Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Gestational Trophoblastic Disease

Trophoblastic Neoplasms

Hydatidiform Mole

Choriocarcinoma

Nevus

Hydatidiform Mole, Invasive

Trophoblastic Tumor, Placental Site

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

François Golfier, Pr

Touria Hajri

The French Gestational Trophoblastic Disease (GTD) centre has been set up and active by registering, monitoring and treating women with GTD since november 1999. The aim is to improve the management of trophoblastic disease in France.

About 850 new cases are registered each year and 140 women treated, mostly with chemotherapy and surgery.

The center works as follow, based on a multidisciplinary approach. The policy is that patient remains followed by her local physician, but can be seen and treated in the Center at demand and that the registry is done on a voluntary basis.

Each administrative french area has a local expert team (oncologist and gynaecologist) who is able to look after the patients with the help of the national reference center physicians based in Lyon.

* Once a doctor discovers a molar pregnancy, he contacts the center, with the agreement of his patient, for an opinion, an advice or simply to report the case.
* The center sends to the doctor the informed consent form to be signed by the patient, a registering form and information about pathology for patient and physician, and first guidelines based on initial pathology report.

The patient remains followed by her gynecologist, who stays her first interlocutor throughout the whole process and she goes to her local laboratory for hCG monitoring;

* A letter is sent to the initial pathology laboratory that originally carried the diagnosis of molar pregnancy to require slide sending to the pathologist referral center (9 experts with a specific pathologist national network) that centrally review initial diagnosis.
* In the mean time, the data manager collects weekly hCG values to establish a follow-up chart. The physician is regularly informed by mail of the hCG evolution.
* The local physician is contacted in case of modification of the diagnosis by the pathologist expert. The center informs him about length and monitoring methodology.
* Emails or letters are sent at each step of the management (at inclusion, at hCG negativation, and at the end of hCG follow-up).
* In case of abnormal hCG evolution (raise, plateauing or positivity at 6 months,) or if a neoplasia is anatomopathologically diagnosed (choriocarcinoma, PSTT or ETT), physician is immediately contacted by phone or email by referent gynaecologist. A complete work up including pelvic US with Doppler, pelvic MRI, thoraco-abdominal CT-scan with chest radiography if pulmonary nodules are present and brain MRI, is planned to determine the adequate treatment.

Very briefly, based on imaging results, FIGO stade and score are calculated to determine the risk. In case of low-risk, a monochemotherapy is settled, while a polychemotherapy is started in case of high-risk disease.

The investigators have developped specific expertise at key levels of diagnosis, management, follow-up, fertility preservation and treatment.

Assignments :

* Registration and monitoring post diagnosis of complete or partial molar pregnancy, choriocarcinoma,PSTT, ETT, atypical placental site nodules
* Histopathological analysis and genetics services
* Measurement of human chorionic gonadotrophin (hCG) isoforms
* Complex gynaecological surgery

The French National Reference Centre of GTD

The French National Reference Centre of Gestational Trophoblastic Disease

trophoblastic deseases can be partial or complete molal pregnancy, choriocarcinoma, , placental site trophoblastic tumors (PSTT), epithelioid trophoblastic tumors (ETT), atypical placental site nodule.

Hospices Civils de Lyon

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Gestational Trophoblastic Tumor

Micronutrients

All Drugs and Chemicals

Antineoplastic Agents

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Hematinics

Anti-Infective Agents

Bone Density Conservation Agents

Vitamins

Leucovorin

Levoleucovorin

Methotrexate

Calcium

Folic Acid

Dactinomycin

Calcium, Dietary

Cactinomycin

Vitamin B Complex

Hormones

Antimetabolites

Enzyme Inhibitors

Folic Acid Antagonists

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Trace Elements

Anti-Bacterial Agents

Antibiotics, Antitubercular

Folinic Acid

Folate

Vitamin B9

Patients receive dactinomycin IV over 15 minutes on day 1.

Patients receive methotrexate IM on days 1, 3, 5, and 7 and leucovorin calcium PO on days 2, 4, 6, and 8 OR single agent methotrexate IV on days 1-5.

Leucovorin Calcium

Quality-of-Life Assessment

Julian C Schink

This randomized phase III trial studies how well methotrexate works compared to dactinomycin in treating patients with low-risk gestational trophoblastic neoplasia. Drugs used in chemotherapy, such as methotrexate and dactinomycin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether methotrexate is more effective than dactinomycin in treating gestational trophoblastic disease.

