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

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ClinicalTrials.gov Identifier: NCT03280979
Recruitment Status : Unknown
Verified September 2017 by Zahraa Magdy, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : September 13, 2017
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Zahraa Magdy, Assiut University

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

Condition or disease Intervention/treatment Phase
Gestational Trophoblastic Disease Drug: rescue regimen Drug: high dose methotrxate Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Rescue Regimen and High Dose Methotrexate in the Managment of Presistent Gestational Trophoplastic Neoplasia :( A Randomized Controlled Trial )
Estimated Study Start Date : October 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : October 2019


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.
Drug: rescue regimen
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
Drug: high dose methotrxate
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 Measures :
  1. cure rate [ Time Frame: 12 month ]
    cure rate till B hcG is negative and then 2 consolidation regimens


Secondary Outcome Measures :
  1. decline in Bhcg [ Time Frame: 12 month ]
    Number of cycles for decline in BhCG



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280979


Contacts
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Contact: zahraa magdy, md 01002603379 zahraamagdy92@yahoo.com

Sponsors and Collaborators
Assiut University

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Responsible Party: Zahraa Magdy, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03280979     History of Changes
Other Study ID Numbers: RR&HDMPGTN
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gestational Trophoblastic Disease
Neoplasms
Trophoblastic Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Pregnancy Complications, Neoplastic
Pregnancy Complications
Leucovorin
Folic Acid
Methotrexate
Levoleucovorin
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antidotes
Protective Agents
Vitamin B Complex
Vitamins