Clinical trial · Interventional
Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer
A Pilot Phase II, Randomized, Double Blind Trial of Palonosetron Versus Placebo to Prevent Radiation Therapy Induced Nausea and Vomiting
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
| Carcinoma of the Appendix | Appendix Carcinoma | ALIAS | 0.90 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Extrahepatic Bile Duct Cancer | Malignant Extrahepatic Bile Duct Neoplasm | ALIAS | 0.90 |
| Gallbladder Cancer | Malignant Gallbladder Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastrointestinal Carcinoid Tumor | Digestive System Neuroendocrine Tumor G1 | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| palonosetron hydrochloride | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive palonosetron hydrochloride IV on day 1.
- interventionNames
- Drug: palonosetron hydrochloride
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive palonosetron hydrochloride IV on days 1 and 4.
- interventionNames
- Drug: palonosetron hydrochloride
- type
- PLACEBO_COMPARATOR
- label
- Arm III
- description
- Patients receive placebo IV on day 1.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available