Biweekly Actinomycin-D Treatment or Multi-day Methotrexate Protocol in Low-risk Gestational Trophoblastic Neoplasia

xiang yang

Status: Active, not recruiting

Conditions: Stage I Gestational Trophoblastic Tumor; Stage III Gestational Trophoblastic Tumor; Invasive Mole; Choriocarcinoma; Gestational Trophoblastic Tumor; Stage II Gestational Trophoblastic Tumor; Gestational Trophoblastic Neoplasia

Treatments: Drug: Methotrexate; Drug: Leucovorin; Drug: Dactinomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT04562558

PUMCH-LRGTN-SINGLE DRUG-0222

Details and patient eligibility

About

The investigators conducted a randomized trial to study how well multi-day methotrexate protocol works compared to biweekly single-dose actinomycin D protocol in treating patients with low-risk gestational trophoblastic neoplasia. It is not yet known whether multi-day methotrexate protocol is as effective as biweekly single-dose actinomycin D protocol in treating patients with gestational trophoblastic neoplasia.

Enrollment: 228 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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
  • Histologically proven choriocarcinoma

• Stage I - III disease

• WHO risk score 0-4

• No prior chemotherapy for gestational trophoblastic neoplasia

• Signed informed consent

• Performance status - GOG 0-2

• Laboratory examination： WBC≥3.5×10(9)/L, Granulocyte count≥1.5×10(9)/L, Platelet count≥80×10(9)/L, serum bilirubin≤ 1.5 times the upper limit of normal, transaminase≤ 1.5 times the upper limit of normal, BUN, Creatinine≤ normal。 Fertile patients must use effective contraception during and for one year after study entry

Exclusion criteria

• Histologically confirmed placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)
• primary choriocarcinoma
• WHO risk score >4
• Previous MTX treatment for suspected ectopic pregnancy
• With severe or uncontrolled internal disease, unable to receive chemotherapy;
• Concurrently participating in other clinical trials
• Unable or unwilling to sign informed consents;
• Unable or unwilling to abide by protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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228 participants in 2 patient groups

Arm1-Methotrexate

Experimental group

Description:

Patients receive methotrexate intramuscularly（50mg） on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days. Patients continue on treatment until beta HCG titer is below the institutional normal. Patients then receive 2-3 additional consolidation treatment. If the level of hCG become stationary for at least 2 course of single-agent chemotherapy or rise again, the patient will be referred to multi-course chemotherapy. FAV regimen is preferred, or EMA-CO regimen can also be selected if FAV is unavailable.

Treatment:

Drug: Leucovorin

Drug: Methotrexate

Arm 2-Dactinomycin

Experimental group

Description:

Patients will receive IV pulse actinomycin-D (1.25mg/m2，2mg max dos) every 14 days. Patients continue on treatment until beta HCG titer is below the institutional normal. Patients then receive 2-3 additional consolidation treatment.If the level of hCG become stationary for at least 2 course of single-agent chemotherapy or rise again, the patient will be referred to multi-course chemotherapy. FAV regimen is preferred, or EMA-CO regimen can also be selected if FAV is unavailable.

Treatment:

Drug: Dactinomycin