Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Trophoblastic Neoplasms

Choriocarcinoma

Nevus

Hydatidiform Mole, Invasive

Gestational Trophoblastic Disease

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Pregnancy Complications

Pregnancy Complications, Neoplastic

Urogenital Diseases

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

Gestational Trophoblastic Tumor

Micronutrients

All Drugs and Chemicals

Antineoplastic Agents

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Anti-Infective Agents

Bone Density Conservation Agents

Hematinics

Vitamins

Leucovorin

Levoleucovorin

Methotrexate

Calcium

Dactinomycin

Calcium, Dietary

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Trace Elements

Anti-Bacterial Agents

Antibiotics, Antitubercular

Folinic Acid

Folate

Vitamin B9

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.

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.

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

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

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

Yang Xiang

yang xiang

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.

A prospective，multicenter，randomized trial with two arms

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

A Prospective，Multicenter，Randomized Trial of Biweekly Single-dose Actinomycin-D Versus Multi-day Methotrexate Protocol for the Treatment of Low-risk Gestational Trophoblastic Neoplasia

Percentage of participants with complete response by single-agent chemotherapy. A complete response was defined as a normal hCG sustained over 3 weekly measurements.

Percentage of participants with complete response by single-agent chemotherapy and those by second line multiple-drug chemotherapy after single-agent failure

The duration needed to achieve complete remission after single-agent in two arms

The number of courses needed to achieve complete remission after single-agent chemotherapy in two arms

Incidence and severity of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 in two arms

Effects on menstrual conditions and ovarian function measured by Anti-Mullerian hormone（AMH）

xiang yang

the Director of Gynecological Oncology Center at Peking Union Medical College Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Biweekly Actinomycin-D Treatment or Multi-day Methotrexate Protocol in Low-risk Gestational Trophoblastic Neoplasia	NCT04562558	Gestational Tro... Gestational Tro... Stage I Gestati... Stage II Gestat... Stage III Gesta... Invasive Mole Choriocarcinoma	Methotrexate Leucovorin Dactinomycin	18 Years - 75 Years	Peking Union Medical College Hospital
Biweekly Actinomycin-D Treatment or Multi-day Methotrexate Protocol in Low-risk Gestational Trophoblastic Neoplasia	NCT04562558	Gestational Tro... Gestational Tro... Stage I Gestati... Stage II Gestat... Stage III Gesta... Invasive Mole Choriocarcinoma	Methotrexate Leucovorin Dactinomycin	18 Years - 75 Years	Peking Union Medical College Hospital

Spots Global Cancer Trial Database for stage i gestational trophoblastic tumor