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Combination of Methotrexate(MTX) and Actinomycin(ACTD) in the Low Risk Gestational Trophoblastic Neoplasma (GTN) Patients With Score of 5-6

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ClinicalTrials.gov Identifier: NCT03885388
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Collaborators:
Huazhong University of Science and Technology
Qilu Hospital of Shandong University
West China Second University Hospital
Information provided by (Responsible Party):
Women's Hospital School Of Medicine Zhejiang University

Brief Summary:
In this study, a prospective, multicenter randomized controlled study was conducted to compare the clinical efficacy and toxicity response of combination MTX+ACTD multi-course regimen in low-risk GTN patients with score 5-6 with standard MTX single-drug multi-course regimen.

Condition or disease Intervention/treatment Phase
Gestational Trophoblastic Tumor Effects of Chemotherapy Drug Toxicity Drug: MTX Drug: MTX+ACTD Phase 2 Phase 3

Detailed Description:

The improved prognostic scoring system has been in use for more than 20 years in GTN patients. However, there are also more and more clinical evidences showing that the International Federation of Obstetrics and Gynecology(FIGO)/world health organization (WHO) system is not so perfect. The main problem is that a considerable number of patients are resistant to initial chemotherapy, 25-35% occur in low risk (≤ 6 points), and 70-80% occur in patients with a score of 5-6 points. According to reference, the drug resistance factors include high HCG level before chemotherapy, metastatic foci, histological diagnosis of choriocarcinoma, etc. However, according to the score before 2000, there is a moderate risk score group with 4-6 points, i.e. most of the single drug resistance to the initial regimen occurs in the previous moderate risk score group.Therefore, most scholars believe that there are grey areas with a score of 5-6. According to the analysis of 5-6 scores in the scoring system, the prognosis of single-drug chemotherapy is poor, and the initial remission rate is only about 30-40%. Therefore, many authors call for the current staging scoring system to be revised to a more accurate model so that some patients who may be drug resistant can adopt more effective plans at the beginning of treatment.

In this study, the investigators plan to conduct a prospective, multicenter randomized controlled study to compare the clinical efficacy and toxicity response of combination MTX+ACTD multi-course regimen in low-risk GTN patients with score 5-6 with standard MTX single-drug multi-course regimen. The experiment arm of the trial is multi-course combination of MTX and ACTD. The primary endpoint is complete remission rate of primary treatment or failure of primary treatment. Drug toxicity is surveillanced.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: treatment by combination of methotrexate and actinomycin
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Women's Hospital, Zhejiang University School of Medicine
Actual Study Start Date : March 8, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2023


Arm Intervention/treatment
Active Comparator: control arm
single methotrexate multicourse treatment MTX:MTX 0.4mg/kg•d, intramuscular, every two weeks
Drug: MTX
multicourse methotrexate chemotherapy
Other Name: methotrexate

Experimental: experimental arm
combination of methotrexate and actinomycin multicourse treatment, every two weeks MTX+ACTD:Act-d 0.6mg/m2 Day1,2 intravenous (IV) MTX 100mg/m2 IV Day1(after Act-d) MTX 200mg/m2 Ivgtt Day1(after MTX,500mlNS)
Drug: MTX+ACTD
combination use of methotrexate and actinomycin
Other Name: methotrexate+actinomycin




Primary Outcome Measures :
  1. primary complete remission [ Time Frame: 24 weeks ]
    complete remission rate by primary treatment



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of gestational trophoblastic tumor;
  • Patients with prognosis score of 5 and 6
  • Primary chemotherapy (preventive chemotherapy is not included);
  • Physical strength grade: Karnofsky score ≥ 60;
  • WBC ≥ 3.5× 109/L, ANC ≥ 1.5× 109/L, PT ≥ 80× 109/L, serum bilirubin ≤ 1.5 times of normal high limit, transaminase ≤ 1.5 times of normal high limit, BUN, Cr≤ normal;
  • Follow-up and good compliance;
  • Sign the informed consent form.

Exclusion Criteria:

  • Pathological diagnosis is intermediate trophoblastic tumor, including PSTT and ETT;
  • There are serious or uncontrollable medical diseases, which are not suitable for chemotherapy;
  • Those who receive clinical trials of other drugs at the same time.
  • Those who receive Chinese medicine.

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): NCT03885388


Contacts
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Contact: Weiguo Lu, MD. 86-13588819218 lbwg@zju.edu.cn
Contact: Lili Chen, PhD. 86-13958138597 5197004@zju.edu.cn

Locations
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China, Zhejiang
Weiguo Lv Recruiting
Hangzhou, Zhejiang, China, 310006
Contact: Weiguo Lv, Doctor         
Sponsors and Collaborators
Women's Hospital School Of Medicine Zhejiang University
Huazhong University of Science and Technology
Qilu Hospital of Shandong University
West China Second University Hospital
Investigators
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Study Chair: Weiguo Lu, MD. Women's Hospital, College of Medicine Zhejiang University

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Responsible Party: Women's Hospital School Of Medicine Zhejiang University
ClinicalTrials.gov Identifier: NCT03885388     History of Changes
Other Study ID Numbers: CSEM 13b
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Women's Hospital School Of Medicine Zhejiang University:
GTN
MTX
ACTD

Additional relevant MeSH terms:
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Trophoblastic Neoplasms
Gestational Trophoblastic Disease
Drug-Related Side Effects and Adverse Reactions
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Pregnancy Complications, Neoplastic
Pregnancy Complications
Chemically-Induced Disorders
Methotrexate
Dactinomycin
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
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
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Protein Synthesis Inhibitors