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

Drug Toxicity Clinical Trial

Official title:

Women's Hospital, Zhejiang University School of Medicine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03885388
• Other study ID #: CSEM 13b
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: March 8, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2019
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: Weiguo Lu, MD.
• Phone: 86-13588819218
• Email: lbwg[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Toxicity
• Drug-Related Side Effects and Adverse Reactions
• Effects of Chemotherapy
• Gestational Trophoblastic Disease
• Gestational Trophoblastic Tumor
• Trophoblastic Neoplasms

Intervention

Drug:
• MTX
multicourse methotrexate chemotherapy
• MTX+ACTD
combination use of methotrexate and actinomycin

Locations

Country	Name	City	State
China	Weiguo Lv	Hangzhou	Zhejiang

Sponsors (4)

Lead Sponsor	Collaborator
Women's Hospital School Of Medicine Zhejiang University	Huazhong University of Science and Technology, Qilu Hospital of Shandong University, West China Second University Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	primary complete remission	complete remission rate by primary treatment	24 weeks