Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Trophoblastic Neoplasms

Choriocarcinoma

Nevus

Hydatidiform Mole, Invasive

Gestational Trophoblastic Disease

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

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

Anti-Infective Agents

Bone Density Conservation Agents

Hematinics

Vitamins

Leucovorin

Levoleucovorin

Methotrexate

Calcium

Dactinomycin

Calcium, Dietary

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Trace Elements

Anti-Bacterial Agents

Antibiotics, Antitubercular

Folinic Acid

Folate

Vitamin B9

Patients receive methotrexate intramuscularly（50mg） on Days 1, 3, 5, 7 (4 doses per cycle) with Leucovorin (15mg) on Days 2, 4, 6, 8. Repeat every 14 days. Patients continue on treatment until beta HCG titer is below the institutional normal. Patients then receive 2-3 additional consolidation treatment. If the level of hCG become stationary for at least 2 course of single-agent chemotherapy or rise again, the patient will be referred to multi-course chemotherapy. FAV regimen is preferred, or EMA-CO regimen can also be selected if FAV is unavailable.

Patients will receive IV pulse actinomycin-D (1.25mg/m2，2mg max dos) every 14 days. Patients continue on treatment until beta HCG titer is below the institutional normal. Patients then receive 2-3 additional consolidation treatment.If the level of hCG become stationary for at least 2 course of single-agent chemotherapy or rise again, the patient will be referred to multi-course chemotherapy. FAV regimen is preferred, or EMA-CO regimen can also be selected if FAV is unavailable.

50mg intramuscularly on Days 1, 3, 5, 7 . Repeat every 14 days

15mg intramuscularly on Days 2, 4, 6, 8. Repeat every 14 days

1.25mg/m2 (2mg max dose)intravenous every 14 days.

Yang Xiang

yang xiang

The investigators conducted a randomized trial to study how well multi-day methotrexate protocol works compared to biweekly single-dose actinomycin D protocol in treating patients with low-risk gestational trophoblastic neoplasia. It is not yet known whether multi-day methotrexate protocol is as effective as biweekly single-dose actinomycin D protocol in treating patients with gestational trophoblastic neoplasia.

A prospective，multicenter，randomized trial with two arms

Biweekly Actinomycin-D Treatment or Multi-day Methotrexate Protocol in Low-risk Gestational Trophoblastic Neoplasia

A Prospective，Multicenter，Randomized Trial of Biweekly Single-dose Actinomycin-D Versus Multi-day Methotrexate Protocol for the Treatment of Low-risk Gestational Trophoblastic Neoplasia

Percentage of participants with complete response by single-agent chemotherapy. A complete response was defined as a normal hCG sustained over 3 weekly measurements.

Percentage of participants with complete response by single-agent chemotherapy and those by second line multiple-drug chemotherapy after single-agent failure

The duration needed to achieve complete remission after single-agent in two arms

The number of courses needed to achieve complete remission after single-agent chemotherapy in two arms

Incidence and severity of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 in two arms

Effects on menstrual conditions and ovarian function measured by Anti-Mullerian hormone（AMH）

xiang yang

the Director of Gynecological Oncology Center at Peking Union Medical College Hospital

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Digestive System Diseases

Breast Neoplasms

Carcinoma, Ovarian Epithelial

Uterine Cervical Neoplasms

Vaginal Neoplasms

Vulvar Neoplasms

Sarcoma

Fallopian Tube Neoplasms

Endometrial Neoplasms

Peritoneal Neoplasms

Germinoma

Ovarian Neoplasms

Breast Diseases

Skin Diseases

Neoplasms, Connective and Soft Tissue

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Fallopian Tube Diseases

Adnexal Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Endocrine System Diseases

Gonadal Disorders

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Vulvar Diseases

Vaginal Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Vaginal Cancer

Soft Tissue Sarcoma

Germ Cells Tumors

Fallopian Tube Cancer

Vulvar Cancer

Ovarian Germ Cell Tumor

Uterine Sarcoma

Central Nervous System Germinoma

Patients participate in enhanced standard care intervention comprising stress reduction, information delivery regarding cancer treatments and sexuality delivered over two sessions.

Patients participate in individual or group therapy over 1.5 hours weekly for 6 weeks, bi-weekly for 8 weeks, and monthly for 2 months and complete assessment interviews.

behavioral, psychological or informational intervention

Participate in psychological intervention

Kristen M. Carpenter, Ph.D

This randomized phase II trial studies how well psychosexual intervention works in patients with stage I-III gynecologic or breast cancer. Psychosexual intervention may improve sexual and psychosocial function.

