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A Phase II Study to Determine the Response to Second Curettage as Initial Management for Persistent Low Risk, Non-Metastatic Gestational Trophoblastic Neoplasia

Phase 2
Open (Enrolling)
Gestational Trophoblastic Tumor

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Trial Information

A Phase II Study to Determine the Response to Second Curettage as Initial Management for Persistent Low Risk, Non-Metastatic Gestational Trophoblastic Neoplasia



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


- 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

- 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).

- 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.

- To estimate the frequency of a change in the uterine histology between the first and
second curettage.

OUTLINE: This is a multicenter study.

Patients undergo a second curettage rather than standard treatment (immediate chemotherapy).
Patients whose disease has transformed into choriocarcinoma, placental site trophoblastic
tumor, or epithelioid trophoblastic tumor (histologically diagnosed at the second curettage)
are removed from the study. All other patients undergo weekly beta-human chorionic
gonadotropin (hCG) testing beginning 14 days after the second curettage and continuing until
the beta-hCG level is normal. Patients then undergo further beta-HCG testing weekly for 4
weeks and then monthly for 5 months. If the level does not regress to normal, or rises, or
if metastatic disease is identified, the patient is removed from the study.

Inclusion Criteria


- Histologically confirmed gestational trophoblastic neoplasia (GTN) (complete or
partial hydatidiform mole)

- No histologically confirmed choriocarcinoma, placental site trophoblastic tumor
(PSTT), or epithelioid trophoblastic tumor (ETT) on the first curettage

- Persistent, low-risk disease (based on FIGO/WHO 2002 staging and risk scoring
criteria), as defined by 1 of the following criteria:

- Less than 10% decline in beta-human chorionic gonadotropin (hCG) levels, based
on four consecutive measurements over a 3-week period (plateau)

- Greater than 20% rise in beta-hCG levels, based on three consecutive
measurements over a 2-week period

- Beta-hCG level remains elevated above normal for ≥ 6 months

- WHO risk score ≤ 6

- Must have a clinically significant elevated beta-hCG level

- Beta-hCG > 20 miu/mL

- Non-metastatic disease

- No evidence of metastatic disease beyond the uterus by pelvic examination,
pelvic ultrasound, and chest x-ray

- No previously treated, persistent or recurrent GTN (same gestation) that have been
treated with chemotherapy


- GOG performance status 0-1

- Fertile patients must use effective contraception during and for 6 months after
completion of study therapy

- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer


- No prior cancer treatment that would preclude study treatment

- No more than 1 prior curettage for current disease

- No prior hysterectomy

- No chemotherapy during the study curettage follow-up period until surgical response
has been completely determined

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency of surgical cure, defined a normal beta-human chorionic gonadotropin (hCG) level documented for 6 consecutive months AND no chemotherapy

Safety Issue:


Principal Investigator

Raymond Osborne, MD, FRCSC, MBA

Investigator Role:

Study Chair

Investigator Affiliation:

Edmond Odette Cancer Centre at Sunnybrook



Study ID:




Start Date:

October 2007

Completion Date:

Related Keywords:

  • Gestational Trophoblastic Tumor
  • nonmetastatic gestational trophoblastic tumor
  • hydatidiform mole
  • Trophoblastic Neoplasms
  • Gestational Trophoblastic Neoplasms



Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065
Charles M. Barrett Cancer Center at University Hospital Cincinnati, Ohio  45267-0526
Lake/University Ireland Cancer Center Mentor, Ohio  44060
Carilion Gynecologic Oncology Associates Roanoke, Virginia  24014
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390
UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick, New Jersey  08903
University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Marlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West Jersey Voorhees, New Jersey  08043
Cancer Care Associates - Saint Francis Campus Tulsa, Oklahoma  74136-1929
Rosenfeld Cancer Center at Abington Memorial Hospital Abington, Pennsylvania  19001
Parkland Memorial Hospital Dallas, Texas  75235
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus, Ohio  43210-1240
Women's Cancer Center - La Canada Las Vegas, Nevada  89169
University of Colorado Cancer Center at UC Health Sciences Center Aurora, Colorado  80045