Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Randomized Pilot Study of Palonosetron Hydrochloride in Preventing Radiotherapy-Induced Nausea and Vomiting in Patients With Primary Gastrointestinal and/or Retroperitoneal Sarcomas

Basic Trial Information

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Scheduled to undergo at least 3 weeks of external-beam radiation therapy to the abdomen
• No brain metastases
• No previous palonosetron hydrochloride
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed) to one of four treatment groups.

Patients in group one will receive an infusion of palonosetron hydrochloride on day 1.

Patients in group two will receive an infusion of palonosetron hydrochloride on days 1 and 4.

Patients in group three will receive an infusion of a placebo on day 1.

Patients in group four will receive an infusion of a placebo on days 1 and 4.

In all groups, courses may repeat each week during radiation therapy.

Patients will fill out nausea and vomiting questionnaires at the beginning of the study and once a day during radiation therapy. They will also keep symptom diaries each week during radiation therapy.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Michele Yvette Halyard, MD, Protocol chair		Ph: 480-301-8120 Email: mhalyard@mayo.edu

Registry Information
Official Title		A Pilot Phase II, Randomized, Double Blind Trial of Palonosetron versus Placebo to Prevent Radiation Therapy Induced Nausea and Vomiting
Trial Start Date		2009-09-30
Trial Completion Date		2011-08-07 (estimated)
Registered in ClinicalTrials.gov		NCT00903396
Date Submitted to PDQ		2009-05-04
Information Last Verified		2011-03-04

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