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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Trophoblastic Disease

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    September 11, 2017
    Last Updated
    September 11, 2017
    Sponsor
    Assiut University
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    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

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    Rescue Regimen and High Dose Methotrexate in Management of Presistent Gestational Trophoplastic Neoplasia

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