Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Adenocarcinoma

Prostatic Neoplasms

Neoplasm Metastasis

Lymphatic Metastasis

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplastic Processes

All Drugs and Chemicals

Antineoplastic Agents

Micronutrients

Vitamins

Androgens

Hormones

Axitinib

Androgen Antagonists

Ascorbic Acid

Methyltestosterone

Testosterone

Testosterone undecanoate

Testosterone enanthate

Testosterone 17 beta-cypionate

Estrogens, Conjugated (USP)

Estrogens

Hormone Antagonists

Antioxidants

Protective Agents

Trace Elements

Antineoplastic Agents, Hormonal

Anabolic Androgenic Steroids

Anabolic Agents

Protein Kinase Inhibitors

Enzyme Inhibitors

Vitamin C

Patients receive antiandrogen therapy per standard care and axitinib PO BID for 4 months. Patients then undergo radical prostatectomy and pelvic lymph node dissection.

Patients receive antiandrogen therapy per standard care for 4 months and then undergo radical prostatectomy and pelvic lymph node dissection.

Antiandrogen Therapy

Radical Prostatectomy

Regional Lymph Node Dissection

Amado J Zurita Saavedra

This randomized phase IIA trial studies how well antiandrogen therapy works with or without axitinib before surgery in treating patients with previously untreated prostate cancer that is known or suspected to have spread to lymph nodes. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as antiandrogen therapy may lessen the amount of androgen made by the body. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if antiandrogen therapy is more effective with or without axitinib before surgery in treating patients with prostate cancer.

PRIMARY OBJECTIVES:

I. To compare the proportion of patients progression-free one year after treatment with axitinib plus androgen deprivation versus (vs.) androgen deprivation therapy alone and surgery in newly diagnosed prostate cancer patients with lymph node metastases (TxN1M0 or TxNxM1a) or clinical suspicion of lymph node metastases.

SECONDARY OBJECTIVES:

I. To compare the rate of pathologic complete response (pCR) in the primary tumor.

II. To evaluate time to progression. III. Describe the perioperative and postoperative morbidity of pre-surgical treatment.

IV. Evaluate the effects of a 6-month time course of androgen deprivation with or without axitinib in prostate cancer tissue and blood.

V. Develop a prospective tissue archive of prostate tumors that have metastasized to lymph nodes.

OUTLINE:

Patients receive antiandrogen therapy per standard care for 8 weeks.

Patients are then randomized to 1 of 2 treatment arms.

ARM I: Patients receive antiandrogen therapy per standard care and axitinib orally (PO) twice daily (BID) for 4 months. Patients then undergo radical prostatectomy and pelvic lymph node dissection.

ARM II: Patients receive antiandrogen therapy per standard care for 4 months and then undergo radical prostatectomy and pelvic lymph node dissection.

After completion of study treatment, patients are followed up at 1 and 3 months, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then yearly thereafter.

Antiandrogen Therapy With or Without Axitinib Before Surgery in Treating Patients With Previously Untreated Prostate Cancer With Known or Suspected Lymph Node Metastasis

Pre-Surgical Androgen Deprivation Therapy With or Without Axitinib in Previously Untreated Prostate Cancer Patients With Known or Suspected Lymph Node Metastasis

Time to Prostate-specific antigen (PSA)-progression measured from the date of radical prostatectomy to the occurrence of a serum PSA \>1.0 ng/mL (confirmed by a second measurement at least 2 weeks apart). PSA-monitoring every 3 months after surgery for the first 12 months, every 4 months in the second year, every 6 months in the third to fifth year, and yearly thereafter until PSA or radiologic progression.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Digestive System Diseases

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Herbal and Botanical

Cola

RNA marker analysis of lymph node and primary tumors

microarray profiling of primary tumors

reverse transcriptase-polymerase chain reaction of lymph node specimens

diagnostic laboratory RNA and DNA biomarker analysis of primary tumors

regional lymph node dissection

lymph node staining for H&E and pancytokeratin IHC

Anton J. Bilchik, MD, PhD, FACS

RATIONALE: Diagnostic procedures that look for micrometastases in lymph nodes removed during surgery for colon cancer may help doctors learn the extent of disease.

