Drug Toxicity Clinical Trial
Official title:
Women's Hospital, Zhejiang University School of Medicine
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03265613 -
Safety and Efficacy of Expanded Allogeneic AD-MSCs in Patients With Moderate to Severe Psoriasis
|
Phase 1/Phase 2 | |
Recruiting |
NCT04696081 -
Atrial Fibrillation in Active Cancer Patients
|
||
Active, not recruiting |
NCT03651778 -
GHB Poisoning and Poisoning Induced by Others
|
||
Completed |
NCT04120233 -
MW151-101: First-in-human Study of MW151
|
Phase 1 | |
Recruiting |
NCT01965275 -
High-Dose,Pulsatile Erlotinib/Gefitinib for Advanced NSCLC Patients After Failure of Standard Dose EGFR-TKIs
|
Phase 2 | |
Completed |
NCT01614080 -
Outcome of Patients Treated by iv Rt-PA for Cerebral Ischaemia According to the Ratio Sc-tPA/Tc-tPA
|
N/A | |
Recruiting |
NCT04659343 -
TDM for Optimized Outcome in Patients With mRCC.
|
||
Completed |
NCT02864030 -
PAINTER: Polymorphism And INcidence of Toxicity in ERibulin Treatment
|
Phase 4 | |
Completed |
NCT01135680 -
Double-Blind Randomized Crossover Trial to Access Electrocardiogram Effects of HPN-100
|
Phase 1 | |
Completed |
NCT03947034 -
Monitoring the Hyperammonaemia:TOXicity of Drugs (AmmoTOX)
|
||
Completed |
NCT00491595 -
Phase I Clinical Study of Soy Isoflavones in Healthy, Post-Menopausal Women
|
Phase 1 | |
Recruiting |
NCT03469063 -
Impact of AferBio® on Quality of Life and Chemotherapy Toxicity in Lung Cancer Patients
|
N/A | |
Not yet recruiting |
NCT04671589 -
Antidote for Valproic Acid Toxicity: a New Indication for Meropenem Antibiotic.
|
Phase 4 | |
Completed |
NCT03280368 -
Adherence and Coagulation Assays in Dabigatran-treated Patients With Atrial Fibrillation
|
||
Withdrawn |
NCT01374061 -
Pre Hospital Evaluation of Video Laryngoscopy
|
Phase 4 | |
Completed |
NCT03994302 -
Monitoring the Antiphospholipid Syndrome:TOXicity of Drugs (APSTOX)
|
||
Completed |
NCT03392311 -
Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment in Patients With Moderate to Severe Psoriasis
|
Phase 1/Phase 2 | |
Terminated |
NCT00090844 -
Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer
|
Phase 2 | |
Terminated |
NCT00213642 -
Tc-99m Renography and Cisplatin-induced Nephrotoxicity
|
N/A | |
Recruiting |
NCT05022797 -
Reduction of MTX Levels After Glucarpidase Treatment in DLBCL Patients at Risk of CNS
|
Phase 2 |