TerminatedPhase 2

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

Stopped: Slow accrual

United States7 participantsStarted 2009-09

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

DISEASE CHARACTERISTICS: * Diagnosis of primary gastrointestinal and/or retroperitoneal sarcoma * Scheduled to undergo ≥ 3000 cGy or ≥ 3 weeks of external beam radiation to the abdomen * Radiotherapy fields to extend between T11 and L3, and of a size ≥ 100 cm\^2 * No brain metastases PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Negative pregnancy test * Not pregnant or nursing * Fertile patients must use effective contraception * Able to complete questionnaire(s) alone or with assistance * Willing to return to NCCTG enrolling institution for follow-up * Able to reliably take oral medication (for purposes of rescue medication) * No hypersensitivity to palonosetron hydrochloride or other selective 5-HT3 receptor antagonists * No comorbid systemic illness or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for study entry or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens * No nausea ≤ 48 hours prior to study enrollment * No history of dystonic reactions to prochlorperazine or haloperidol or related agents PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 7 days since prior agents known to have significant effects on emesis, including the following: * Ondansetron * Sedating antihistamines * Antipsychotics * Cannabinoids * Corticosteroids * Metoclopramide * Narcotic analgesics * Benzodiazepines * More than 7 day…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Complete Response (no Episodes of Nausea or Vomiting)

Timeframe: Up to 2 years

Trial details

NCT IDNCT00903396

SponsorAlliance for Clinical Trials in Oncology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-01

Results submitted2016-12-07

View on ClinicalTrials.gov More Anal Cancer trials