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Trial record 1 of 3 for:    "Gestational Trophoblastic Neoplasm" | "Calcium"
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Surgery Plus Single Agent Chemotherapy Versus Primary Chemotherapy for Gestational Trophoblastic Neoplasms (SVCGTN)

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ClinicalTrials.gov Identifier: NCT02606539
Recruitment Status : Unknown
Verified November 2015 by Maher elesawi kamel elesawi, Mansoura University.
Recruitment status was:  Recruiting
First Posted : November 17, 2015
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
Maher elesawi kamel elesawi, Mansoura University

Brief Summary:
Gestational trophoblastic neoplasm affect women and is sensitive to chemotherapy especially methotrexate and the investigators try to find a role of surgery plus methotrexate instead of multiple doses and cycles of chemotherapy.

Condition or disease Intervention/treatment Phase
Gestational Trophoblastic Neoplasms Procedure: Total abdominal hysterectomy and methotrexate Drug: Methotrexate plus folinic acid alone Phase 2 Phase 3

Detailed Description:
Gestational trophoblastic neoplasm affect women and is sensitive to chemotherapy espechialy methotrexate and the investigators try to find a role of surgery plus mehotrexate instead of multiple doses and cycles of chemotherapy that affect the patient quality of life and complication related to both line of management and time of decrease of B-hcg.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Primary Surgery Plus Single Course Methotrexate Versus Primary Methotrexate for Treatment of Gestational Trophoblastic Neoplasms in Low Risk Cases Above 40y: a Randomized Controled Trial
Study Start Date : September 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : August 2017


Arm Intervention/treatment
Active Comparator: surgery and methotrxate
The patient will be treated by total abdominal hystrectomy(after written consent laparatomy will be done then pelvic examination for extra uterine spread, palpation of liver, omentum for any gross lesions and then hystrectomt bilateral salpigooophrectomy will be done) plus single course methotrexate(anti folate chemotheraputic agent, vial form given by intramuscular injection) 1mg/kg alternating with calcium folinate 0.1 mg/kg until normalization of B-HCG
Procedure: Total abdominal hysterectomy and methotrexate
After written consent laparotomy will be done then pelvic examination for extra uterine spread, palpation of liver, omentum for any gross lesions and then hystrectomt bilateral salpigooophrectomy will be done) plus single course methotrexate(anti folate chemotheraputic agent, vial form given by intramuscular injection) 1mg/kg every other day alternating with calcium folinate 0.1 mg/kg for 4 doses each cycle then measuring B-HCG (the cycle may be repeated until normalization of B-HCG)
Other Name: surgery and chemotherapy

Active Comparator: methotrxate
The patient will be treated by multiple courses of methotrexate( antifolate) 1mg/kg every 14 days each one alternating in every otherday with calcium folinate 0.1 mg/kg till normalization of B-HCG
Drug: Methotrexate plus folinic acid alone
methotrxate 1mg/kg every other day alternating with calcium folinate 0.1 mg/kg for 4 doses each cycle then measuring B-HCG and cycle repeated until normalization of B-HCG
Other Name: chemotharapy




Primary Outcome Measures :
  1. number of primary chemotherapy courses till B-hCG reach less than 5 MU/ML [ Time Frame: 1-6 months ]

Secondary Outcome Measures :
  1. quality of life( questionairre) [ Time Frame: 1-6 months ]
    pain scale from zero to 11, return to ordinary activities

  2. complications from management [ Time Frame: 1-6 months ]
    renal, hepatic impairments, anemia,

  3. time interval for B-hCG reach less than 5 MU/ML [ Time Frame: 1-6 months ]
    the time taken for B-hCG to reach below 5 MU/ML



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • females
  • 40 years or more
  • plateau or rising B- hCG titre
  • without distant metastasis
  • WHO score is less than 7

Exclusion Criteria:

  • less than 40 years
  • distant metastasis to lung and liver
  • chronic medical diseases
  • WHO score is more than 7

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): NCT02606539


Contacts
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Contact: maher elesawi, Msc 01016103662 maherelesawi@yahoo.com

Locations
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Egypt
Mansoura University Hospital Recruiting
Mansoura, Dakahlia, Egypt
Sub-Investigator: Maher E Kamel elesawi, MSc         
Maher Elesawi Kamel Elesawi Recruiting
Mit Ghamr, Eldakahlia, Egypt
Contact: Maher Elesawi, MD student    01016103662    maherelesawi@yahoo.com   
Contact: Reda Hemida, MD    01008622573    redaelshouky@hotmail.com   
Sponsors and Collaborators
Maher elesawi kamel elesawi
Investigators
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Principal Investigator: Reda hemida, MD Mansoura University

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Responsible Party: Maher elesawi kamel elesawi, assistant lecturer, Mansoura University
ClinicalTrials.gov Identifier: NCT02606539     History of Changes
Other Study ID Numbers: GTN and surgery
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: November 2015

Keywords provided by Maher elesawi kamel elesawi, Mansoura University:
gestaional trophoblastic neoplasm
hystrectomy
chemotherapy
methotrxate

Additional relevant MeSH terms:
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Gestational Trophoblastic Disease
Calcium
Calcium, Dietary
Calcium-Regulating Hormones and Agents
Neoplasms
Trophoblastic Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Pregnancy Complications, Neoplastic
Pregnancy Complications
Methotrexate
Leucovorin
Levoleucovorin
Folic Acid
Physiological Effects of Drugs
Bone Density Conservation Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
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