Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

YM155

D. Buell, MD

A study with YM155 for the treatment of unresectable stage III or metastatic stage IV melanoma.

A phase II, multicenter, open-label study in subjects with unresectable Stage III or metastatic (Stage IV) Melanoma to evaluate the efficacy and safety of YM155

A Study for the Treatment of Unresectable Stage III or Metastatic Stage IV Melanoma

A Phase II, Multicenter, Open-Label Study of YM155 in Subjects With Unresectable Stage III or Metastatic (Stage IV) Melanoma

Astellas Pharma US, Inc.

Astellas Pharma Inc

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Hormones

A study for the treatment of hormone refractory prostate cancer (HRPC) in patients previously treated with chemotherapy.

A Study for the Treatment of Hormone Refractory Prostate Cancer (HRPC) in Patients Previously Treated With Chemotherapy

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Neoplasms, Glandular and Epithelial

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Medical Director

A study for the treatment of Non-Small Cell Lung Cancer (NSCLC) in patients previously treated with chemotherapy.

LUCY: A Study for the Treatment of Non-Small Cell Lung Cancer (NSCLC) in Patients Previously Treated With Chemotherapy

Disclosure Office Europe

Behaviors and Mental Disorders

Erectile Dysfunction

Sexual Dysfunction, Physiological

Sexual Dysfunctions, Psychological

Mental Disorders

Psychotic Disorders

Tacrolimus

Immunosuppressive Agents

Immunologic Factors

Calcineurin Inhibitors

Enzyme Inhibitors

Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.

Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.

Placebo

Central Contact

The purpose of the study is to compare the safety and effectiveness of Prograf in the prevention of erectile dysfunction in men after a radical prostatectomy.

The purpose of the study is to compare the safety and efficacy of Prograf versus placebo in the prevention of erectile dysfunction in men after a bilateral nerve-sparing radical prostatectomy.

A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction After Radical Prostatectomy

A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Prograf (Tacrolimus, FK 506) for the Prevention of Erectile Dysfunction Following Bilateral Nerve-sparing Radical Prostatectomy

Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The erectile function domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. The scores range from 1 to 30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.

Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The erectile function domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. The scores range from 1 to 30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.

Percentages represent the proportions of participants who achieved normal erectile function at any time during the 24 months.

Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The EF domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. Scores range from 1-30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.Time to achieve normalization of the EF domain score was calculated based on the date of the assessment during which the EF domain score was first greater than or equal to 24.

Patients were identified as successful responders if they answered affirmatively in the Patient Sexual Encounter Diary regarding successful sexual intercourse after using impotence medication.

Time to achieve response to impotence medication was calculated based on the date of the assessment during which the first successful response was recorded. The specific date of the actual response is not reflected; only that it occurred since the previous study visit.

Part 1 Urinary Function- Prostate Health-Related Quality-of-Life (QOL) Questionnaire consists of 16 questions asking patients about their continence and urinary habits over the previous four weeks. The responses to all 16 of these questions were added together to calculate an overall score for urinary function. The minimum possible score is 16 and the maximum possible score is 79. A higher score indicates a lower continence level.

Sr Manager Clinical Trial Registries

Serious Adverse Events possibly related to study drug were collected.

The only other Adverse Events collected were those associated with study drug dose changes.

Subjects who experienced an Adverse Event with the same preferred term multiple times were only counted once.

Total

Age Continuous

Sex: Female, Male

American Indian or Alaskan Native

Black or African American

White

Race/Ethnicity, Customized

Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.

Senior Medical Director, Medical Affairs

A group sequential design using the O'Brien and Fleming stopping rule will require 58 evaluable patients per group to detect a 5-point difference in the Erectile Function domain of the IIEF with a power of 80% and an overall significance level of 5%.

The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.

Only participants with complete IIEF questionnaire data at 18 months are included in the calculation.

Erectile Function Domain Score Between Treated and Untreated Groups

The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.

Percentage of Patients Achieving Normal Spontaneous Erectile Function as Measured by the Erectile Function (EF) Domain Score

The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.

Only participants who achieved normal erectile function are included in the calculation.

Time Taken to Achieve Normalization of the Erectile Function (EF) Domain Score

The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.

Only participants who used any impotence medications were included in the calculation.

Percentage of Patients Considered Successful Responders to Impotence Medications

The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.

Only participants who had a successful response to impotence medications were included in the calculations.

