Drug Toxicity, Effects of Chemotherapy, Gestational Trophoblastic Tumor
Conditions
Keywords
GTN, MTX, ACTD
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.
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.
Interventions
DRUGMTX
multicourse methotrexate chemotherapy
DRUGMTX+ACTD
combination use of methotrexate and actinomycin
Sponsors
Huazhong University of Science and Technology
Qilu Hospital of Shandong University
West China Second University Hospital
Women's Hospital School Of Medicine Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
treatment by combination of methotrexate and actinomycin
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| primary complete remission | 24 weeks | complete remission rate by primary treatment |
Countries
China
Contacts
Primary ContactWeiguo Lu, MD.
Backup ContactLili Chen, PhD.
Outcome results
None listed