MedTrace Logo

Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia

NCT00003702 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2018-05-15

Study results available
· View outcomes & findings →

Summary

Randomized phase III trial to compare the effectiveness of methotrexate with that of dactinomycin in treating patients who have gestational trophoblastic neoplasia. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether methotrexate is more effective than dactinomycin in treating patients with gestational trophoblastic neoplasia.

Conditions

  • Good Prognosis Metastatic Gestational Trophoblastic Tumor
  • Hydatidiform Mole
  • Non-Metastatic Gestational Trophoblastic Tumor
  • Uterine Corpus Choriocarcinoma

Interventions

BIOLOGICAL

Dactinomycin

Given IV

DRUG

Methotrexate

Given intramuscularly

Sponsors & Collaborators

  • Eastern Cooperative Oncology Group

    collaborator NETWORK

  • National Cancer Institute (NCI)

    collaborator NIH

  • Gynecologic Oncology Group

    lead NETWORK

Principal Investigators

  • Raymond Osborne · Gynecologic Oncology Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-06-30
Primary Completion
2010-07-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00003702 on ClinicalTrials.gov