Time to Achieve Response to Impotence Medications

The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.

Only participants with a Prostate Health-Related QOL questionnaire at 24 months were included in the calculation.

Continence Level as Quantified by Part I of the Prostate Health-Related Quality of Life Questionnaire

Overall Study

Blood and Lymph Conditions

Uterine Cervical Neoplasms

Endometrial Neoplasms

Lymphedema

Lymphatic Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Prophylactic lymphedema treatment：The lymphedema prophylaxis treatment consists of four parts:manual lymphatic drainage, skin care, functional exercise, and wearing lymphedema preventive compression stockings.

The prophylactic lymphedema treatment group receives lymphedema prophylaxis twice a week for a total of 10 sessions, each requiring an interval of at least 48 hours but no more than 2 weeks.

Standard of care，includeIn knowledge education and telephone follow-up were routinely conducted.

1. perform manual lymphatic drainage twice a week after the start of radiotherapy for a total of 10 times, and wear lymphedema compression stockings after each manual lymphatic drainage, 2. teach patients how to care for their skin. 3. perform functional exercises for lymphedema of the lower extremities twice a day for 15 \~ 20 minutes each time. 4. follow up observation: before the start of radiotherapy, every Friday during radiotherapy, and every 3 months after the end of radiotherapy, the occurrence of lymphedema and related symptoms and quality of life were evaluated.

Prophylactic lymphedema treatment

Dongling Zou, Doctor

Dongling Zou, M.D.

This study is a prospective, randomized, controlled clinical trial of a single center in China and plans to enroll 400 patients.

1. Patients with diagnosed gynecological malignancies who underwent pelvic and abdominal lymphadenectomy and required pelvic radiotherapy;
2. Random grouping (A:B=3:1): A. Prophylactic lymphoedema treatment; B. Standard care group;
3. Preventive lymphedema health education was given to patients with gynecological malignant tumors without contraindications before surgery. All patients were randomly divided into an intervention group and a nonintervention group. The intervention group received preventive lymphedema treatment twice a week. 10 times, and the interval between the two treatments was not less than 48 hours and not more than 2 weeks. The intervention measures included four parts: manual lymphatic drainage, skin care, functional exercise, and wearing lymphedema preventive compression stockings. In the nonintervention group, knowledge education and telephone follow-up were routinely conducted.
4. All patients were evaluated for edema, lymphedema symptoms and quality of life 1 day before radiotherapy, every Friday during radiotherapy and every 3 months thereafter. Bioelectrical impedance measurement and leg diameter measurement were used to evaluate edema, the Gynecologic Cancer Lymphedema Questionnaire (GCLQ) was used to evaluate lymphedema symptoms, and the EORTC Quality of Life Scale (QLQ-C30) was used to evaluate quality of life. followed up to 2 years after the end of lymphedema prophylaxis.

Research background Gynecological malignancies, including cervical cancer, ovarian cancer, endometrial cancer, vulvar cancer, etc., are important diseases threatening women's health worldwide, and their main treatment methods are surgery and radiotherapy. During surgery, different numbers of lymph nodes are removed, and lymphatic fluid and tissue exudate from the stump lymphatic vessels accumulate, causing disruption of the original lymphatic circulation and obstruction of lymphatic fluid return, which leads to lower limb edema . The longer the radiotherapy lasts, the more serious the phenomenon of collateral circulation will be, and the lymphatic return pathway will be damaged, resulting in lower limb lymphedema .

Lower extremity lymphedema is a relatively common complication after treatment for gynecologic malignancies, and it has been reported that approximately 20 million patients worldwide are affected by lower extremity lymphedema. The overall incidence of lower extremity lymphedema after gynecologic malignancy treatment is about 25% and can be as high as 70% in special groups . Age, weight, radiotherapy dose, duration of postoperative radiotherapy, tumor stage, daily standing time, number of lymph node dissection, and co-infection are all risk factors for the occurrence of lower extremity lymphedema.

Lymphedema is characterized by sunken edema at the beginning of the disease and progresses to include swelling, numbness, heaviness, tissue fibrosis, impaired movement, and rough epidermal keratinization, and increases the risk of inflammation of the lymphatic vessels and surrounding tissues and cellulitis. Lower extremity lymphedema is a chronic progressive disease that is difficult to cure and has a negative impact on limb function, daily life, quality of life and psychological well-being.

