Combination of Methotrexate(MTX) and Actinomycin(ACTD) in the Low Risk Gestational Trophoblastic Neoplasma （GTN） Patients With Score of 5-6
Women's Hospital, Zhejiang University School of Medicine
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Weiguo Lu, MD.
- Phone Number: 86-13588819218
- Email: lbwg@zju.edu.cn
Study Contact Backup
- Name: Lili Chen, PhD.
- Phone Number: 86-13958138597
- Email: 5197004@zju.edu.cn
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310006
- Recruiting
- Weiguo Lv
-
Contact:
- Weiguo Lv, Doctor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control arm
single methotrexate multicourse treatment MTX:MTX 0.4mg/kg•d, intramuscular, every two weeks
|
multicourse methotrexate chemotherapy
Other Names:
|
|
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)
|
combination use of methotrexate and actinomycin
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
primary complete remission
Time Frame: 24 weeks
|
complete remission rate by primary treatment
|
24 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Weiguo Lu, MD., Women's Hospital, College of Medicine Zhejiang University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Germ Cell and Embryonal
- Pregnancy Complications
- Pregnancy Complications, Neoplastic
- Drug-Related Side Effects and Adverse Reactions
- Trophoblastic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Anti-Bacterial Agents
- Protein Synthesis Inhibitors
- Antibiotics, Antineoplastic
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Methotrexate
- Dactinomycin
Other Study ID Numbers
- CSEM 13b
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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