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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
N/A
N/A
Open (Enrolling)
Female
Gestational Trophoblastic Tumor

Thank you

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


OBJECTIVES:

Primary

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

Secondary

- 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.

- 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


DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

- 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

PRIOR CONCURRENT THERAPY:

- 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:

Interventional

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:

No

Principal Investigator

Raymond Osborne, MD, FRCSC, MBA

Investigator Role:

Study Chair

Investigator Affiliation:

Edmond Odette Cancer Centre at Sunnybrook

Authority:

Unspecified

Study ID:

CDR0000561984

NCT ID:

NCT00521118

Start Date:

October 2007

Completion Date:

Related Keywords:

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

Name

Location

Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Lake/University Ireland Cancer CenterMentor, Ohio  44060
Carilion Gynecologic Oncology AssociatesRoanoke, Virginia  24014
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
Cancer Care Associates - Saint Francis CampusTulsa, Oklahoma  74136-1929
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Parkland Memorial HospitalDallas, Texas  75235
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
Women's Cancer Center - La CanadaLas Vegas, Nevada  89169
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045