Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Trophoblastic Neoplasms

Gestational Trophoblastic Disease

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Pregnancy Complications

Pregnancy Complications, Neoplastic

Urogenital Diseases

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

Gestational Trophoblastic Tumor

Micronutrients

All Drugs and Chemicals

Antineoplastic Agents

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Hematinics

Bone Density Conservation Agents

Vitamins

Leucovorin

Levoleucovorin

Methotrexate

Calcium

Folic Acid

Liver Extracts

Vitamin B Complex

Calcium, Dietary

Folic Acid Antagonists

Antimetabolites

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Trace Elements

Folinic Acid

Folate

Vitamin B9

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

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)

Total abdominal hysterectomy and methotrexate

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

Methotrexate plus folinic acid alone

maher elesawi, Msc

Maher E Kamel elesawi, MSc

Maher Elesawi, MD student

Reda Hemida, MD

Reda hemida, MD

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.

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.

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

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

pain scale from zero to 11, return to ordinary activities

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

Maher elesawi kamel elesawi

assistant lecturer

Anti-Infective Agents

Dactinomycin

Regimen: Methotrexate 0.4mg/(kg·d) intramuscularly (IM) on days 1-5. If 10-fold fall of hCG achieved 18 days after treatment completion, success of primary single-course chemotherapy was defined and further treatment was withheld; otherwise, failure was defined and the patient was referred to multi-course chemotherapy. During the period of observation for those with success, if the level of hCG became stationary for at least 3 weeks or rose again, the patient was also referred to multi-course chemotherapy. Additional consolidation chemotherapy with 1-3 courses was given for those who achieved CR by multi-course chemotherapy, but not by single-course regimen.

Regimen: dactinomycin d 0.6mg/m2, IV, on day1, 2; methotrexate 100mg/m2, IV, on day1 (after Act-d); methotrexate 200mg/m2, IVgtt, on day1 (after methotrexate, 500ml NS, \>4h).

If 10-fold fall of hCG achieved 18 days after treatment completion, success of primary single-course chemotherapy was defined and further treatment was withheld; otherwise, failure was defined and the patient was referred to multi-course chemotherapy. During the period of observation for those with success, if the level of hCG became stationary for at least 3 weeks or rose again, the patient was also referred to multi-course chemotherapy. Additional consolidation chemotherapy with 1-3 courses was given for those who achieved CR by multi-course chemotherapy, but not by single-course regimen.

Regimen: methotrexate 0.4mg/(kg·d) intramuscularly (IM) on days 1-5, 2-week intervals. Patients continue on treatment until 1 beta HCG titer is below the institutional normal. Patients then receive at least 1 additional consolidation treatment.

After treatment, all the patients were asked for contraception with condom or oral contraception. Regular hCG surveillance, once a month for 3 consecutive months and once every 3 months for 2 years, was performed. During follow-up period, pelvic ultrasound and pulmonary X ray or CT scan were conducted if needed.

MTX 0.4mg/(kg·d) intramuscularly (IM) on days 1-5

MTX 1

MTX 100mg/m(2), IV, on day1 (after Act-d); MTX 200mg/m(2), IVgtt, on day1 (after MTX, 500ml NS, \>4h)

MTX 2

Act-d

Xing Xie, MD, PhD

The investigators conducted a trial to determine whether methotrexate or methotrexate/dactinomycin single-course treatment work well as multiple courses of single methotrexate chemotherapy in low-risk gestational trophoblastic neoplasia. It is not yet known whether single-course of chemotherapy is as the same effectiveness as multicourse.

Methotrexate Single-dose Treatment and Methotrexate/Actinomycin-D Single-dose Treatment in Low-Risk Gestational Trophoblastic Neoplasia

A Multicenter, Prospective, Randomized Trial of Methotrexate Single-dose Treatment and Methotrexate/Actinomycin-D Single-dose Treatment in Low-Risk Gestational Trophoblastic Neoplasia

