Clinical trial · Interventional
Study of Aprepitant / Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting (CINV) in Colorectal Cancer Patients - SENRI Trial
Multicenter Randomized Controlled Trial of Combination Antiemetic Therapy With Aprepitant / Fosaprepitant in Patients With Colorectal Cancer Receiving Oxaliplatin-based Chemotherapy
NCT01344304CI-TRIAL-00050355completedN/AClinicalTrials.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 object of this study is to evaluate the superiority of aprepitant therapy with a 5HT3-receptor antagonist, dexamethasone and aprepitant compared to standard therapy with a 5HT3-receptor antagonist and dexamethasone for prevention of nausea and vomiting in first course chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aprepitant / Fosaprepitant | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard therapy
- description
- The patients are treated with 5HT3-receptor antagonist + dexamethasone during the first course, then treated with aprepitant / fosaprepitant + 5HT3-receptor antagonist + dexamethasone
- type
- EXPERIMENTAL
- label
- Aprepitant / Fosaprepitant therapy
- description
- The patients are treated with aprepitant / fosaprepitant + 5HT3-receptor antagonist + dexamethasone during first and second courses.
- interventionNames
- Drug: Aprepitant / Fosaprepitant
Primary outcomes (1)
- measure
- Patient diary recording nausea, emesis, food ingestion, and rescue therapy
- timeFrame
- From initiating administration of anticancer agents to day 6 (120 hours)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Age: ≥20 years old * Sex: Not specified * Patients with colon/rectal cancer who first underwent FOLFOX, XELOX or SOX regimen including oxaliplatin at ≥85 mg/m2 (naive patient), or those who had already started chemotherapy and had nausea of Grade 2 or higher in the last course or an earlier course (non-naive patient). * Stage: not specified (neoadjuvant/adjuvant chemotherapy, advanced or recurrent type are allowed) * Combination of molecular targeted therapy: allowable * Written informed consent for participation in the study. Exclusion Criteria: * Severe liver or kidney disease * Nausea/vomiting within 24 hr prior to chemotherapy. * Treatment with antiemetics within 24 hr prior to chemotherapy. * Presence of factors causing nausea/vomiting other than chemotherapy (e.g. brain tumor, gastrointestinal obstruction, active peptic ulcer disease, brain metastasis) * Presence of a disease precluding 3-day administration of dexamethasone (e.g. uncontrollable diabetes) * Pregnant or lactating women, women who plan to become pregnant. * Current treatment with pimozide. * Any patient judged to be inappropriate for the study by the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.