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NCT00903396 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2017-11-24

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Complete Response (no Episodes of Nausea or Vomiting)

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outcome · POSTED

Time to Treatment Failure, Defined as a Single Episode of Vomiting, Daily Nausea Score of Moderate or Greater, or Taking ≥ 3 Prochlorperazine or Haloperidol Tablets Per Day

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outcome · POSTED

Proportion of Patients Reporting Treatment Failure

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outcome · POSTED

Tolerability and Adverse Events as Assessed by NCI CTC v 3.0

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outcome · POSTED

Average Level of Nausea Reported and the Proportion of Patients Experiencing a Complete Response Independent of Treatment Arm

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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 days since prior chemotherapy other than fluorouracil or capecitabine used as a radiosensitizer * More than 7 days since of prior cetuximab * More than 7 days since prior and no concurrent oral steroids * No prior palonosetron hydrochloride
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive palonosetron hydrochloride IV on day 1.
    intervention Names
    1. Drug: palonosetron hydrochloride
    label
    Arm I
    type
    EXPERIMENTAL
  2. description
    Patients receive palonosetron hydrochloride IV on days 1 and 4.
    intervention Names
    1. Drug: palonosetron hydrochloride
    label
    Arm II
    type
    EXPERIMENTAL
  3. description
    Patients receive placebo IV on day 1.
    intervention Names
    1. Other: placebo
    label
    Arm III
    type
    PLACEBO_COMPARATOR
  4. description
    Patients receive placebo IV on days 1 and 4.
    intervention Names
    1. Other: placebo
    label
    Arm IV
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. Arm I
    2. Arm II
    description
    Given IV
    name
    palonosetron hydrochloride
    type
    DRUG
  2. arm Group Labels
    1. Arm III
    2. Arm IV
    description
    Given IV
    name
    placebo
    type
    OTHER
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
DOUBLE
who Masked
  1. PARTICIPANT
  2. INVESTIGATOR
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
7
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Complete Response (no Episodes of Nausea or Vomiting)
    time Frame
    Up to 2 years
secondary Outcomes
  1. measure
    Time to Treatment Failure, Defined as a Single Episode of Vomiting, Daily Nausea Score of Moderate or Greater, or Taking ≥ 3 Prochlorperazine or Haloperidol Tablets Per Day
    time Frame
    Up to 2 years
  2. measure
    Proportion of Patients Reporting Treatment Failure
    time Frame
    Up to 2 years
  3. measure
    Tolerability and Adverse Events as Assessed by NCI CTC v 3.0
    time Frame
    Up to 2 years
  4. measure
    Average Level of Nausea Reported and the Proportion of Patients Experiencing a Complete Response Independent of Treatment Arm
    time Frame
    Up to 2 years
Full 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.
Source references
Source notices and limitations
    Discovery and provenance
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      edge id
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      requested nct id
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      payload
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      true
      id
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      nct id
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      occurrences
      1. context exact
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        exact text
        NCT00903396
        start
        0
      offset unit
      unicode_code_points
      query cond
      Small Intestine Cancer
      query disease state id
      ds-small-intestine-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-small-intestine-cancer-000.json
      source file sha256
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      source json pointer
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      source kind
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      source record id
      Source null
      source string basis
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      source string sha256
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    Preserved source evidence · Not medical advice