Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Adenocarcinoma

Urinary Bladder Neoplasms

Carcinoma, Transitional Cell

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Transitional Cell Carcinoma

questionnaire administration

quality-of-life assessment

robot-assisted laparoscopic surgery

therapeutic conventional surgery

therapeutic laparoscopic surgery

Contact Person

John Kelly, MD

RATIONALE: Minimal-access surgery uses a smaller opening in the body to remove the tumor than is used in standard surgery. It is not yet known whether minimal-access surgery to remove the bladder is more effective than standard surgery to remove the bladder in treating patients with bladder cancer.

PURPOSE: This randomized phase II trial is studying standard surgery to see how well it works compared with minimal-access surgery in treating patients with bladder cancer.

OBJECTIVES:

Primary

* To determine the feasibility of randomizing patients with bladder cancer to undergo an open cystectomy versus a minimal-access cystectomy (laparoscopic or robotic cystectomy).

Secondary

* To assess the safety and efficacy of laparoscopic or robotic cystectomy and the reasons for non-acceptance of randomization.
* To collect safety and toxicity data, including measures of postoperative morbidity and surgical complications. (Exploratory)
* To investigate anatomical lymph node dissection (an indicator for oncological clearance) and completeness of cancer surgery. (Exploratory)
* To determine the quality of life of these patients using EORTC QLQ-C30 and EORTC QLQ-BLM30 questionnaires. (Exploratory)

OUTLINE: This is a multicenter study. Patients who consent to the interview-only (but not randomization) undergo a qualitative interview exploring factors relating to this decision. Patients who consent to randomization are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo an open radical cystectomy.
* Arm II: Patients undergo a minimal-access radical cystectomy (laparoscopic or robotic).

Patients complete quality-of-life questionnaires (EORTC QLQ-C30 and EORTC QLQ-BLM30) at baseline and at 4 weeks, 6 weeks, 8 weeks, 3 months, and 6 months after completion of study therapy. Blood, urine, and tissue samples are collected from some patients at baseline and during study for laboratory analysis.

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

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

PROJECTED ACCRUAL: A total of 92 patients (72 patients for the randomized portion and 20 for the interview-only portion) are accrued for this study.

Standard Surgery or Minimal-Access Surgery in Treating Patients With Bladder Cancer

Bladder Cancer: Open Versus Laparoscopic or Robotic Cystectomy. A Study to Determine the Feasibility of Randomization to Open Versus Minimal Access Cystectomy in Patients With Bladder Cancer.

Wales Cancer Trials Unit

Digestive System Diseases

Diseases and Abnormalities at or Before Birth

Symptoms and General Pathology

Wounds and Injuries

Skin and Connective Tissue Diseases

Adenomatous Polyposis Coli

Syndrome

Recurrence

Crohn Disease

Surgical Wound

Polyps

Adenomatous Polyps

Peutz-Jeghers Syndrome

Intestinal Polyposis

Colonic Neoplasms

Inflammatory Bowel Diseases

Intestinal Diseases

Gastroenteritis

Gastrointestinal Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Colonic Diseases

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

Lentigo

Melanosis

Hyperpigmentation

Pigmentation Disorders

Skin Diseases

Familial Adenomatous Polyposis

MYH-associated Polyposis

Patients undergo single incision laparoscopic surgery with GelPort® attachment.

Undergo single incision laparoscopic surgery

David Renton, MD

This study is being done to evaluate single incision laparoscopic surgery (SILS) for colorectal diseases, compared to multi-port laparoscopic surgery. This study is also intended to standardize the SILS technique for colorectal diseases

PRIMARY OBJECTIVES:

I. To report the experience of SILS procedure in the treatment of colorectal disease.

II. To standardize the SILS technique.

OUTLINE:

Patients undergo single incision laparoscopic surgery with GelPort® attachment.

After completion of study treatment, patients are followed up at 2 weeks, 3 and 6 months, and at 1 year.

Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease

Single Incision Laparoscopic Surgery (SILS) for Colorectal Disease - A Novel Approach

Summarized using descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data).

Linear mixed model will be applied with repeated measures considering the observations from the same patient are correlated.

Ohio State University Comprehensive Cancer Center

Blood and Lymph Conditions

Lymphedema

Uterine Cervical Neoplasms

Vulvar Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Lymphatic Diseases

Vulvar Diseases

Vulvar Cancer

Patients with vulvar cancer undergo a radical vulvectomy or hemi-vulvectomy followed immediately by an ipsilateral or bilateral inguinal-femoral lymphadenectomy. (Closed to accrual as of June 9, 2014)

Patients with cervical cancer undergo a radical hysterectomy or trachelectomy and bilateral pelvic lymphadenectomy +/- para-aortic nodal sampling via vaginal, laparoscopic, or open route.

Patients with endometrial cancer undergo a laparoscopic-assisted vaginal hysterectomy, a total laparoscopic hysterectomy, or total abdominal hysterectomy with pelvic lymphadenectomy +/- para-aortic node sampling.

Patients undergo limb measurements at baseline, weeks 4-6, and at 3, 6, 9, 12, 18, and 24 months.

Quality-of-Life Assessment

Questionnaire Administration

Study of High Risk Factors

Therapeutic Conventional Surgery

Therapeutic Laparoscopic Surgery

Therapeutic Lymphadenectomy

Richard Barakat

This clinical trial studies lymphedema after surgery in patients with endometrial cancer, cervical cancer, or vulvar cancer. Collecting information over time about how often lymphedema occurs in patients undergoing surgery and lymphadenectomy for endometrial cancer, cervical cancer, and vulvar cancer may help doctors learn more about the disease and plan the best treatment.