PRIMARY OBJECTIVES:

I. Efficacy for reducing the severity of sexual distress, difficulty, and dysfunction in a phase II randomized clinical trial (RCT).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (Enhanced standard care): Patients participate in enhanced standard care intervention comprising stress reduction, information delivery regarding gynecologic or breast cancer treatments and sexuality, and provision of a survivorship care plan (SCP) created using OncoLink over 1 hour following baseline assessment and before 6 months.

ARM II (Psychological intervention): Patients participate in individual or group therapy over 1.5 hours weekly for 4 weeks, bi-weekly for 8 weeks, and monthly for 2 months and complete assessment interviews.

After completion of study treatment, patients are followed up at 3, 6, and 9 months.

Psychosexual Intervention in Patients With Stage I-III Gynecologic or Breast Cancer

Psychosexual Intervention for Gynecologic and Breast Cancer Patients

Multilevel modeling will be used to model time effects compared to repeated-measures analysis of variance (ANOVA) because it allows not only fitting different patterns of average change (i.e., linear, quadratic), but also estimates individual variability in the rate of change. Both linear and quadratic change models will be tested and an optimal model will be determined. 95% confidence intervals will be obtained.

Principal components analysis yields six subscales: desire, arousal, lubrication, orgasm, satisfaction, and pain. Items are rated using the Likert scales. 95% confidence intervals will be obtained.

95% confidence intervals will be obtained.

The Likert scale will be used. 95% confidence intervals will be obtained.

The eight primary subscales are summarized into two component scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).

National Cancer Institute (NCI)

Ohio State University Comprehensive Cancer Center

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Biweekly Actinomycin-D Treatment or Multi-day Methotrexate Protocol in Low-risk Gestational Trophoblastic Neoplasia	NCT04562558	Gestational Tro... Gestational Tro... Stage I Gestati... Stage II Gestat... Stage III Gesta... Invasive Mole Choriocarcinoma	Methotrexate Leucovorin Dactinomycin	18 Years - 75 Years	Peking Union Medical College Hospital
Biweekly Actinomycin-D Treatment or Multi-day Methotrexate Protocol in Low-risk Gestational Trophoblastic Neoplasia	NCT04562558	Gestational Tro... Gestational Tro... Stage I Gestati... Stage II Gestat... Stage III Gesta... Invasive Mole Choriocarcinoma	Methotrexate Leucovorin Dactinomycin	18 Years - 75 Years	Peking Union Medical College Hospital
Psychosexual Intervention in Patients With Stage I-III Gynecologic or Breast Cancer	NCT01764802	Ovarian Sarcoma Ovarian Stromal... Stage I Uterine... Stage I Vaginal... Stage I Vulvar ... Stage IA Cervic... Stage IA Endome... Stage IA Fallop... Stage IA Ovaria... Stage IA Ovaria... Stage IA Primar... Stage IB Cervic... Stage IB Endome... Stage IB Fallop... Stage IB Ovaria... Stage IB Ovaria... Stage IB Primar... Stage IC Fallop... Stage IC Ovaria... Stage IC Ovaria... Stage IC Primar... Stage II Endome... Stage II Gestat... Stage II Uterin... Stage II Vagina... Stage II Vulvar... Stage IIA Cervi... Stage IIA Fallo... Stage IIA Ovari... Stage IIA Ovari... Stage IIA Prima... Stage IIB Cervi... Stage IIB Fallo... Stage IIB Ovari... Stage IIB Ovari... Stage IIB Prima... Stage IIC Fallo... Stage IIC Ovari... Stage IIC Ovari... Stage IIC Prima... Stage III Gesta... Stage III Uteri... Stage III Vagin... Stage III Vulva... Stage IIIA Cerv... Stage IIIA Endo... Stage IIIA Fall... Stage IIIA Ovar... Stage IIIA Ovar... Stage IIIA Prim... Stage IIIB Cerv... Stage IIIB Endo... Stage IIIB Fall... Stage IIIB Ovar... Stage IIIB Ovar... Stage IIIB Prim... Stage IIIC Endo... Stage IIIC Fall... Stage IIIC Ovar... Stage IIIC Ovar... Stage IIIC Prim... Breast Cancer	behavioral, psy... behavioral, psy...	21 Years - 80 Years	Ohio State University Comprehensive Cancer Center

Spots Global Cancer Trial Database for stage ii gestational trophoblastic tumor