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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-29

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Gestational Trophoblastic Tumor Gestational Trophoblastic Neoplasia Stage I Gestational Trophoblastic Tumor Stage II Gestational Trophoblastic Tumor Stage III Gestational Trophoblastic Tumor Invasive Mole Choriocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A prospective，multicenter，randomized trial with two arms

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm1-Methotrexate

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.

Group Type EXPERIMENTAL

Methotrexate

Intervention Type DRUG

50mg intramuscularly on Days 1, 3, 5, 7 . Repeat every 14 days

Leucovorin

Intervention Type DRUG

15mg intramuscularly on Days 2, 4, 6, 8. Repeat every 14 days

Arm 2-Dactinomycin

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.

Group Type EXPERIMENTAL

Dactinomycin

Intervention Type DRUG

1.25mg/m2 (2mg max dose)intravenous every 14 days.

Interventions

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Methotrexate

50mg intramuscularly on Days 1, 3, 5, 7 . Repeat every 14 days

Intervention Type DRUG

Leucovorin

15mg intramuscularly on Days 2, 4, 6, 8. Repeat every 14 days

Intervention Type DRUG

Dactinomycin

1.25mg/m2 (2mg max dose)intravenous every 14 days.

Intervention Type DRUG

Other Intervention Names

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MTX Calcium folinate dactinomycin D

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No