Rescue Regimen and High Dose Methotrexate in Management of Presistent Gestational Trophoplastic Neoplasia
Primary Purpose
Gestational Trophoblastic Disease
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
rescue regimen
high dose methotrxate
Sponsored by
About this trial
This is an interventional treatment trial for Gestational Trophoblastic Disease
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
study group1
study group2
Arm Description
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 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
Outcomes
Primary Outcome Measures
cure rate
cure rate till B hcG is negative and then 2 consolidation regimens
Secondary Outcome Measures
decline in Bhcg
Number of cycles for decline in BhCG
Full Information
NCT ID
NCT03280979
First Posted
September 11, 2017
Last Updated
September 11, 2017
Sponsor
Assiut University
1. Study Identification
Unique Protocol Identification Number
NCT03280979
Brief Title
Rescue Regimen and High Dose Methotrexate in Management of Presistent Gestational Trophoplastic Neoplasia
Official Title
Comparison Between Rescue Regimen and High Dose Methotrexate in the Managment of Presistent Gestational Trophoplastic Neoplasia :( A Randomized Controlled Trial )
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2017 (Anticipated)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Gestational trophoblastic neoplasia (GTN) are malignant lesions that arise from abnormal proliferation of placental trophoblast. The pathologic conditions that make up this entity include invasive partial and complete hydatidiform mole, choriocarcinoma, placental site trophoblastic tumor (PSTT), and epithelioid trophoblastic tumor (ETT). GTN often arises after molar pregnancies but can also occur after any gestation including miscarriages and term pregnancies. In the United States, hydatidiform moles are observed in approximately 1/600 therapeutic abortions and 1/1000-2000 pregnancies . Most cases of GTN are diagnosed when the serum hCG levels plateau or rise in patients being observed after the diagnosis of hydatidiform mole.These malignancies are highly susceptible to chemotherapy and it is often possible to achieve cure while preserving the woman's reproductive function
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Trophoblastic Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study group1
Arm Type
Experimental
Arm Description
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.
Arm Title
study group2
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
rescue regimen
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
high dose methotrxate
Intervention Description
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
Primary Outcome Measure Information:
Title
cure rate
Description
cure rate till B hcG is negative and then 2 consolidation regimens
Time Frame
12 month
Secondary Outcome Measure Information:
Title
decline in Bhcg
Description
Number of cycles for decline in BhCG
Time Frame
12 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zahraa magdy, md
Phone
01002603379
Email
zahraamagdy92@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Rescue Regimen and High Dose Methotrexate in Management of Presistent Gestational Trophoplastic Neoplasia
We'll reach out to this number within 24 hrs