PRIMARY OBJECTIVES:

I. To test the hypothesis that treatment with multi-day methotrexate is inferior to treatment with pulse actinomycin-D (dactinomycin) in patients with low-risk gestational trophoblastic disease with respect to complete response.

SECONDARY OBJECTIVES:

I. To describe the frequency of post protocol surgical treatment for each arm. II. To describe the frequency of post protocol multi-agent chemotherapy treatment for each arm.

III. To compare multi-day methotrexate to actinomycin-D with respect to frequency and severity of adverse events in patients with low-risk gestational trophoblastic neoplasia.

IV. To investigate the impact of treatment on overall quality-of-life (QOL) and explore the influence of treatment on issues such as body image, sexual functioning, and patient-reported side effects and disruption.

V. To assess whether uterine artery pulsatility index (UAPI) can provide independent prognostic information predictive of single-drug resistance.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive dactinomycin intravenously (IV) over 15 minutes on day 1.

ARM II: Patients receive methotrexate intramuscularly (IM) on days 1, 3, 5, and 7 and leucovorin calcium orally (PO) on days 2, 4, 6, and 8 OR single agent methotrexate IV on days 1-5.

In both arms, treatment repeats every 14 days for up to 20 courses\* in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up monthly for 1 year and then every 3 months for 1 year.

NOTE: \* Patients will be treated for three courses after human chorionic gonadotropin (hCG) \< 5 mIU/mL or until evidence of treatment failure (biologic progression), disease progression, or unacceptable toxicity despite dose modifications. Upon normalization of hCG (\< 5 mIU/mL), patients will be treated with three additional courses.

Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia

A Phase III Randomized Trial of Pulse Actinomycin-D Versus Multi-day Methotrexate for the Treatment of Low-Risk Gestational Trophoblastic Neoplasia

Complete Response is defined as 3 consecutive bi-weekly values of hCG\<5 over a minimum of 4 weeks of normal hCG values with no values greater than 5 mIU/ml

Maximum grade of physician assessed adverse events reported during treatment

Patient reported quality of life was measured with the Functional Assessment of Cancer Therapy - Generic (FACT-G). The FACT-G is a scale for assessing general QOL of cancer patients. It consists of four subscales: Physical Well Being, Functional Well Being, Social/Family Well-Being, and Emotional Well-Being. Each item in the FACT-G was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements, reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The FACT-G score is calculated as the sum of the subscale scores. The FACT-G score ranges 0-108. A larger score suggests better QOL.

National Cancer Institute (NCI)

GOG Foundation

Participants listed in the all-cause mortality include all enrolled. Participants in the Serious Adverse Event and Other Adverse Events include all eligible AND treated. Therefore, the number of participants listed in the all-cause mortality is larger than the serious adverse event and other adverse event tables.

IV pulse actinomycin-D (1.25mg/m2 ) every 14 days. (2mg max dose)

Regimen I (Dactinomycin)

institutional preference of either:

* IV methotrexate (0.4 mg/kg) daily for 5 days every 14 days. (25mg max daily dose) OR
* IM methotrexate (50mg) on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days.

Regimen II (Methotrexate)

Total

10-19 years

20-29 years

30-39 years

40-49 years

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Early closure leading to non-compliance and small numbers of subjects analyzed. Study cannot be considered terminated because some participants are still being examined for follow-up.

Linda Gedeon for Virginia Filiaci, PhD.

Percentage of Participants With Complete Response

Grade 1

Grade 2

Grade 3

Grade 4

Grade 5

Number of Participants With CTCAE v4 Graded Adverse Events With Low-risk Gestational Trophoblastic Neoplasia by Arm

Non-responding eligible patients in follow-up

The Number of Participants With Post Protocol Surgical Treatment for Each Arm.

The Number of Participants With Post Protocol Multi-agent Chemotherapy Treatment for Each Arm.

Patient-reported Quality of Life (QOL) at Baseline

Pre-cycle 3

Pre-cycle 5

Pre-cycle 7

26 weeks

Provided baseline and ≥1 follow-up assessments

Patient-reported Quality of Life (QOL) After Baseline Visit.

Overall Study

Vasodilator Agents

Nitroglycerin

In single evacuation group women will be treated by suction evacuation and curettage is performed at the end of evacuation in one sitting. An ultrasound will be done later to examine completeness of evacuation. If there is significant amount of residual molar tissue or persistence of heavy bleeding a repeat curettage will be done . Women will be followed up with serum beta hcg 1 week after the evacuation and then weekly till the titer is negative. After three consecutive negative titre beat HCG estimation will be done at two weekly interval.

