Clinical trial · Interventional
Second Curettage in Treating Patients With Persistent Non-metastatic Gestational Trophoblastic Tumors
A Phase II Study to Determine the Response to Second Curettage as Initial Management for Persistent Low Risk, Non-metastatic Gestational Trophoblastic Neoplasia
NCT00521118CI-TRIAL-00029244completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Complete Hydatidiform Mole | Complete Hydatidiform Mole | ONTOLOGY_EXACT | 0.98 |
| Non-Metastatic Gestational Trophoblastic Tumor | — | UNRESOLVED | — |
| Partial Hydatidiform Mole | Partial Hydatidiform Mole | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Therapeutic Conventional Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (second curettage)
- description
- Patients undergo a second curettage rather than standard treatment (immediate chemotherapy) within 14 days of registration.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Procedure: Therapeutic Conventional Surgery
Primary outcomes (4)
- 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
- timeFrame
- Up to 6 months
- measure
- Frequency of surgical cure defined as normal beta-hCG level documented for 6 consecutive months AND no chemotherapy
- timeFrame
- Up to 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDOsborne 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. PMID 27500329