Conventional Surgery
Intervention Description
Undergo second curettage
Primary Outcome Measure Information:
Title
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
Title
Frequency of surgical cure defined as normal beta-hCG level documented for 6 consecutive months AND no chemotherapy
Time Frame
Up to 6 months
Title
Incidence of adverse effects of second curettage, assessed by Common Terminology Criteria for Adverse Events version 4.0
Description
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.
Time Frame
Up to 30 days after the surgical procedure
Title
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

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Osborne
Organizational Affiliation
NRG Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Palo Alto Medical Foundation-Gynecologic Oncology
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Stanford Cancer Institute
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
UCSF Medical Center-Mount Zion
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Olive View-University of California Los Angeles Medical Center
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
Colorado Gynecologic Oncology Group
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
University of Colorado Cancer Center - Anschutz Cancer Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
The Hospital of Central Connecticut
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
Facility Name
Memorial University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Borgess Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49001
Country
United States
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Women's Cancer Center of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Virtua Memorial
City
Mount Holly
State/Province
New Jersey
ZIP/Postal Code
08060
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Virtua Voorhees
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
State University of New York Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Gynecologic Oncology Network
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
University of Cincinnati/Barrett Cancer Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oklahoma Cancer Specialists and Research Institute-Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Parkland Memorial Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
UT Southwestern/Simmons Cancer Center-Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Carilion Clinic Gynecological Oncology
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
Facility Name
Odette Cancer Centre- Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
27500329
Citation
Osborne RJ, Filiaci VL, Schink JC, Mannel RS, Behbakht K, Hoffman JS, Spirtos NM, Chan JK, Tidy JA, Miller DS. Second Curettage for Low-Risk Nonmetastatic Gestational Trophoblastic Neoplasia. Obstet Gynecol. 2016 Sep;128(3):535-542. doi: 10.1097/AOG.0000000000001554.
Results Reference
derived

Learn more about this trial

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

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