PURPOSE: This phase I trial is studying lymph nodes in patients with stage II colon cancer.

OBJECTIVES:

* Determine whether the immunohistochemical and molecular presence of micrometastases in ≥ 12 lymph nodes removed during en-bloc resection in patients with stage II colon cancer correlates with 3-year disease-free survival.
* Evaluate the prognostic significance of molecular markers detected in the primary tumor and develop a microarray-based gene signature for stage II colon cancer.

OUTLINE: This is a multicenter study.

Tumor tissue and regional lymph node samples are collected during surgery for analysis of micrometastases and molecular markers by immunohistochemistry, qRT-PCR, MM qRT-PCR, qRDNA-PCR, and microarray profiling.

Patients are followed up periodically for 4 years after surgery.

Paraffin-embedded primary tumor and lymph node sections

Studying Lymph Nodes in Patients With Stage II Colon Cancer

Ultrastaging of Early Colon Cancer

The event to be used for DFS is time to recurrence (local or distant) after resection of colon cancer

The event to be used for DFS is time to death after resection of colon cancer

Saint John's Cancer Institute

Blood and Lymph Conditions

Lymphocele

Cysts

Lymphatic Diseases

Patients undergo standard robotic assisted laparoscopic prostatectomy with pelvic lymph node dissection. After lymph node dissection, patients undergo microsphere-mediated lymphocele prevention to the lymph node basin on one side of the pelvis.

Undergo standard robotic assisted laparoscopic prostatectomy

robot-assisted laparoscopic surgery

Undergo microsphere-mediated lymphocele prevention

microsphere-mediated lymphocele prevention

Ronney Abaza, MD

This study is being performed to investigate if the application of Arista absorbable hemostat (AH)®, a product approved to stop surgical bleeding, can prevent lymphoceles. Lymphoceles are collections of lymphatic fluid which can occur after a lymph node dissection for cancer. These fluid collections can become symptomatic in some patients. Arista would be applied to one side of the pelvis after a pelvic lymph node dissection, to see if this decreases the number of postoperative lymph fluid collections seen on a computed tomography (CT) scan after surgery

PRIMARY OBJECTIVES:

I. To determine whether, if applied to the lymph node basins after pelvic lymph node dissection, Arista could potentially reduce the formation of lymphoceles and consequently the need for secondary interventions.

OUTLINE:

Patients undergo standard robotic assisted laparoscopic prostatectomy with pelvic lymph node dissection. After lymph node dissection, patients undergo microsphere-mediated lymphocele prevention to the lymph node basin on one side of the pelvis.

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

Microspheres in Preventing Lymphatic Fluid Collection After Surgery in Patients With Prostate Cancer

A Pilot Clinical Trial for the Prevention of Postoperative Lymphoceles Using Absorbable Micorporous Polysaccharide Hemosphere Particles During Robotic Assisted Prostatectomy With Lymph Node Dissection

The rate of lymphoceles on each side of the pelvis will be compared. Summary statistics will be reported (mean, standard deviation, and range for the continuous variables and frequency and percentages for the categorical variables). In addition, we will determine interrelationships among specific variables using regression and correlation analyses.

Ohio State University Comprehensive Cancer Center

Rare Diseases

Carcinoma, Squamous Cell

Vulvar Neoplasms

Genital Neoplasms, Female

Vulvar Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Vulvar Cancer

radiation therapy

George C. Lewis, MD

RATIONALE: Patient abstract not available

PURPOSE: Patient abstract not available

OBJECTIVES: I. Compare the efficacy of pelvic node resection vs. bilateral groin and pelvic node irradiation for invasive squamous cell carcinoma of the vulva in patients having positive groin nodes.

OUTLINE: Randomized study. Arm I: Surgery. Deep pelvic node dissection on sides containing positive nodes only. Arm II: Radiotherapy. Megavoltage (1 MeV or greater) to bilateral groin and pelvic nodes.

PROJECTED ACCRUAL: Anticipated annual accrual is approximately 200 patients, with an active phase estimated at 2.5-3 years. Protocol closed July 1984.

