Clinical trial · Interventional
Ramosetron, Aprepitant and Dexamethasone (RAD) in Solid Cancer
A Phase II Study to Evaluate the Efficacy and Tolerability of Ramosetron, Aprepitant and Dexamethasone (RAD) in Preventing Cisplatin-induced Nausea and Vomiting in Chemotherapy-naïve Patients With Solid Cancer
- 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)
Cisplatin is one of the most emetogenic drugs used in clinical practice and it could result in poor compliance with chemotherapy. The 5-HT3 receptor antagonists prevent vomiting in acute phase emesis after chemotherapy in 73 - 92% of cisplatin-treated patients when coadministered with steroids, but they appear to lack efficacy in the delayed phase emesis. Ramosetron, a new 5-HT3 receptor antagonists, has been shown to have equivalent efficacy and tolerability and a longer duration of effect than granisetron in preventing acute vomiting in patients undergoing cisplatin-containing chemotherapy. Acute phase emesis was prevented in 84.8% of patients receiving ramosetron plus dexamethasone, but the CR rate of total phase emesis was less than 60%. Aprepitant is a selective, high-affinity NK1 receptor antagonist. Adding aprepitant to 5-HT3 receptor antagonists and steroid improve CR rate of not only chemotherapy induced acute emesis and but also delayed emesis by 11-14 and 20 percentage points, respectively. But until now, there was no information that which 5-HT3 receptor antagonists is the best partner for aprepitant. Therefore, we initiated a prospective, open-label, phase II study to assess the efficacy and tolerability of a combination of ramosetron, aprepitant and dexamethasone (RAD) in the prevention of cisplatin based CINV in chemotherapy-naïve patients with solid cancer
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 |
|---|---|---|---|
| Postoperative Nausea and Vomiting | — | UNRESOLVED | — |
| Solid Tumour | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ramosetron, Aprepitant, Dexamethasone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ramosetron, Aprepitant, Dexamethasone
- interventionNames
- Drug: Ramosetron, Aprepitant, Dexamethasone
Primary outcomes (1)
- measure
- Complete response (CR) rate of RAD for the prevention of chemotherapy induced nausea vomiting (CINV) during overall phase (form 1 to 5 days) (overall phase is defined as acute and delayed phase)
- timeFrame
- from chemotherapy day 1 to day 5
Secondary outcomes (4)
- measure
- CR rate of RAD for the prevention of acute and delayed phase of CINV (from 0 to 24 hours /from 2 to 5 days)
- timeFrame
- until 1 month after chemotherapy
- measure
- Severity of nausea
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 18 -75 years, both sex * ECOG performance status 0-2 * Histologically proven solid cancer, chemotherapy-naïve patient * Planed to receive cisplatin (≥ 50mg/m2) based, single day chemotherapy, * No nausea or vomiting within 72 hours prior to chemotherapy * Serum Cr \< 2.5 mg/dl, or calculated CCr ≥ 50 ml/min * Serum total bilirubin \< 2 mg/dl, AST/ALT \< 3 times the upper normal limit , ALP \< 5 times the upper normal limit * Absolute neutrophil count ≥ 1,500/μL, platelet ≥ 100,000/μL * Expected life duration ≥ 3 months * 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 active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, active gastric or duodenal ulcers, or pregnancy or breast-feeding * Patients who should take steroid, antiemetics, pimozide, terfenadine, astemizole, cisapride, rifampin, carbamazepine, phenytoin, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir or nelfinavir for the treatment of other diseases * Patients taking any medicine, which could affect study results, within 1 week before chemotherapy (or taking anti-emetics within 48 hours before chemotherapy). Prior to beginning chemotherapy, single-agent benzodiazepines as hypnotic is allowed, but it can't be receiving during day 1-6 of 1st chemotherapy cycle. * Patients with symptomatic brain metastasis * Patients with GI obstruction or other diseases that could provoke nausea and vomiting * Patients receiving RT on brain, abdomen or pelvis within 2 weeks before chemotherapy * Patients who cannot understand informed consent or express his/her condition * Patients who cannot swallow drugs * Patients who have known allergy or severe side effect on study drugs
References
Publications (0)
Data not yet available