The treatment of lymphedema includes surgical treatment and conservative treatment. The conservative treatment methods include Complex Decongestion Therapy (CDT), external application of Chinese herbal medicine and western medicine, etc. The Complex Decongestion Therapy (CDT) is the most widely used lymphedema treatment with the best efficacy internationally in recent years. The treatment method, but requires long-term or even lifelong care , which brings huge psychological burden and economic pressure to the patient's family. Therefore, lymphedema of the lower extremities should be prevented, and preventive and therapeutic measures should be taken as early as possible to improve the quality of life of patients.

Currently, studies on lymphedema prevention have focused on interventions for breast cancer-related lymphedema , while few studies have been reported on the prevention of lymphedema associated with gynecologic malignancies. Research reported that early intervention with freehand lymphatic drainage technique could effectively prevent lower limb lymphedema, and Research showed that full range of hip exercises could prevent lower limb lymphedema after cervical cancer surgery, in addition, some studies also found that freehand lymphatic drainage combined with Kegel training could prevent vulvar stage I lymphedema after cervical cancer surgery, however, these studies have some limitations, such as small sample size and limited study content. However, these studies have limitations, such as small sample size and limited study content. Moreover, there are no empirical studies on the prevention of lower extremity lymphedema in large samples, and there is no unified standard for the prevention and management of lower extremity lymphedema. Therefore, in this study, the investigators used an evidence-based approach and clinical experience to conduct a prospective study on the prevention of lower limb lymphedema in order to reduce the incidence of lower limb lymphedema, improve patients' quality of life, and reduce their economic burden.

Research objective

1. To understand the incidence of lymphedema after gynecological tumor surgery and radiotherapy and its impact on the quality of life of patients.
2. Through preventive lymphedema treatment intervention, reduce the proportion of lymphedema, reduce the economic burden of patients, and improve their quality of life.
3. We aimed to find a more economical and effective method to treat gynecological malignant tumor lymphedema.

Main outcome measures: The incidence of lower extremity lymphedema after gynecological cancer surgery and radiotherapy, and the incidence of lower extremity lymphedema after prophylactic lymphedema treatment.

Secondary outcome measures: quality of life, incidence of lymphedema symptoms, and progression-free survival (PFS).

Study population

Inclusion criteria:

1. Gynecologic oncology patients undergoing radiotherapy after lymph node surgery who voluntarily participate in this study and sign an informed consent form.
2. 18 to 60 years old.
3. Eastern Cooperative Oncology Group（ECOG) score less than 2.
4. Expected survival time greater than 3 years.
5. Hemoglobin(Hb) greater than or equal to 70 g/L, white blood cells (WBC)greater than or equal to 3.5 × 109 /L, neutrophils(ANC)greater than or equal to 1.5 × 109 /L, platelets (PLT)greater than or equal to 80 × 109 /L.
6. serum alamine aminotransferase(ALT) and glutamic oxalacetic transaminase(AST) less than 2 times the normal value and creatinine less than 1.5 times the normal value, albumin greater than or equal to 35g/L.
7. Women of childbearing potential must have had a pregnancy test (serum or urine) within 7 days prior to enrollment and have a negative result and be willing to use an appropriate method of contraception for the duration of the trial.
8. Ability to comply with the trial protocol, as judged by the investigator.

Exclusion criteria:

1. Lymphedema and deep vein thrombosis of the lower extremities were clearly diagnosed;
2. Acute infection of any kind;
3. Patients with lower extremity edema;
4. pregnancy, menstrual period;
5. Recent major abdominal surgery (determined by the investigator);
6. Radiation colitis, cystitis, intestinal infection, small bowel or large bowel diverticulitis or diverticulitis;
7. Liver fibrosis;
8. Abdominal aortic aneurysm;
9. acute phlebitis;
10. Severe arterial obstructive disease, arterial ulcer, ABPI (ankle-brachial blood pressure index) greater than 1.3 and less than 0.5;
11. Severe peripheral neuropathy;
12. Poor control of hypertension, poor control of stroke and diabetes, and severe bronchial asthma;
13. Patients who cannot understand the experimental content and cannot cooperate and those who refuse to sign the informed consent;
14. Those with concomitant diseases or other special circumstances that seriously endanger the patient's safety or affect the patient's completion of the study.

