Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
Study NCT ID:
NCT04562558
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-11
First Post:
2020-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biweekly Actinomycin-D Treatment or Multi-day Methotrexate Protocol in Low-risk Gestational Trophoblastic Neoplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D031901', 'term': 'Gestational Trophoblastic Disease'}, {'id': 'D002820', 'term': 'Hydatidiform Mole, Invasive'}, {'id': 'D002822', 'term': 'Choriocarcinoma'}], 'ancestors': [{'id': 'D014328', 'term': 'Trophoblastic Neoplasms'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D011252', 'term': 'Pregnancy Complications, Neoplastic'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D006828', 'term': 'Hydatidiform Mole'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D003609', 'term': 'Dactinomycin'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A prospective，multicenter，randomized trial with two arms'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 228}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2020-09-13', 'studyFirstSubmitQcDate': '2020-09-18', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completely remission (CR) rate by single-agent', 'timeFrame': 'from date of treatment begin until the data serum hCG is normal for 3 consecutive weeks by single-agent chemotherapy，assessed up to 8 months', 'description': 'Percentage of participants with complete response by single-agent chemotherapy. A complete response was defined as a normal hCG sustained over 3 weekly measurements.'}, {'measure': 'Overall completely remission rate', 'timeFrame': 'from date of treatment begin until the data serum hCG is normal for 3 consecutive weeks by single-agent chemotherapy or multi-agent chemotherapy，assessed up to 12 months', 'description': 'Percentage of participants with complete response by single-agent chemotherapy and those by second line multiple-drug chemotherapy after single-agent failure'}], 'secondaryOutcomes': [{'measure': 'The duration needed to achieve complete remission after single-agent chemotherapy', 'timeFrame': 'from date of treatment begin until the data serum hCG is normal for 3 consecutive weeks by single-agent chemotherapy，assessed up to 8 months', 'description': 'The duration needed to achieve complete remission after single-agent in two arms'}, {'measure': 'The number of courses needed to achieve complete remission after single-agent chemotherapy', 'timeFrame': 'from date of treatment begin until the data serum hCG is normal for 3 consecutive weeks by single-agent chemotherapy，assessed up to 8 months', 'description': 'The number of courses needed to achieve complete remission after single-agent chemotherapy in two arms'}, {'measure': 'Incidence of Adverse Effects (Grade 3 or Higher)', 'timeFrame': 'through study completion, an average of 3 year', 'description': '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'}, {'measure': 'Effects on menstrual conditions and ovarian function', 'timeFrame': 'Prior to treatment begin，and 6 month after single-agent chemotherapy completion, an average of 2 year', 'description': 'Effects on menstrual conditions and ovarian function measured by Anti-Mullerian hormone（AMH）'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gestational trophoblastic neoplasia', 'actinomycin-D', 'methotrexate', 'low-risk'], 'conditions': ['Gestational Trophoblastic Tumor', 'Gestational Trophoblastic Neoplasia', 'Stage I Gestational Trophoblastic Tumor', 'Stage II Gestational Trophoblastic Tumor', 'Stage III Gestational Trophoblastic Tumor', 'Invasive Mole', 'Choriocarcinoma']}, 'referencesModule': {'references': [{'pmid': '40543844', 'type': 'DERIVED', 'citation': 'Jiang F, Guan CL, Jiao LZ, Xu T, Wan XR, Shi SS, Wu BB, Zhang X, Zhen L, Miao JW, Tian M, Du M, Li C, Feng FZ, Yang JJ, Ren T, Zhao J, Li Y, Zhang XQ, Lu X, Xiang Y. Efficacy and safety of biweekly single-dose actinomycin D versus multiday methotrexate in low-risk gestational trophoblastic neoplasia: a prospective multicenter randomized trial. Ann Oncol. 2025 Oct;36(10):1123-1131. doi: 10.1016/j.annonc.2025.06.006. Epub 2025 Jun 19.'}, {'pmid': '37612621', 'type': 'DERIVED', 'citation': 'Jiang F, Mao MY, Xiang Y, Lu X, Guan CL, Jiao LZ, Wan XR, Feng FZ, Ren T, Yang JJ, Zhao J. Comparing biweekly single-dose actinomycin D with multiday methotrexate therapy for low-risk gestational trophoblastic neoplasia (FIGO Score 0-4): study protocol for a prospective, multicentre, randomized trial. BMC Cancer. 2023 Aug 23;23(1):784. doi: 10.1186/s12885-023-11225-2.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven low-risk gestational trophoblastic neoplasia (persistent hydatidiform mole or choriocarcinoma), defined as 1 of the following:\n\n * Less than 10% decrease in the beta human chorionic gonadotropin (HCG) titer over 3 weekly titers\n * Greater than 20% sustained rise in beta HCG titer over two consecutive weeks\n * Histologically proven choriocarcinoma\n* Stage I - III disease\n* WHO risk score 0-4\n* No prior chemotherapy for gestational trophoblastic neoplasia\n* Signed informed consent\n* Performance status - GOG 0-2\n* 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\n\nExclusion Criteria:\n\n* Histologically confirmed placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)\n* primary choriocarcinoma\n* WHO risk score \\>4\n* Previous MTX treatment for suspected ectopic pregnancy\n* With severe or uncontrolled internal disease, unable to receive chemotherapy;\n* Concurrently participating in other clinical trials\n* Unable or unwilling to sign informed consents;\n* Unable or unwilling to abide by protocol.'}, 'identificationModule': {'nctId': 'NCT04562558', 'briefTitle': 'Biweekly Actinomycin-D Treatment or Multi-day Methotrexate Protocol in Low-risk Gestational Trophoblastic Neoplasia', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'PUMCH-LRGTN-SINGLE DRUG-0222'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm1-Methotrexate', '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.', 'interventionNames': ['Drug: Methotrexate', 'Drug: Leucovorin']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2-Dactinomycin', '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.', 'interventionNames': ['Drug: Dactinomycin']}], 'interventions': [{'name': 'Methotrexate', 'type': 'DRUG', 'otherNames': ['MTX'], 'description': '50mg intramuscularly on Days 1, 3, 5, 7 . Repeat every 14 days', 'armGroupLabels': ['Arm1-Methotrexate']}, {'name': 'Leucovorin', 'type': 'DRUG', 'otherNames': ['Calcium folinate'], 'description': '15mg intramuscularly on Days 2, 4, 6, 8. Repeat every 14 days', 'armGroupLabels': ['Arm1-Methotrexate']}, {'name': 'Dactinomycin', 'type': 'DRUG', 'otherNames': ['dactinomycin D'], 'description': '1.25mg/m2 (2mg max dose)intravenous every 14 days.', 'armGroupLabels': ['Arm 2-Dactinomycin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'yang xiang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'xiang yang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'the Director of Gynecological Oncology Center at Peking Union Medical College Hospital', 'investigatorFullName': 'xiang yang', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}