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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

Tracking Information
First Submitted Date  ICMJE September 13, 2020
First Posted Date  ICMJE September 24, 2020
Last Update Posted Date November 16, 2021
Actual Study Start Date  ICMJE September 29, 2020
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2020)
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2020)
  • 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
  • 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
  • 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
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Biweekly Actinomycin-D Treatment or Multi-day Methotrexate Protocol in Low-risk Gestational Trophoblastic Neoplasia
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
A prospective,multicenter,randomized trial with two arms
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gestational Trophoblastic Tumor
  • Gestational Trophoblastic Neoplasia
  • Stage I Gestational Trophoblastic Tumor
  • Stage II Gestational Trophoblastic Tumor
  • Stage III Gestational Trophoblastic Tumor
  • Invasive Mole
  • Choriocarcinoma
Intervention  ICMJE
  • 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
  • Drug: Dactinomycin
    1.25mg/m2 (2mg max dose)intravenous every 14 days.
    Other Name: dactinomycin D
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Methotrexate
    • Drug: Leucovorin
  • 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.
    Intervention: Drug: Dactinomycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 18, 2020)
176
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yang Xiang 86-010-69155635 xiangy@Pumch.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04562558
Other Study ID Numbers  ICMJE PUMCH-LRGTN-SINGLE DRUG-0222
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party xiang yang, Peking Union Medical College Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE xiang yang
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: yang xiang Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences
PRS Account Peking Union Medical College Hospital
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP