CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 240 enrolled
Drug / intervention
Dactinomycin +1 morebiological
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Histologically proven low-risk gestational trophoblastic neoplasia (persistent hydatidiform mole or choriocarcinoma) with defined HCG kinetics or metastatic disease
  • ✓WHO score 0-6 (not including blood group or CT lung)
  • ✓No histologically confirmed placental site pseudotumor
  • ✓Must have undergone at least 1 uterine curettage
Key exclusion· 5
  • ✕No prior chemotherapy for gestational trophoblastic neoplasia
  • ✕No other prior or concurrent malignancies within the past 5 years except nonmelanomatous skin cancer
  • ✕Significant prior abnormal hepatic function
  • ✕Significant prior abnormal renal function

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00003702
NCT00003702Phase 3Completed
CompareCT.gov

A Randomized Phase III Trial of Weekly Parenteral Methotrexate Versus "Pulsed" Dactinomycin as Primary Management for Low Risk Gestational Trophoblastic Neoplasia

Gynecologic Oncology Group·interventional·Posted Jan 27, 2003·Updated May 15, 2018

In Brief

A Phase 3 clinical trial evaluating Dactinomycin and Methotrexate for Good Prognosis Metastatic Gestational Trophoblastic Tumor and 3 related conditions. Completed, enrolled 240 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGood Prognosis Metastatic Gestational Trophoblastic Tumor, Hydatidiform Mole, Non-Metastatic Gestational Trophoblastic Tumor, Uterine Corpus Choriocarcinoma
CountriesUnited States
CollaboratorsEastern Cooperative Oncology Group, National Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartJun 1, 1999
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 11.1 yearsPosted 23.4 years ago

Interventions

Dactinomycinbiological

Given IV

Methotrexatedrug

Given intramuscularly