Zhejiang University

Huazhong University of Science and Technology

Shandong University

Ding Ma

Director of the department of Obstetrics and Gynecology, Tongji Hospital

Etoposide

Paclitaxel

Cyclophosphamide

Carboplatin

Albumin-Bound Paclitaxel

Vincristine

Cisplatin

Etoposide phosphate

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

etoposide, methotrexate ,actinomycin D,vincristine, cyclophosphamide(EMA-CO), two weeks a cycle

paclitaxel + cisplatin or carboplatin，two weeks a cycle

etoposide 100mg/m2 ivgtt started at the first day of cycle, two weeks a cycle

actinomycin D 500ug ivgtt, started at the first day of cycle, two weeks a cycle

actinomycin D

methotrexate 100mg/m2, 200mg/m2, ivgtt, tetrahydrofolic acid （FA) 15mg q12h\*4(24h after methotrexate injection),started at the first day of cycle, two weeks a cycle

methotrexate

vincristine 1mg/m2 started at the 8th day of cycle, two weeks a cycle

vincristine

cyclophosphamide 600mg/m2, started at the 8th day of cycle, two weeks a cycle

cyclophosphamide

paclitaxel 135mg/m2, started at the first day of cycle, two weeks a cycle

cisplatin 50mg/m2, started at the first day of cycle, two weeks a cycle

carboplatin area under curve (AUC)=4-5, started at the first day of cycle, two weeks a cycle,as a substitute drug for cisplatin

Lu Weiguo, Doctor

Weiguo Lv, Doctor

This clinical trial is designed to study the effect and safety of paclitaxel plus cisplatin as the first-line regimen in the treatment of high risk gestational trophoblastic tumor.

Gestational trophoblastic tumor (GTN) is a group of malignant tumors derived from placental trophoblastic cells, most of which occur in women of reproductive age. The survival rate of patients with score of 7 or more points, or WHO Ⅳ period for high-risk patients was of 60% to 80%. However, due to severe toxic reactions, long treatment time, loss of optimal reproductive age and increased costs, and treatment failure caused by chemotherapy resistance, high-risk GTN is still one of the tumors seriously affecting the life health and quality of life of young women.

First-line chemotherapy recommended by FIGO is regimen of EMA - CO with corresponding side effects and adverse factors in the following aspects as relatively higer incidence of myelosupression, VP - 16 being associated with a second tumor, especially leukemia, and a definite effect of cyclophosphamide on the failure ovarian function Taxol (Taxol) is the most widely used and most effective broad-spectrum anti-tumor drug in gynecological malignant tumors at present, and T (paclitaxel) +P (platinum drugs) scheme is the first-line chemotherapy scheme in ovarian cancer patients at present. According to references, TP also has effects on resistant and refactory high risk GTN patients.

Given relatively simple operation way of TP chemotherapy, and the effect of chemotherapy in recurrence and high-risk refractory GTN performance,this prospective multicenter randomized controlled clinical research was to study the effect and safety of paclitaxel plus cisplatin as the first-line regimen in the treatment of high risk gestational trophoblastic tumor compared with EMA-CO.

Study of Paclitaxel Plus Cisplatin as the First-line Chemotherapy in High Risk Gestational Trophoblastic Tumor

A Prospective Randomized Multicenter Clinical Control Study of Paclitaxel Plus Cisplatin as the First-line Chemotherapy in High Risk Gestational Trophoblastic Tumor

We may calculate the rate of complete response and the rate of treatment failure at the preliminary end point of the trail.

We calculate the adverse events during and after chemotherapy.

We calculate the overall survival rate of high risk GTN patients after chemotherapy.

We may test serum level of anti-mullerian hormone (AMH) every 6 months and the time of menstrual cycle resuming after chemotherapy.

To calculate the pregnancy rate in an actuarial manner using the Kaplan-Meier method at the end of the trail

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Surgery Plus Single Agent Chemotherapy Versus Primary Chemotherapy for Gestational Trophoblastic Neoplasms	NCT02606539	Gestational Tro...	Total abdominal... Methotrexate pl...	40 Years -	Mansoura University
Methotrexate Single-dose Treatment and Methotrexate/Actinomycin-D Single-dose Treatment in Low-Risk Gestational Trophoblastic Neoplasia	NCT01823315	Gestational Tro... Gestational Tro... Gestational Tro... Gestational Tro...	MTX 1 MTX 2 Act-d	18 Years - 60 Years	Huazhong University of Science and Technology
Surgery Plus Single Agent Chemotherapy Versus Primary Chemotherapy for Gestational Trophoblastic Neoplasms	NCT02606539	Gestational Tro...	Total abdominal... Methotrexate pl...	40 Years -	Mansoura University
Study of Paclitaxel Plus Cisplatin as the First-line Chemotherapy in High Risk Gestational Trophoblastic Tumor	NCT02639650	Gestational Tro...	Etoposide actinomycin D methotrexate vincristine cyclophosphamid... Paclitaxel Cisplatin Carboplatin	- 60 Years	Women's Hospital School Of Medicine Zhejiang University

Spots Global Cancer Trial Database for gestational trophoblastic neoplasms