Methotrexate Single-dose Treatment and Methotrexate/Actinomycin-D Single-dose Treatment in Low-Risk Gestational Trophoblastic Neoplasia (GTN-01)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Huazhong University of Science and Technology
Sponsor:
Collaborators:
Zhejiang University
Huazhong University of Science and Technology
Shandong University
Information provided by (Responsible Party):
Ding Ma, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01823315
First received: March 21, 2013
Last updated: March 29, 2013
Last verified: March 2013
  Purpose

The investigators will conduct a trial to determine whether methotrexate single-dose treatment and methotrexate/Actinomycin-D single-dose treatment work well as multiple courses of single agent chemotherapy in low-risk gestational trophoblastic neoplasia.


Condition Intervention Phase
Gestational Trophoblastic Disease
Gestational Trophoblastic Neoplasia
Gestational Trophoblastic Tumor
Gestational Trophoblastic Neoplasms
Drug: MTX 1
Drug: MTX 2
Biological: Act-d
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Prospective, Randomized Trial of Methotrexate Single-dose Treatment and Methotrexate/Actinomycin-D Single-dose Treatment in Low-Risk Gestational Trophoblastic Neoplasia

Resource links provided by NLM:


Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:
  • Severity of adverse events as assessed by the WHO [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    It is difficult to estimate the exact cycles of chemotherapy,we may calculate the rate of complete response and the rate of treatment failure at the preliminary end point of the trail.

  • Progression-Free Survival (PFS) [ Time Frame: 1-year ] [ Designated as safety issue: No ]
  • Complete response vs treatment failure [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    It is difficult to estimate the exact cycles of chemotherapy,we may calculate the rate of complete response and the rate of treatment failure at the preliminary end point of the trail.


Secondary Outcome Measures:
  • Resume menstruation [ Time Frame: at the time the first resume menstruation after treatment completed ] [ Designated as safety issue: No ]
  • The pregnancy rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    to calculate the pregnancy rate in an actuarial manner using the Kaplan-Meier method at the end of the trail

  • the delivery rate with at least one live born baby [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    to calculate the delivery rate in an actuarial manner using the Kaplan-Meier method at the end of the trail

  • The incidence of abnormal pregnancy [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    to observe the incidence of abnormal pregnancy i.e., stillbirths, neonatal deaths, miscarriages before 14 weeks, miscarriages after 14 weeks, terminations, ectopic pregnancy, molar pregnancy.


Estimated Enrollment: 300
Study Start Date: December 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MTX Single-dose chemotherapy
Methotrexate (MTX) 0.4mg/(kg·d) intramuscularly (IM) on days 1-5; If β-hCG level can not drop to 1/10 of the origin level during the following 3 weeks, additional course is administered at 2-week intervals, after the first normal hCG value has been recorded.
Drug: MTX 1
MTX 0.4mg/(kg·d) intramuscularly (IM) on days 1-5
Experimental: MTX/Act-d Single-dose chemotherapy
Act-d 0.6mg/m(2), IV, on day1,2; MTX 100mg/m(2), IV, on day1 (after Act-d); MTX 200mg/m(2), IVgtt, on day1 (after MTX, 500ml NS, >4h); If β-hCG level can not drop to 1/10 of the origin level during the following 3 weeks, additional course is administered at 2-week intervals, after the first normal hCG value has been recorded.
Drug: MTX 2
MTX 100mg/m(2), IV, on day1 (after Act-d); MTX 200mg/m(2), IVgtt, on day1 (after MTX, 500ml NS, >4h)
Biological: Act-d
Act-d 0.6mg/m(2), IV, on day1,2
Active Comparator: MTX multiple courses chemotherapy

MTX 0.4mg/(kg·d) intramuscularly (IM) on days 1-5, 2-week intervals;

1 cycle of chemotherapy should be given after the first normal hCG level.

Drug: MTX 1
MTX 0.4mg/(kg·d) intramuscularly (IM) on days 1-5

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who FIGO Stage I, II, or III criteria for low-risk gestational trophoblastic neoplasia (GTN);
  • WHO risk score 0-6;
  • Age≤60 years; female, Chinese women;
  • Initial treatment is chemotherapy; patients who received prior low-dose methotrexate for treatment of an ectopic pregnancy will be eligible for this study;
  • Performance status: Karnofsky score≥60;
  • Laboratory tests: WBC≥3.5×10(9)/L, ANC≥1.5×10(9)/L, PLT≥80×10(9)/L, serum bilirubin≤ 1.5 times the upper limit of normal, transaminase≤ 1.5 times the upper limit of normal, BUN, Cr≤ normal
  • Provide written informed consent.

Exclusion Criteria:

  • Patients with unconfirmed diagnosis of GTN;
  • Patients with placental-site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT)
  • WHO risk score >6;
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01823315

Contacts
Contact: Danhui Weng, MD, PhD +862783662681 weng.dh@gmail.com

Locations
China, Hubei
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430030
Contact: Danhui Weng, MD    +862783662681    weng.dh@gmail.com   
Principal Investigator: Ling Xi, MD         
China, Shandong
Qilu Hospital,Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Jie Jiang, MD, Ph D    13791123139    qljiangjie@yahoo.cn   
Principal Investigator: Jie Jiang, MD         
China, Zhejiang
Women's Hospital, School of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310006
Contact: Lili Chen, MD    13958138597    chenglili-@163.com   
Principal Investigator: Lili Chen, MD         
Sponsors and Collaborators
Ding Ma
Zhejiang University
Huazhong University of Science and Technology
Shandong University
Investigators
Study Chair: Xing Xie, MD, PhD Zhejiang University
  More Information

No publications provided

Responsible Party: Ding Ma, Director of the department of Obstetrics and Gynecology, Tongji Hospital, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT01823315     History of Changes
Other Study ID Numbers: 2012-GYN/GTN-01
Study First Received: March 21, 2013
Last Updated: March 29, 2013
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Pregnancy Complications, Neoplastic
Neoplasms
Trophoblastic Neoplasms
Gestational Trophoblastic Neoplasms
Hydatidiform Mole
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Pregnancy Complications
Dactinomycin
Methotrexate
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Dermatologic Agents
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 24, 2014