NCT02606539

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2015

Completed
24 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 17, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

March 22, 2017

Status Verified

November 1, 2015

Enrollment Period

1.8 years

First QC Date

August 8, 2015

Last Update Submit

March 21, 2017

Conditions

Gestational Trophoblastic Neoplasms

Keywords

gestaional trophoblastic neoplasmhystrectomychemotherapymethotrxate

Outcome Measures

Primary Outcomes (1)

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

    1-6 months

Secondary Outcomes (3)

  • quality of life( questionairre)

    1-6 months

  • complications from management

    1-6 months

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

    1-6 months

Study Arms (2)

surgery and methotrxate

ACTIVE COMPARATOR

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

methotrxate

ACTIVE COMPARATOR

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

Interventions

Total abdominal hysterectomy and methotrexatePROCEDURE

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)

Also known as: surgery and chemotherapy
surgery and methotrxate
Methotrexate plus folinic acid aloneDRUG

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

Also known as: chemotharapy
methotrxate

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, Egypt

RECRUITING

Maher Elesawi Kamel Elesawi

Mīt Ghamr, Eldakahlia, Egypt

RECRUITING

MeSH Terms

Conditions

Gestational Trophoblastic Disease

Interventions

MethotrexateSurgical Procedures, OperativeDrug TherapyLeucovorin

Condition Hierarchy (Ancestors)

Trophoblastic NeoplasmsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsPregnancy Complications, NeoplasticPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTherapeuticsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidCoenzymesEnzymes and Coenzymes

Study Officials

  • Reda hemida, MD

    Mansoura University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

maher elesawi, Msc

CONTACT

01016103662maherelesawi@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

August 8, 2015

First Posted

November 17, 2015

Study Start

September 1, 2015

Primary Completion

June 1, 2017

Study Completion

August 1, 2017

Last Updated

March 22, 2017

Record last verified: 2015-11

Locations

EG(2)