A PHASE III RANDOMIZED TRIAL OF PULSE ACTINOMYCIN-D VERSUS MULTI-DAY METHOTREXATE FOR THE TREATMENT OF LOW-RISK GESTATIONAL TROPHOBLASTIC NEOPLASIA
- Conditions
- OW-RISK GESTATIONAL TROPHOBLASTIC NEOPLASIA
- Registration Number
- JPRN-UMIN000011154
- Lead Sponsor
- Gynecologic Oncology Group
- Brief Summary
Schink JC, et al. Gynecol Oncol 2020; 158(2): 354-360
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 6
Not provided
1)Patients who do not have GTN as defined in Key inclusion criteria 1). 2)Patients with non-gestational choriocarcinoma. 3)Patients who have previously been treated with cytotoxic chemotherapy. However, patients who received prior low-dose methotrexate for treatment of an ectopic pregnancy will be eligible for this study. 4)Patients who have received prior pelvic radiation. 5)Patients with placental site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT). 6)Patients with GOG Performance status of 3 or 4. 7)Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy. 8)Patients whose circumstances at the time of study entry do not permit completion of the study or required follow-up. 9)Patients who wish to breast-feed during treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete response vs treatment failure
- Secondary Outcome Measures
Name Time Method Severity of adverse events, W.H.O. risk score, choriocarcinoma histology, uterine artery pulsatility index