- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03280979
Rescue Regimen and High Dose Methotrexate in Management of Presistent Gestational Trophoplastic Neoplasia
Comparison Between Rescue Regimen and High Dose Methotrexate in the Managment of Presistent Gestational Trophoplastic Neoplasia :( A Randomized Controlled Trial )
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
When reporting GTN data, it is useful to use both the FIGO anatomic staging system and prognostic scoring system . A FIGO score of 6 or less indicates low-risk GTN whereas a score of 7 or more identifies high-risk disease.
Table 1- FIGO Anatomical staging of gestational trophoblastic neoplasia:
Stage I Disease confined to the uterus Stage II Disease extends to the outside of the uterus, but is limited to the genital structures Stage III Disease extends to the lungs, with or without genital tract involvement Stage IV All other metastatic sites
Table 2- FIGO Scoring system:
FIGO SCORING 0 1 2 4 Age (years) Antecedent pregnancy Interval months from end of index pregnancy to treatment Pretreatment serum hCG (iu/l) Largest tumour size, including uterus Site of metastases Number of metastases Previous failed chemotherapy <40 ≥40 - - mole abortion term <4 4-6 7-12 >12 <1000 1000-10000 10000-100000 >100000 <3cm 3-4cm ≥5 - Lung spleen&kidney GIT liver&brain
- 1-4 5-8 >8
- - 1 drug 2 or more drugs
RCOG guidelines (No. 38February 2010 ) recommends the use of rescue regimen of alternating methotrexate( MTX) and leucoverin for 8 days (class D). However, several protocols using MTX were described. No prospective randomised controlled trials have been done to compare the efficacy of resue regimen with the ther protocols. In a retrospective study done showed that high dose methotrexate regimen is more effective than the rescue regimen.
In addition, several concerns have been raised towards the use of leucoverin with methotrexate, although reducing the side effects, however, it may increase the resistence to the effect of MTX .
On the other hand, High dose regimen offers a less hospital stay which may be more convenient to the patients, together with the same incidence of side effects.
In our study we are going to compare the efficacy and tolerance of both regimens in patients diagnosed to have low risk PGTN.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: zahraa magdy, md
- Phone Number: 01002603379
- Email: zahraamagdy92@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age: 18-50
- BW: 50-100 kg
- willing and consenting to be enrolled in the study
- Absence of active vaginal bleeding which requires surgical intervention • - WHO score <6
Exclusion Criteria:
- Renal and liver dysfunction or blood dyscariasis
- high risk persistent gestational trophoblastic disease.
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 |
---|---|
Experimental: study group1
In the rescue regimen , we administer MTX in an eight-day treatment regimen consisting of four administrations of MTX given at 1 mg/kg I.M. every other day with folinic acid 0.1 mg/kg I.M,.
given on intervening days.
|
In the rescue regimen , we administer MTX in an eight-day treatment regimen consisting of four administrations of TX given at 1 mg/kg I.M. every other day with folinic acid 0.1 mg/kg I.M,.
given on intervening days.
|
Experimental: study group2
In the high dose MTX protocol, the patients will receive 100 mg/m2 intravenous (IV) MTX bolus followed by 200 mg/m2IV MTX infused over 12 hours followed by folinic acid
|
In the high dose MTX protocol, the patients will receive 100 mg/m2 intravenous (IV) MTX bolus followed by 200 mg/m2IV MTX infused over 12 hours followed by folinic acid
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cure rate
Time Frame: 12 month
|
cure rate till B hcG is negative and then 2 consolidation regimens
|
12 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
decline in Bhcg
Time Frame: 12 month
|
Number of cycles for decline in BhCG
|
12 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
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
Other Study ID Numbers
- RR&HDMPGTN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- Study Protocol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gestational Trophoblastic Disease
-
GOG FoundationNational Cancer Institute (NCI)CompletedHydatidiform Mole | Choriocarcinoma | FIGO Stage I Gestational Trophoblastic Tumor | FIGO Stage II Gestational Trophoblastic Tumor | FIGO Stage III Gestational Trophoblastic TumorUnited States, Korea, Republic of, Canada, Japan, United Kingdom
-
xiang yangRecruitingGestational Trophoblastic Tumor | Gestational Trophoblastic Neoplasia | Choriocarcinoma | Stage I Gestational Trophoblastic Tumor | Stage II Gestational Trophoblastic Tumor | Stage III Gestational Trophoblastic Tumor | Invasive MoleChina
-
Ding MaShandong University; Huazhong University of Science and Technology; Zhejiang...UnknownGestational Trophoblastic Tumor | Gestational Trophoblastic Neoplasia | Gestational Trophoblastic Disease | Gestational Trophoblastic NeoplasmsChina
-
Gynecologic Oncology GroupNational Cancer Institute (NCI); Eastern Cooperative Oncology GroupCompletedHydatidiform Mole | Good Prognosis Metastatic Gestational Trophoblastic Tumor | Non-Metastatic Gestational Trophoblastic Tumor | Uterine Corpus ChoriocarcinomaUnited States
-
Weiguo LvShandong University; Huazhong University of Science and Technology; First Affiliated...RecruitingGestational Trophoblastic NeoplasmsChina
-
Hospices Civils de LyonCompletedGestational Trophoblastic Neoplasias (GTN)France
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedGestational Trophoblastic TumorUnited States, Norway
-
Brigham and Women's HospitalUniversidade Federal do Rio de Janeiro; Maternidade Escola da Universidade... and other collaboratorsRecruitingGestational Trophoblastic Neoplasia | Molar Pregnancy | Gestational Trophoblastic Tumor, Non-MetastaticBrazil
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedNon-Metastatic Gestational Trophoblastic Tumor | Complete Hydatidiform Mole | Partial Hydatidiform MoleUnited States, Canada
-
Hospices Civils de LyonNot yet recruitingImmune Checkpoint Inhibitors | Gestational Trophoblastic TumoursFrance
Clinical Trials on rescue regimen
-
Boston Medical CenterMerck Sharp & Dohme LLCRecruiting
-
Can Tho Stroke International Services HospitalCompletedThrombosis | Stent Stenosis | Ischemic Stroke, AcuteVietnam
-
University of North Carolina, CharlotteTeva Branded Pharmaceutical Products R&D, Inc.CompletedMultiple SclerosisUnited States
-
Medical University of SilesiaSilesian University of MedicineUnknown
-
Lallemand Pharma AGCompleted
-
Dr. Cuong Tran ChiRecruitingAcute Stroke | Ischemic Stroke, Acute | Vertebro Basilar IschemiaVietnam
-
University of Alabama at BirminghamNot yet recruiting
-
Assiut UniversityNot yet recruitingIschemic Stroke | Thromboembolic Stroke
-
First Affiliated Hospital Xi'an Jiaotong UniversityRecruitingVirus Diseases | Hepatitis B, ChronicChina
-
Charleston Research InstituteCompleted