Radiation Therapy or Surgery in Treating Patients With Previously Untreated Vulva Cancer With Positive Groin Lymph Nodes

Phase III Radiation Therapy vs Pelvic Node Resection for Previously Untreated Invasive Squamous Cell Carcinoma of the Vulva With Positive Groin Nodes

Gynecologic Oncology Group

Philip J. DiSaia

Mouth and Tooth Diseases

Head and Neck Neoplasms

Mouth Neoplasms

Oral Squamous Cell Carcinoma

Oral Cancer

Lip and Oral Cavity Cancer

Tongue Cancer

questionnaire administration

psychosocial assessment and care

quality-of-life assessment

therapeutic conventional surgery

Iain Hutchison

RATIONALE: Surgery may be an effective treatment for oral cancer. It is not yet known whether surgery to remove the tumor and lymph nodes in the neck is more effective than surgery to remove the tumor alone in treating patients with early-stage oral cancer.

PURPOSE: This randomized clinical trial is comparing two types of neck surgery to see how well they work in treating patients with early stage oral cancer.

OBJECTIVES:

* To determine whether the use of a selective neck dissection (SEND) used electively on all patients presenting with stage I-II oral cavity squamous cell carcinoma (SCC) improves survival, disease-free survival, and loco-regional disease control rates.
* To determine how SEND and complex reconstruction affect quality of life and mental health.
* To determine whether the use of SEND on all patients presenting with stage I-II oral cavity SCC represents a cost-effective use of resources.

OUTLINE: This is a multicenter study. Patients are stratified by age (\< 40 vs 40-64 vs ≥ 65 years of age), tumor stage (T1 vs T2), and surgeon.

* Arm I: Patients undergo resection of the primary tumor with neck dissection.
* Arm II: Patients undergo resection of the primary tumor alone. Patients complete the EORTC QLQ-C30, EORTC QLQ - H\&N35, and the Hospital Anxiety and Depression Scale (HADS) before surgery and at 6, 12, and 24 months after surgery. Patients also complete the EQ-5D questionnaire at baseline, 6 months, 12 months, and 24 months. Additionally, a self-completion Health Service Use questionnaire is completed every 2 months, during the first 24 months after treatment, to enable costs to the NHS to be monitored.

After surgery, patients are followed periodically for up to 5 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Neck Surgery in Treating Patients With Early-Stage Oral Cancer

SEND Trial The Role of Selective Neck Dissection Used Electively in Patients With Early Oral Squamous Cell Carcinoma (1-3cm Primary Size) and No Clinical Evidence of Lymph Node Metastases in the Neck

The Facial Surgery Research Foundation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Antiandrogen Therapy With or Without Axitinib Before Surgery in Treating Patients With Previously Untreated Prostate Cancer With Known or Suspected Lymph Node Metastasis	NCT01409200	Metastatic Mali... Prostate Ductal... Stage III Prost... Stage IV Prosta...	Antiandrogen Th... Axitinib Radical Prostat... Regional Lymph ...	18 Years -	M.D. Anderson Cancer Center
Studying Lymph Nodes in Patients With Stage II Colon Cancer	NCT00949312	Colorectal Canc...	RNA marker anal... microarray prof... reverse transcr... diagnostic labo... regional lymph ... lymph node stai...	18 Years - 85 Years	Saint John's Cancer Institute
Microspheres in Preventing Lymphatic Fluid Collection After Surgery in Patients With Prostate Cancer	NCT01644136	Lymphocele Prostate Cancer	robot-assisted ... regional lymph ... microsphere-med...	-	Ohio State University Comprehensive Cancer Center
Radiation Therapy or Surgery in Treating Patients With Previously Untreated Vulva Cancer With Positive Groin Lymph Nodes	NCT00898352	Vulvar Cancer	regional lymph ... radiation thera...	-	GOG Foundation
Neck Surgery in Treating Patients With Early-Stage Oral Cancer	NCT00571883	Head and Neck C...	questionnaire a... psychosocial as... quality-of-life... regional lymph ... therapeutic con...	16 Years - 120 Years	National Cancer Institute (NCI)
Microspheres in Preventing Lymphatic Fluid Collection After Surgery in Patients With Prostate Cancer	NCT01644136	Lymphocele Prostate Cancer	robot-assisted ... regional lymph ... microsphere-med...	-	Ohio State University Comprehensive Cancer Center

Spots Global Cancer Trial Database for regional lymph node dissection