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

Primary Purpose

Gestational Trophoblastic Neoplasms

Status

Unknown status

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Total abdominal hysterectomy and methotrexate

Methotrexate plus folinic acid alone

About this trial

This is an interventional treatment trial for Gestational Trophoblastic Neoplasms focused on measuring gestaional trophoblastic neoplasm, hystrectomy, chemotherapy, methotrxate

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Mansoura University HospitalRecruiting
Maher Elesawi Kamel ElesawiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

surgery and methotrxate

methotrxate

Arm Description

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

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

Outcomes

Primary Outcome Measures

number of primary chemotherapy courses till B-hCG reach less than 5 MU/ML

Secondary Outcome Measures

quality of life( questionairre)

pain scale from zero to 11, return to ordinary activities

complications from management

renal, hepatic impairments, anemia,

time interval for B-hCG reach less than 5 MU/ML

the time taken for B-hCG to reach below 5 MU/ML

Full Information

NCT ID

NCT02606539

First Posted

August 8, 2015

Last Updated

March 21, 2017

Sponsor

Maher elesawi kamel elesawi

1. Study Identification

Unique Protocol Identification Number

NCT02606539

Brief Title

Surgery Plus Single Agent Chemotherapy Versus Primary Chemotherapy for Gestational Trophoblastic Neoplasms

Acronym

SVCGTN

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 Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Unknown status

Study Start Date

September 2015 (undefined)

Primary Completion Date

June 2017 (Anticipated)

Study Completion Date

August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Maher elesawi kamel elesawi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gestational Trophoblastic Neoplasms

Keywords

gestaional trophoblastic neoplasm, hystrectomy, chemotherapy, methotrxate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

surgery and methotrxate

Arm Type

Active Comparator

Arm Description

Arm Title

methotrxate

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Total abdominal hysterectomy and methotrexate

Other Intervention Name(s)

surgery and chemotherapy

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

Methotrexate plus folinic acid alone

Other Intervention Name(s)

chemotharapy

Intervention Description

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

Primary Outcome Measure Information:

Title

number of primary chemotherapy courses till B-hCG reach less than 5 MU/ML

Time Frame

1-6 months

Secondary Outcome Measure Information:

Title

quality of life( questionairre)

Description

pain scale from zero to 11, return to ordinary activities

Time Frame

1-6 months

Title

complications from management

Description

renal, hepatic impairments, anemia,

Time Frame

1-6 months

Title

time interval for B-hCG reach less than 5 MU/ML

Description

the time taken for B-hCG to reach below 5 MU/ML

Time Frame

1-6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

maher elesawi, Msc

Phone

01016103662

maherelesawi@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Reda hemida, MD

Organizational Affiliation

Mansoura University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mansoura University Hospital

City

Mansoura

State/Province

Dakahlia

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maher E Kamel elesawi, MSc

Facility Name

Maher Elesawi Kamel Elesawi

City

Mit Ghamr

State/Province

Eldakahlia

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maher Elesawi, MD student

Phone

01016103662

maherelesawi@yahoo.com

First Name & Middle Initial & Last Name & Degree

Reda Hemida, MD

Phone

01008622573

redaelshouky@hotmail.com

12. IPD Sharing Statement

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Surgery Plus Single Agent Chemotherapy Versus Primary Chemotherapy for Gestational Trophoblastic Neoplasms

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