Suction and evacuation

In double evacuation group , women will be treated by suction evacuation and a thorough curettage will be avoided. A second evacuation with thorough curettage will be performed after 5 - 7 days of first evacuation.

Snehamay Chaudhuri, MD, DNB

Hydatidiform mole is a common complication of pregnancy with an incidence of 1in 400 pregnancies in India. Although this is a benign condition , it is having the malignant potential too. A repeat curettage after evacuation of hydatidiform mole was generally advocated till 1990s. A thorough curettage at the time of initial evacuation was not performed because of larger size of uterus and risk of perforation. Subsequently a number of studies assessed the usefulness of repeat curettage and found it was unnecessary and not cost effective . However all these studies are retrospective in design and conducted in developed countries where hydatidiform mole is diagnosed earlier because of wider use of ultrasonography. Thus there is a need to perform a well designed prospective study to compare the effectiveness of single evacuation with double evacuation in treatment of hydatidiform mole for prevention of Gestational Trophoblastic Neoplasia.This study compares the effectiveness of single evacuation versus double evacuation for treatment of hydatidiform mole for prevention of gestational trophoblastic neoplasia .

A Comparison of Single Versus Double Evacuation for Treatment of Hydatidiform Mole

A Comparison of Single Versus Double Evacuation for Treatment of Hydatidiform

Nilratan Sircar Medical College

Associate Professor,Obstetrics and Gynecology, NRS Medical College

This is a prospective observational study with no intervention

No intervention

Weiguo Lv, PhD

Xiao Li, PhD

The purpose of this study is to construct a cohort for the hydatidiform mole.

After being informed about the study and potential risks, all patients who meet the eligibility requirements will be enrolled.

Collect blood, and tissue samples from patients

A Cohort Study of Hydatidiform Mole

A Multi-center Cohort Study of Hydatidiform Mole

Patients with hydatidiform mole develop malignant trophoblastic tumor. The Federation of International of Gynecologists and Obstetricians criteria for diagnosis of postmolar gestational trophoblastic neoplasia were as follows: (1) when the plateau of human chorionic gonadotrophin (hCG) lasts for four measurements over a period of 3 weeks or longer; that is, days 1, 7, 14, 21; (2) when there is a rise in hCG for three consecutive weekly measurements over at least a period of 2 weeks or more; days 1, 7, 14; (3) If there is a histologic diagnosis of choriocarcinoma.

Women's Hospital School Of Medicine Zhejiang University

Anti-Inflammatory Agents

Analgesics

Chrysarobin

Liver Extracts

Chemoprohylaxis Group: the treatment group, will be given a single course of methotrexate within fourteen days from molar evacuation. Methotrexate will be given at 0.4 mg/kg intramuscularly per day for 5 days. No chemotherapy will be administered if the hemoglobin is lower than 10 g/L, WBC is less than 3.0 x 10 g/L or more than 10.0 x 10 g/L, absolute neutrophil count is less than 1.5, platelet count is lower than 100,000/cu.cc., patient has elevated liver and renal function test and has concurrent infection.

Control Group: will be given a placebo in a form of Vitamin B Complex (Bee ALL), intramuscularly or intravenously.

Patients will be given a single course of methotrexate within fourteen days from molar evacuation.

Patients will be given a placebo in a form of Vitamin B Complex (Bee ALL), intramuscularly or intravenously.

Agnes L. Soriano-Estrella, MD

A randomized, controlled trial to evaluate the efficacy of methotrexate for the prevention of postmolar gestational trophoblastic disease among patients with high-risk hydatidiform mole.

A randomized, controlled trial to evaluate the efficacy of methotrexate for the prevention of postmolar gestational trophoblastic disease among patients with high-risk hydatidiform mole.

Women who will undergo suction curettage for complete hydatidiform mole at the Philippine General Hospital, who are at risk for developing postmolar gestational trophoblastic disease will be included in the study. Patients will receive either a single course of methotrexate or vitamin B complex (Benutrex) within fourteen days from molar evacuation. Patients' serum beta HCG will be monitored 1 week after molar evacuation and then every 2 weeks until the titers become normal for three consecutive determinations, then monthly for 6 months (every 2 months for the next 6 months).

RCT on the Efficacy of Methotrexate for the Prevention of GTD

The Efficacy of Methotrexate for the Prevention of Postmolar Gestational Trophoblastic Disease Among Patients With High-Risk Hydatidiform Mole

1. Diagnosis of postmolar gestational trophoblastic diseases will be based on the occurrence of any of the following conditions:

   * high level of hCG more than 4 weeks post-evacuation (serum level of 20,000mlU/m)
   * progressively increasing or plateuing hCG values at any time after evacuation (minimum of 3 weekly determinations)
   * clinical or histologic evidence of metastasis at any site
   * persistently elevated hCG titer at 14 weeks post-evacuation
   * elevation of previously normal hCG titer after evacuation provided the diagnosis of pregnancy is excluded
2. Toxicity brought about by the administration of methotrexate will be graded based on the WHO toxicity scoring system.

