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NCT01535053 · ClinicalTrials.gov registry record · Phase 3
Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia
A Phase 3 study of Choriocarcinoma and Hydatidiform Mole, sponsored by GOG Foundation.
- Completed
- Registry status
- Phase 3
- Development phase
- 57
- Enrollment target
- 20
- Study locations
NCT01535053: Completed Phase 3 study of Choriocarcinoma and Hydatidiform Mole, sponsored by GOG Foundation.
NCT01535053 is a Phase 3 study of Choriocarcinoma and Hydatidiform Mole that has completed, run by GOG Foundation. The registered enrollment target is 57 participants, below the 357-participant average among 5 other Choriocarcinoma trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01535053, a Phase 3 study of Choriocarcinoma and Hydatidiform Mole, has completed, sponsored by GOG Foundation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 57 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III trial studies how well methotrexate works compared to dactinomycin in treating patients with low-risk gestational trophoblastic neoplasia. Drugs used in chemotherapy, such as methotrexate and dactinomycin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether methotrexate is more effective than dactinomycin in treating gestational trophoblastic disease.
Primary Outcome
Complete Response is defined as 3 consecutive bi-weekly values of hCG\<5 over a minimum of 4 weeks of normal hCG values with no values greater than 5 mIU/ml
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- DRUG Leucovorin Calcium
- DRUG Methotrexate
- BIOLOGICAL Dactinomycin
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Regional Hospital - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
California
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- UC San Diego Moores Cancer Center - La Jolla
- Loma Linda University Medical Center - Loma Linda
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
Georgia
- Northside Hospital - Atlanta
- Augusta University Medical Center - Augusta
- Northside Hospital-Forsyth - Cumming
Arizona
- Cancer Center at Saint Joseph's - Phoenix
- Saint Joseph's Hospital and Medical Center - Phoenix
Connecticut
- Hartford Hospital - Hartford
- The Hospital of Central Connecticut - New Britain
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2012-06-18 |
| Est. Completion | 2020-07-17 |
| Phase | Phase 3 |
What the finished NCT01535053 record still lists
NCT01535053 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 357-participant average among 5 other Choriocarcinoma trials with a reported enrollment target (84% lower).
The record links to 5 conditions, with Choriocarcinoma appearing as the primary indexed condition, and to 4 interventions - of which Quality-of-Life Assessment is the first listed.
NCT01535053 names 20 study sites across 5 states, led by Alaska, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT01535053 about?
NCT01535053 is a clinical study titled "Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia". This randomized phase III trial studies how well methotrexate works compared to dactinomycin in treating patients with low-risk gestational trophoblastic neoplasia. Drugs used in chemotherapy, such as methotrexate and dactinomycin, work in different ways to stop the growth of tumor cells, either by ...
What is the current status of trial NCT01535053?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 57 participants. The study started on 2012-06-18. Estimated completion is 2020-07-17.
What conditions does trial NCT01535053 study?
This clinical trial studies the following conditions: Choriocarcinoma, Hydatidiform Mole, FIGO Stage I Gestational Trophoblastic Tumor, FIGO Stage II Gestational Trophoblastic Tumor, FIGO Stage III Gestational Trophoblastic Tumor.
What interventions are being tested in trial NCT01535053?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Leucovorin Calcium (DRUG), Methotrexate (DRUG), Dactinomycin (BIOLOGICAL).
Who is sponsoring clinical trial NCT01535053?
This trial is sponsored by GOG Foundation, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01535053 being conducted?
This trial has 20 study locations across Alaska, Arizona, California, Connecticut, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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