Clinical trial: Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia (NCT00003702)

Eligibility criteria:
Inclusion Criteria:

          -  Histologically proven low-risk gestational trophoblastic neoplasia (persistent
             hydatidiform mole or choriocarcinoma), defined as 1 of the following:

               -  Less than 10% decrease in the beta human chorionic gonadotropin (HCG) titer over
                  3 weekly titers

               -  Greater than 20% sustained rise in beta HCG titer over two consecutive weeks

               -  Persistently elevated beta HCG titer more than 4 months after initial curettage
                  (greater than 5 mIU/mL minimum)

               -  Histologically proven nonmetastatic choriocarcinoma

               -  Metastases to vagina, parametria, or lung (if no single pulmonary lesion is
                  greater than 2 cm)

          -  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

          -  Previously untreated disease

          -  Performance status - GOG 0-2

          -  WBC at least 3,000/mm^3

          -  Granulocyte count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

          -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)

          -  SGPT and SGOT no greater than 3 times ULN

          -  Alkaline phosphatase no greater than 3 times ULN

          -  No significant prior abnormal hepatic function

          -  Creatinine no greater than 2.0 mg/dL

          -  No significant prior abnormal renal function

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception during and for one year after study
             entry

          -  No other prior or concurrent malignancies within the past 5 years except
             nonmelanomatous skin cancer

          -  No prior chemotherapy for gestational trophoblastic neoplasia

          -  No concurrent curettage except as needed to control vaginal bleeding or to rule out
             placental site pseudotumor
Female
No healthy subjects accepted to join the trial.



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