Subject Termination Criteria

1. The investigator believes that the treatment should be terminated from the perspective of the best benefit of the patients;
2. There are intolerable adverse reactions, after confirmation by the investigator;
3. Failure to complete the treatment according to the cycle and time;
4. The patient withdraws informed consent.

Elimination criteria:

(1) Those who did not meet the standards and were mistakenly included.

Random grouping (A:B=3:1): A: intervention group; B: nonintervention group

The indication was for patients with gynecological malignancy

Early Intervention to Prevent Lower Limb Lymphedema of Gynecological Malignancy

Early Intervention to Prevent Gynecological Malignant Tumors Clinical Study of Lymphedema of the Lower Limbs in Patients With Radiotherapy After Lymphadenectomy

This study is a prospective, randomized, controlled clinical trial of a single center in China and plans to enroll 400 patients. 1.Patients with diagnosed gynecological malignancies who underwent pelvic and abdominal lymphadenectomy and required pelvic radiotherapy. 2.Random grouping (A:B=3:1).

3.Preventive lymphedema health education was given to patients with gynecological malignant tumors without contraindications before surgery. 4.All patients were evaluated for edema, lymphedema symptoms and quality of life ,Bioelectrical impedance measurement and leg diameter measurement , the Gynecologic Cancer Lymphedema Questionnaire (GCLQ) , and the EORTC Quality of Life Scale (QLQ-C30) will be used

The incidence of lower extremity lymphedema after gynecological cancer surgery and radiotherapy, and the incidence of lower extremity lymphedema after prophylactic lymphedema treatment.

The quality of life of cancer patients (QLQ-C30) was used to assess the quality of life of patients. Including the overall quality of life subscale, functional subscale, symptom subscale, and individual test items. The higher the overall quality of life subscale and the functional subscale score, the better the quality or function. The more severe the symptoms.

The Gynecologic Cancer Lymphedema Questionnaire (GCLQ) was used to evaluate the subjective feelings of patients, which was mainly used to evaluate whether the limbs had symptoms such as swelling, pain, and heaviness. The evaluation included 7 symptom groups of heaviness, edema (overall), swelling (local), infection-related symptoms, pain, numbness, and limb function, with a total of 20 items.1 mark for "yes" and 0 mark for "no" for each entry. The higher the GCLQ score, the worse the subjective perception, and a score greater than or equal to 4 is recognized as the onset of lymphedema.

2-year PFS was defined as the time from randomization to the first occurrence of disease progression or death from any cause within 2 years

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study for the Treatment of Unresectable Stage III or Metastatic Stage IV Melanoma	NCT00281541	Melanoma	YM155	18 Years -	Astellas Pharma Inc
A Study for the Treatment of Hormone Refractory Prostate Cancer (HRPC) in Patients Previously Treated With Chemotherapy	NCT00257478	Prostate Cancer Cancer of Prost... Prostatic Cance... Cancer of the P...	YM155	18 Years -	Astellas Pharma Inc
LUCY: A Study for the Treatment of Non-Small Cell Lung Cancer (NSCLC) in Patients Previously Treated With Chemotherapy	NCT00328588	Lung Cancer Cancer of Lung Cancer of the L... Non-Small Cell ... Carcinoma, Non-...	YM155	18 Years -	Astellas Pharma Inc
A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction After Radical Prostatectomy	NCT00106392	Erectile Dysfun... Prostate Cancer	Tacrolimus Placebo	- 65 Years	Astellas Pharma Inc
Early Intervention to Prevent Lower Limb Lymphedema of Gynecological Malignancy	NCT05793749	Uterine Cervica... Endometrial Neo... Lymphedema Treatment Effec...	Prophylactic ly...	18 Years - 60 Years	Chongqing University Cancer Hospital
Early Intervention to Prevent Lower Limb Lymphedema of Gynecological Malignancy	NCT05793749	Uterine Cervica... Endometrial Neo... Lymphedema Treatment Effec...	Prophylactic ly...	18 Years - 60 Years	Chongqing University Cancer Hospital
A Study for the Treatment of Unresectable Stage III or Metastatic Stage IV Melanoma	NCT00281541	Melanoma	YM155	18 Years -	Astellas Pharma Inc
A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction After Radical Prostatectomy	NCT00106392	Erectile Dysfun... Prostate Cancer	Tacrolimus Placebo	- 65 Years	Astellas Pharma Inc

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