PRIMARY OBJECTIVES:

I. To prospectively estimate the incidence of lower extremity lymphedema in patients undergoing radical surgery with a concurrent lymphadenectomy with a concurrent lymphadenectomy for a gynecologic malignancy.

II. To identify risk factors for the development of lower extremity lymphedema following radical surgery among patients with any one of the three types of gynecologic malignancy studied and to develop a corresponding predictive model.

SECONDARY OBJECTIVES:

I. To identify the effect that lower extremity lymphedema has on quality of life (QOL) (as measured with Functional Assessment of Cancer Therapy - General \[FACT-G\] + disease specific subscale), psychological adjustment (as measured with Impact of Events Scale \[IES\] and Functional Assessment of Chronic Illness Therapy \[FACIT\] body image items) and physical disability (of lower extremity as measured with Lower Extremity Functional Scale \[LEFS\]) and physical function(as measured by FACT-Functional Wellbeing \[FW\] subscale, FACIT disease specific items \& patient-reported outcomes measurement information system \[PROMIS\] items) and to investigate potential protective mechanisms (FACT-Social Wellbeing \[SW\] subscale and patient characteristics).

II. To explore if patient self-reported symptoms (as measured with the lymphedema \[LE\] Symptom Measure \[Cancer Lymphedema Questionnaire (GCLQ)\]) are associated with the development of lymphedema in patients undergoing radical surgery for gynecologic malignancy.

TERTIARY OBJECTIVES:

I. To explore the effect of moderate or severe lymphedema (primary endpoint) on QOL outcomes, as measured by the FACT-General (G) questionnaire.

OUTLINE:

Patients with vulvar cancer undergo a radical vulvectomy or hemi-vulvectomy followed immediately by an ipsilateral or bilateral inguinal-femoral lymphadenectomy. (Closed to accrual as of June 9, 2014)

Patients with cervical cancer undergo a radical hysterectomy or trachelectomy and bilateral pelvic lymphadenectomy +/- para-aortic nodal sampling via vaginal, laparoscopic, or open route.

Patients with endometrial cancer undergo a laparoscopic-assisted vaginal hysterectomy, a total laparoscopic hysterectomy, or total abdominal hysterectomy with pelvic lymphadenectomy +/- para-aortic node sampling.

Patients undergo limb measurements at baseline, weeks 4-6, and at 3, 6, 9, 12, 18, and 24 months.

Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer

The LymphEdema and Gynecologic Cancer (LEG) Study: Incidence, Risk Factors, and Impact in Newly Diagnosed Patients

A competing risks analysis will be required to estimate the cumulative incidence of lymphedema. Transition probabilities in the Markov Chain will be estimated by simple proportions, ignoring covariates, to address this primary objective. Confidence intervals for the cumulative incidence of lymphedema then will be computed using the Delta Method, utilizing the fact that the transition proportions have and asymptotic multivariate normal distribution.

If risk factors are identified, a model will be developed to predict the level of risk (low, moderate, high) of lymphedema following gynecologic cancer treatment overall, and following treatment for endometrial cancer specifically. The predictive power of the models for these rates will be assessed.

Whether the patient self-reported symptoms are associated with the development of lymphedema wit be explored.

As measured by the FACT QOL scale, psychological adjustment as measured by the Impact of Events Subscale (IES), and FACIT body image items, physical disability as measured by the Lower Extremity Functional Scale -(LEFS) and PROs of physical health status/function (sexual), as measured by FACT-FW; FACIT \& PROMIS.

National Cancer Institute (NCI)

Gynecologic Oncology Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Standard Surgery or Minimal-Access Surgery in Treating Patients With Bladder Cancer	NCT01196403	Bladder Cancer	questionnaire a... quality-of-life... robot-assisted ... therapeutic con... therapeutic lap...	18 Years -	National Cancer Institute (NCI)
Single Incision Laparoscopic Surgery in Treating Patients With Colorectal Disease	NCT01656746	Adenomatous Pol... Crohn Disease Familial Adenom... Hereditary Inte... Recurrent Colon... Stage I Colon C... Stage IIA Colon... Stage IIB Colon... Stage IIC Colon... Stage IIIA Colo... Stage IIIB Colo... Stage IIIC Colo...	therapeutic lap...	18 Years - 80 Years	Ohio State University Comprehensive Cancer Center
Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer	NCT00956670	Lymphedema Stage IA Cervic... Stage IA Uterin... Stage IA Vulvar... Stage IB Cervic... Stage IB Uterin... Stage IB Vulvar... Stage II Uterin... Stage II Vulvar... Stage IIA Cervi... Stage IIIA Vulv... Stage IIIB Vulv... Stage IIIC Vulv... Stage IVB Vulva...	Quality-of-Life... Questionnaire A... Study of High R... Therapeutic Con... Therapeutic Lap... Therapeutic Lym...	18 Years -	GOG Foundation
Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer	NCT00956670	Lymphedema Stage IA Cervic... Stage IA Uterin... Stage IA Vulvar... Stage IB Cervic... Stage IB Uterin... Stage IB Vulvar... Stage II Uterin... Stage II Vulvar... Stage IIA Cervi... Stage IIIA Vulv... Stage IIIB Vulv... Stage IIIC Vulv... Stage IVB Vulva...	Quality-of-Life... Questionnaire A... Study of High R... Therapeutic Con... Therapeutic Lap... Therapeutic Lym...	18 Years -	GOG Foundation

Spots Global Cancer Trial Database for therapeutic laparoscopic surgery