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

Maher elesawi kamel elesawi

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Gestational Trophoblastic Neoplasms

Treatments: Procedure: Total abdominal hysterectomy and methotrexate; Drug: Methotrexate plus folinic acid alone

Study type: Interventional

Funder types: Other

Identifiers

NCT02606539

GTN and surgery

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 40+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

surgery and methotrxate

Active Comparator group

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

Treatment:

Procedure: Total abdominal hysterectomy and methotrexate

methotrxate

Active Comparator group

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

Treatment:

Drug: Methotrexate plus folinic acid alone