University of the Philippines

Nervous System Diseases

Substance Related Disorders

Symptoms and General Pathology

Peripheral Nervous System Diseases

Neurotoxicity Syndromes

Syndrome

Neuromuscular Diseases

Poisoning

Chemically-Induced Disorders

Amifostine

Radiation-Protective Agents

amifostine trihydrate

Steven C. Plaxe, MD

RATIONALE: Amifostine may be effective in relieving numbness, tingling, and other symptoms of peripheral neuropathy. It is not yet known whether amifostine is effective in treating peripheral neuropathy in patients who have received chemotherapy for cancer.

PURPOSE: This randomized phase III trial is studying amifostine to see how well it works compared to observation in relieving numbness, tingling, and other symptoms of peripheral neuropathy in patients who have received platinum-based chemotherapy (such as cisplatin or carboplatin) for cancer.

OBJECTIVES:

* Determine, preliminarily, whether amifostine is superior to no treatment, in terms of improving the symptoms and/or objective findings of platinum-induced peripheral neuropathy, in patients with cancer.
* Determine the toxicity of this drug in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive amifostine IV or subcutaneously over 3 minutes on days 1, 3, and 5. Treatment continues for 12 weeks in the absence of unacceptable toxicity. Patients are observed for 12 weeks.
* Arm II: Patients are observed for 24 weeks. After 24 weeks patients may cross over to treatment as in arm I.

Quality of life is assessed at baseline and then at 6, 12, 18, and 24 weeks after study entry.

Patients are followed at 6 and 12 weeks after study treatment, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 50-100 patients (25-50 per treatment arm) will be accrued for this study.

Amifostine in Treating Peripheral Neuropathy in Patients Who Have Received Chemotherapy for Cancer

A Randomized Phase III Trial of Amifostine vs. No Treatment for Platinum Induced Peripheral Neuropathy

Gynecologic Oncology Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The French National Reference Centre of GTD	NCT02892877	Neoplasm, Troph... Gestational Tro... Hydatidiform Mo... Hydatidiform Mo...		-	Hospices Civils de Lyon
Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia	NCT01535053	Choriocarcinoma FIGO Stage I Ge... FIGO Stage II G... FIGO Stage III ... Hydatidiform Mo...	Dactinomycin Leucovorin Calc... Methotrexate Quality-of-Life...	18 Years -	GOG Foundation
A Comparison of Single Versus Double Evacuation for Treatment of Hydatidiform Mole	NCT01630954	Hydatidiform Mo...	Suction and eva... Suction and eva...	15 Years - 45 Years	Nilratan Sircar Medical College
A Cohort Study of Hydatidiform Mole	NCT05637892	Hydatidiform Mo...	No intervention	13 Years - 55 Years	Women's Hospital School Of Medicine Zhejiang University
RCT on the Efficacy of Methotrexate for the Prevention of GTD	NCT01984099	Hydatidiform Mo...	Methotrexate Vitamin B Compl...	35 Years -	University of the Philippines
Amifostine in Treating Peripheral Neuropathy in Patients Who Have Received Chemotherapy for Cancer	NCT00058071	Gestational Tro... Neurotoxicity Peripheral Neur... Unspecified Adu...	amifostine trih...	18 Years -	GOG Foundation
A Comparison of Single Versus Double Evacuation for Treatment of Hydatidiform Mole	NCT01630954	Hydatidiform Mo...	Suction and eva... Suction and eva...	15 Years - 45 Years	Nilratan Sircar Medical College
RCT on the Efficacy of Methotrexate for the Prevention of GTD	NCT01984099	Hydatidiform Mo...	Methotrexate Vitamin B Compl...	35 Years -	University of the Philippines
A Cohort Study of Hydatidiform Mole	NCT05637892	Hydatidiform Mo...	No intervention	13 Years - 55 Years	Women's Hospital School Of Medicine Zhejiang University
Amifostine in Treating Peripheral Neuropathy in Patients Who Have Received Chemotherapy for Cancer	NCT00058071	Gestational Tro... Neurotoxicity Peripheral Neur... Unspecified Adu...	amifostine trih...	18 Years -	GOG Foundation

Spots Global Cancer Trial Database for hydatidiform mole