Complete Hydatidiform MolePhase 2NCT00521118
Second Curettage in Treating Patients With Persistent Non-metastatic Gestational Trophoblastic Tumors
A Phase 2 study testing Laboratory Biomarker Analysis and Therapeutic Conventional Surgery in people with Complete Hydatidiform Mole and Non-Metastatic Gestational Trophoblastic Tumor, run by Gynecologic Oncology Group at 29 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Complete Hydatidiform Mole, Non-Metastatic Gestational Trophoblastic Tumor, Partial Hydatidiform Mole
- What is being tested?
- Laboratory Biomarker Analysis and Therapeutic Conventional Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 29 sitesin 2 countries
- Study dates
- 9 Oct 2007to 25 Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
29 sites in 2 countries.
29 sites in 2 countries
United States28 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19001
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102
Colorado Gynecologic Oncology Group
Aurora, Colorado, 80010
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, 80045
State University of New York Downstate Medical Center
Brooklyn, New York, 11203
Northwestern University
Chicago, Illinois, 60611
University of Cincinnati/Barrett Cancer Center
Cincinnati, Ohio, 45219
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Parkland Memorial Hospital
Dallas, Texas, 75235
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Gynecologic Oncology Network
Greenville, North Carolina, 27834
Hartford Hospital
Hartford, Connecticut, 06102
Borgess Medical Center
Kalamazoo, Michigan, 49001
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89169
Virtua Memorial
Mount Holly, New Jersey, 08060
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, 94040
The Hospital of Central Connecticut
New Britain, Connecticut, 06050
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Stanford Cancer Institute
Palo Alto, California, 94304
Carilion Clinic Gynecological Oncology
Roanoke, Virginia, 24016
UCSF Medical Center-Mount Zion
San Francisco, California, 94115
Memorial University Medical Center
Savannah, Georgia, 31404
Olive View-University of California Los Angeles Medical Center
Sylmar, California, 91342
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146
Virtua Voorhees
Voorhees Township, New Jersey, 08043
Canada1 site
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the response to second curettage in patients with persistent, non-metastatic gestational trophoblastic neoplasia (GTN).
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Complete Hydatidiform Mole, Non-Metastatic Gestational Trophoblastic Tumor, Partial Hydatidiform Mole
- Being tested
- Laboratory Biomarker Analysis, Therapeutic Conventional Surgery
- Medical subject headings
- Hydatidiform Mole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
Therapeutic Conventional SurgeryProcedure or surgery
Undergo second curettage
| Study group | Role | What they receive |
|---|---|---|
| Treatment (second curettage) | Experimental | Patients undergo a second curettage rather than standard treatment (immediate chemotherapy) within 14 days of registration. Receives: Other: Laboratory Biomarker Analysis; Procedure: Therapeutic Conventional Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 6 months
Frequency of surgical cure defined as normal beta-hCG level documented for 6 consecutive months AND no chemotherapy
Measured: Up to 6 months
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.
Measured: Up to 30 days after the surgical procedure
Surgical failure, defined as the development of choriocarcinoma, placental site trophoblastic tumor, or epithelioid trophoblastic tumor histologically diagnosed at second curettage
Measured: At time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2007 (estimated)
- Study start9 Oct 2007
- Primary completion25 Jun 2015
- Study completion25 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complete Hydatidiform MoleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Raymond Osborne, Principal investigator, NRG Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521118
- Sponsor's protocol ID
- GOG-0242
- Other IDs
- NCI-2009-00606, GOG-0242, CDR0000561984, GOG-0242, GOG-0242, U10CA180868, U10CA027469
- Status last verified
- Aug 2017
- First submitted
- 24 Aug 2007
- Last updated
- 24 Aug 2017
- Results posted
- No
Publications
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.
PubMed 27500329
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00521118
- Acronym / sponsor ID
- GOG-0242
- Conditions
- Complete Hydatidiform Mole, Non-Metastatic Gestational Trophoblastic Tumor, Partial Hydatidiform Mole
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Oct 2007 (actual)
- Primary completion
- 25 Jun 2015 (actual)
- Study completion
- 25 Jun 2015 (actual)
- First posted
- 27 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the response to second curettage in patients with persistent, non-metastatic gestational trophoblastic neoplasia (GTN).
SECONDARY OBJECTIVES:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (second curettage) | Experimental | Other: Laboratory Biomarker Analysis, Procedure: Therapeutic Conventional SurgeryPatients undergo a second curettage rather than standard treatment (immediate chemotherapy) within 14 days of registration. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (second curettage) |
| Therapeutic Conventional SurgeryUndergo second curettage | Procedure or surgery | Treatment (second curettage) |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
- Derived from this study: PubMed 27500329Osborne 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.
Related trials for Complete Hydatidiform Mole
Active, not recruitingObservational study
Study of the Genetic and Epigenetic Causes of Recurrent Hydatidiform Moles
Hydatidiform Moles
RecruitingObservational study
The French National Reference Centre of GTD
Neoplasm, Trophoblastic, Gestational Trophoblastic Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond Osborne principal investigator
NRG Oncology
29 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laboratory Biomarker Analysis and Therapeutic Conventional Surgery in people with Complete Hydatidiform Mole and Non-Metastatic Gestational Trophoblastic Tumor, run by Gynecologic Oncology Group at 29 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00521118, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2017.