Surgery Plus Single Agent Chemotherapy Versus Primary Chemotherapy for Gestational Trophoblastic Neoplasms (SVCGTN)

March 21, 2017 updated by: Maher elesawi kamel elesawi

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt
        • Recruiting
        • Mansoura University Hospital
        • Sub-Investigator:
          • Maher E Kamel elesawi, MSc
    • Eldakahlia
      • Mit Ghamr, Eldakahlia, Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • chemotharapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of primary chemotherapy courses till B-hCG reach less than 5 MU/ML
Time Frame: 1-6 months
1-6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life( questionairre)
Time Frame: 1-6 months
pain scale from zero to 11, return to ordinary activities
1-6 months
complications from management
Time Frame: 1-6 months
renal, hepatic impairments, anemia,
1-6 months
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
1-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maher elesawi kamel elesawi

Investigators

  • Principal Investigator: Reda hemida, MD, Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

August 8, 2015

First Submitted That Met QC Criteria

November 16, 2015

First Posted (Estimate)

November 17, 2015

Study Record Updates

Last Update Posted (Actual)

March 22, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GTN and surgery

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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