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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    300
  • sponsor
    Women's Hospital School Of Medicine Zhejiang University
Updated on 23 January 2021

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 GynecologyFIGO/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.

Details
Condition overdose of drug with toxic effect, Gestational trophoblastic disease, Diet and Nutrition, Chronic Diarrhea, Skin Wounds, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, Effects of Chemotherapy, Peripheral Arterial Occlusive Disease, Brain Function, Recurrent Respiratory Papillomatosis, Razor Bumps (Pseudofolliculitis Barbae), Metastatic Triple-Negative Breast Cancer, Gestational Trophoblastic Neoplasia, drug toxicity
Treatment MTX, MTX+ACTD
Clinical Study IdentifierNCT03885388
SponsorWomen's Hospital School Of Medicine Zhejiang University
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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
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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
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