Clinical trial: Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia (NCT01535053)

Eligibility criteria:
Inclusion Criteria:

          -  Patients who meet International Federation of Gynecology and Obstetrics (FIGO) stage
             I, II, or III criteria for low-risk gestational trophoblastic neoplasia (GTN): post
             molar GTN or choriocarcinoma (as defined below); patients may have had a second
             curettage but must still meet GTN criteria below:

               -  Post molar GTN

                    -  For the purposes of this study, patients must have undergone evacuation of a
                       complete or partial hydatidiform mole and then meet the criteria for GTN
                       defined as:

                         -  A < 10% decrease in the hCG level using as a reference the first value
                            in the series of 4 values taken over a period of 3 weeks (> 50 mIU/ml
                            minimum) OR

                         -  A > 20% sustained rise in the hCG taking as a reference the first value
                            in the series of 3 values taken over a period of 2 weeks (> 50 mIU/ml
                            minimum) OR

                         -  A persistently elevated hCG level a period of 6 months or more
                            following the initial curettage (> 50 mIU/ml minimum)

               -  Choriocarcinoma

                    -  Histologically proven non-metastatic choriocarcinoma OR

                    -  Histologically proven metastatic choriocarcinoma if the metastatic site(s)
                       is restricted to one (or more) of the following: vagina, parametrium, or
                       lung

          -  World Health Organization (WHO) risk score 0-6

          -  Patients must be willing to practice effective contraception for the duration of the
             study

          -  White blood cell count (WBC) >= 3,000 cells/mcL

          -  Granulocytes >= 1,500/mcL

          -  Platelets >= 100,000/mcL

          -  Creatinine =< 2.0 mg/dcL

          -  Bilirubin =< 1.5 x institutional normal

          -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x
             institutional normal

          -  Alkaline phosphatase =< 3 x institutional normal

          -  Patients who have met the pre-entry requirements

          -  Before enrolling a patient, the institution must verify the availability of an
             adequate supply of methotrexate for a full course of therapy

          -  Patients must have signed an approved informed consent and authorization permitting
             release of personal health information

        Exclusion Criteria:

          -  Patients who do not have GTN

          -  Patients with non-gestational choriocarcinoma

          -  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

          -  Patients who have received prior pelvic radiation

          -  Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic
             tumor (ETT)

          -  Patients with Gynecologic Oncology Group (GOG) performance status of 3 or 4

          -  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

          -  Patients whose circumstances at the time of study entry do not permit completion of
             the study or required follow-up

          -  Patients who wish to breast-feed during treatment
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? Contradiction