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

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ClinicalTrials.gov Identifier: NCT04562558
Recruitment Status : Recruiting
First Posted : September 24, 2020
Last Update Posted : November 16, 2021
Sponsor:
Information provided by (Responsible Party):
xiang yang, Peking Union Medical College Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gestational Trophoblastic Tumor Gestational Trophoblastic Neoplasia Stage I Gestational Trophoblastic Tumor Stage II Gestational Trophoblastic Tumor Stage III Gestational Trophoblastic Tumor Invasive Mole Choriocarcinoma Drug: Methotrexate Drug: Leucovorin Drug: Dactinomycin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A prospective,multicenter,randomized trial with two arms
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 29, 2020
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2025


Arm Intervention/treatment
Experimental: 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.
Drug: Methotrexate
50mg intramuscularly on Days 1, 3, 5, 7 . Repeat every 14 days
Other Name: MTX

Drug: Leucovorin
15mg intramuscularly on Days 2, 4, 6, 8. Repeat every 14 days
Other Name: Calcium folinate

Experimental: 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.
Drug: Dactinomycin
1.25mg/m2 (2mg max dose)intravenous every 14 days.
Other Name: dactinomycin D




Primary Outcome Measures :
  1. Completely remission (CR) rate by single-agent [ Time Frame: 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 ]
    Percentage of participants with complete response by single-agent chemotherapy. A complete response was defined as a normal hCG sustained over 3 weekly measurements.

  2. Overall completely remission rate [ Time Frame: 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 ]
    Percentage of participants with complete response by single-agent chemotherapy and those by second line multiple-drug chemotherapy after single-agent failure


Secondary Outcome Measures :
  1. The duration needed to achieve complete remission after single-agent chemotherapy [ Time Frame: 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 ]
    The duration needed to achieve complete remission after single-agent in two arms

  2. The number of courses needed to achieve complete remission after single-agent chemotherapy [ Time Frame: 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 ]
    The number of courses needed to achieve complete remission after single-agent chemotherapy in two arms

  3. Incidence of Adverse Effects (Grade 3 or Higher) [ Time Frame: through study completion, an average of 3 year ]
    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

  4. Effects on menstrual conditions and ovarian function [ Time Frame: Prior to treatment begin,and 6 month after single-agent chemotherapy completion, an average of 2 year ]
    Effects on menstrual conditions and ovarian function measured by Anti-Mullerian hormone(AMH)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
    • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04562558


Contacts
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Contact: Yang Xiang 86-010-69155635 xiangy@Pumch.cn

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Yang Xiang    01069156068    XiangY@pumch.cn   
Sponsors and Collaborators
xiang yang
Investigators
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Study Director: yang xiang Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences
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Responsible Party: xiang yang, the Director of Gynecological Oncology Center at Peking Union Medical College Hospital, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04562558    
Other Study ID Numbers: PUMCH-LRGTN-SINGLE DRUG-0222
First Posted: September 24, 2020    Key Record Dates
Last Update Posted: November 16, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by xiang yang, Peking Union Medical College Hospital:
gestational trophoblastic neoplasia
actinomycin-D
methotrexate
low-risk
Additional relevant MeSH terms:
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Neoplasms
Choriocarcinoma
Trophoblastic Neoplasms
Gestational Trophoblastic Disease
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Pregnancy Complications, Neoplastic
Pregnancy Complications
Leucovorin
Dactinomycin
Methotrexate
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antidotes