Clinical trial · Interventional
Ramosetron, Aprepitant, and Dexamethasone Versus Palonosetron, Aprepitant, and Dexamethasone
Comparison of Ramosetron, Aprepitant, and Dexamethasone (RAD) With Palonosetron, Aprepitant, and Dexamethasone (PAD) for Prevention of Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy
NCT02532634CI-TRIAL-00032870RAPAcompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to compare the anti-emetic effect of ramosetron plus aprepitant and dexamethasone with palonosetron plus aprepitant and dexamethasone in patients receiving highly emetogenic chemotherapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Tumors | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| palonosetron, aprepitant, dexamethasone | Drug | — | UNRESOLVED |
| ramosetron, aprepitant, dexamethasone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ramosetron, aprepitant, dexamethasone
- description
- 1. Ramosetron 0.3mg IV day1 2. Aprepitant 125mg PO qd day1, 80mg po qd day 2, 3 3. Dexamethasone 12mg IV or PO qd day1, 8mg PO day 2, 3, 4
- interventionNames
- Drug: ramosetron, aprepitant, dexamethasone
- type
- ACTIVE_COMPARATOR
- label
- palonosetron, aprepitant, dexamethasone
- description
- 1. Palonosetron 0.25mg IV day1 2. Aprepitant 125mg PO qd day1, 80mg po qd day 2, 3 3. Dexamethasone 12mg IV or PO qd day1, 8mg PO day 2, 3, 4
- interventionNames
- Drug: palonosetron, aprepitant, dexamethasone
Primary outcomes (1)
- measure
- To compare the overall complete response (CR) of RAD to PAD (Overall CR defined as no emesis, no rescue medication, at cycle 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * The patient's age is ≥ 19 years old * Histologically or cytologically confirmed solid tumor * Patients diagnosed as malignancy who will be treated with highly emetogenic chemotherapeutic agents (NCCN guideline v2.0, 2014 anti-emesis). (Cisplatin dosage is over 50mg/m2, combination therapy is available with other chemotherapeutic agents and including lymphoma) * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Available oral administration of study drugs * Adequate organ functions as follows: 1) Hematologic - white blood cell count (WBC) ≥ 3000 microliter (microL) or Neutrophil≥ 1500 micro/L, Platelet ≥ 100,000/microL; 2) Serum Creatinine ≤ 1.5 times upper limit of normal; 3) Hepatic function - Total bilirubin, AST, ALT ≤2.5 times upper limit of normal, ALP ≤ 2 times upper limit of normal( except ALP increasing due to bone metastasis * Patients with normal range of serum K, Mg and hold serum Ca over lower limit of normal range * Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital Exclusion Criteria: * Patients with severe Hypertension, severe Heart disease, congenital long QT syndrome, bradyarrhythmia severe kidney disease(serum creatinine≥3㎎/㎗), liver disease (AST, ALT ≥ 2.5 times of upper normal range, ALP ≥ 2 times of upper normal range) * Patients with GI obstruction, active gastric ulcer or other diseases that could provoke nausea and vomiting * Patients who have nausea and vomiting within 1 week before chemotherapy * Patients who should take steroid, antiemetics, antipsychotic agent including benzodiazepine, pimozide, terfenadine, astemizole, cisapride, rifampin, carbamazepine, phenytoin, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir or nelfinavir, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors for the treatment of other diseases * Patients with brain tumor, brain metastasis or seizure * Patients receiving chemotherapy within 6 months before enrollment * Patients who need radiation therapy during study period or receiving radiation therapy within 2 weeks before chemotherapy * Patients who have known allergy or severe side effect on study drugs(5-HT3 antagonist and aprepitant) * Pregnant or lactating women, or women who wish to become pregnant * Patients with drug abuse, a mental disease and difficult to communicate with investigators * Others whom the investigator judges inappropriate as subjects for this study
References
Publications (0)
Data not yet available
No reference posted for this study.