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Spots Global Cancer Trial Database for Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer

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Trial Identification

Brief Title: Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer

Official Title: A Pilot Phase II, Randomized, Double Blind Trial of Palonosetron Versus Placebo to Prevent Radiation Therapy Induced Nausea and Vomiting

Study ID: NCT00903396

Study Description

Brief Summary: RATIONALE: Palonosetron hydrochloride may prevent nausea and vomiting caused by radiation therapy. It is not yet known whether palonosetron hydrochloride is more effective than a placebo in preventing nausea and vomiting. PURPOSE: This randomized phase II trial is studying the side effects of palonosetron hydrochloride and to see how well it works in preventing nausea and vomiting caused by radiation therapy in patients with primary abdominal cancer.

Detailed Description: OBJECTIVES: * Evaluate the rate of complete responses, defined as no vomiting and no nausea, in patients with primary gastrointestinal and/or retroperitoneal sarcomas treated with two different dosing schedules of palonosetron hydrochloride during abdominal radiotherapy as part of their cancer treatment. * Determine the tolerability of palonosetron hydrochloride vs placebo in these patients. * Validate patient diaries for assessing nausea and vomiting by comparing with alternative methods for measuring nausea and vomiting in order to determine the optimal approach for future studies. OUTLINE: Patients are stratified according to planned radiotherapy duration (\< 5 weeks vs ≥ 5 weeks), planned concurrent fluorouracil ( yes vs no), and gender. Patients are randomized to 1 of 4 treatment arms. * Arm I: Patients receive palonosetron hydrochloride IV on day 1. * Arm II: Patients receive palonosetron hydrochloride IV on days 1 and 4. * Arm III: Patients receive placebo IV on day 1. * Arm IV: Patients receive placebo IV on days 1 and 4. In all arms, courses repeat weekly during radiotherapy in the absence of disease progression or unacceptable toxicity. Patients complete nausea and vomiting questionnaires and diaries at baseline and daily during radiotherapy. Patients also complete symptom experience diaries weekly during radiotherapy.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Mayo Clinic Scottsdale, Scottsdale, Arizona, United States

Mayo Clinic - Jacksonville, Jacksonville, Florida, United States

Trinity Cancer Center at Trinity Medical Center - 7th Street Campus, Moline, Illinois, United States

, Moline, Illinois, United States

Elkhart Clinic, LLC, Elkhart, Indiana, United States

Michiana Hematology-Oncology, PC - Elkhart, Elkhart, Indiana, United States

Elkhart General Hospital, Elkhart, Indiana, United States

Howard Community Hospital, Kokomo, Indiana, United States

Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana, United States

Michiana Hematology-Oncology, PC - South Bend, Mishawaka, Indiana, United States

Saint Joseph Regional Medical Center, Mishawaka, Indiana, United States

Michiana Hematology Oncology PC - Plymouth, Plymouth, Indiana, United States

CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States

Memorial Hospital of South Bend, South Bend, Indiana, United States

South Bend Clinic, South Bend, Indiana, United States

Michiana Hematology Oncology PC - La Porte, Westville, Indiana, United States

, Bettendorf, Iowa, United States

Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa, United States

Mercy Medical Center - Sioux City, Sioux City, Iowa, United States

St. Luke's Regional Medical Center, Sioux City, Iowa, United States

Wesley Medical Center, Wichita, Kansas, United States

Michiana Hematology Oncology PC - Niles, Niles, Michigan, United States

Lakeland Regional Cancer Care Center - St. Joseph, Saint Joseph, Michigan, United States

Lakeside Cancer Specialists, PLLC, Saint Joseph, Michigan, United States

Duluth Clinic Cancer Center - Duluth, Duluth, Minnesota, United States

CCOP - Duluth, Duluth, Minnesota, United States

Miller - Dwan Medical Center, Duluth, Minnesota, United States

Fergus Falls Medical Group, PA, Fergus Falls, Minnesota, United States

Mayo Clinic Cancer Center, Rochester, Minnesota, United States

CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States

St. John's Regional Health Center, Springfield, Missouri, United States

Hulston Cancer Center at Cox Medical Center South, Springfield, Missouri, United States

CCOP - Montana Cancer Consortium, Billings, Montana, United States

St. Vincent Healthcare Cancer Care Services, Billings, Montana, United States

Hematology-Oncology Centers of the Northern Rockies - Billings, Billings, Montana, United States

Billings Clinic - Downtown, Billings, Montana, United States

Bozeman Deaconess Cancer Center, Bozeman, Montana, United States

St. James Healthcare Cancer Care, Butte, Montana, United States

Big Sky Oncology, Great Falls, Montana, United States

Great Falls Clinic - Main Facility, Great Falls, Montana, United States

Sletten Cancer Institute at Benefis Healthcare, Great Falls, Montana, United States

Northern Montana Hospital, Havre, Montana, United States

St. Peter's Hospital, Helena, Montana, United States

Glacier Oncology, PLLC, Kalispell, Montana, United States

Kalispell Medical Oncology at KRMC, Kalispell, Montana, United States

Kalispell Regional Medical Center, Kalispell, Montana, United States

Montana Cancer Specialists at Montana Cancer Center, Missoula, Montana, United States

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana, United States

CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States

Creighton University Medical Center, Omaha, Nebraska, United States

Bismarck Cancer Center, Bismarck, North Dakota, United States

Medcenter One Hospital Cancer Care Center, Bismarck, North Dakota, United States

Mid Dakota Clinic, PC, Bismarck, North Dakota, United States

St. Alexius Medical Center Cancer Center, Bismarck, North Dakota, United States

Altru Cancer Center at Altru Hospital, Grand Forks, North Dakota, United States

Geisinger Cancer Institute at Geisinger Health, Danville, Pennsylvania, United States

Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre, Pennsylvania, United States

Rapid City Regional Hospital, Rapid City, South Dakota, United States

Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States

Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay, Wisconsin, United States

St. Mary's Hospital Medical Center - Green Bay, Green Bay, Wisconsin, United States

St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States

Franciscan Skemp Healthcare - La Crosse Campus, La Crosse, Wisconsin, United States

Holy Family Memorial Medical Center Cancer Care Center, Manitowoc, Wisconsin, United States

Bay Area Cancer Care Center at Bay Area Medical Center, Marinette, Wisconsin, United States

Door County Cancer Center at Door County Memorial Hospital, Sturgeon Bay, Wisconsin, United States

Green Bay Oncology, Limited - Sturgeon Bay, Sturgeon Bay, Wisconsin, United States

Rocky Mountain Oncology, Casper, Wyoming, United States

Welch Cancer Center at Sheridan Memorial Hospital, Sheridan, Wyoming, United States

Contact Details

Name: Michele Yvette Halyard, MD

Affiliation: Mayo Clinic

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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