Clinical trial · Observational
Comparison of Concomitant Cisplatin Versus Carboplatin and 5-fluorouracil With Radiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma
- 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)
Concomitant chemoradiotherapy improves overall survival in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) compared to radiotherapy alone. Cisplatin 100 mg/m2 at day 1, 22 and 43 is widely used but results in considerable acute and late toxicity. Three cycles of carboplatin plus 5-fluorouracil (5-FU) is an accepted alternative but both chemotherapy regimens have not been compared prospectively. The aim of this study is to compare tolerability, efficacy, toxicity and quality of life in patients with LA-HNSCC treated with concomitant cisplatin and carboplatin plus 5-FU.
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 |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| carboplatin | Drug | Carboplatin | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Concomitant cisplatin
- description
- Patients treated with concomitant cisplatin
- interventionNames
- Drug: cisplatin
- label
- Carboplatin plus 5-FU
- description
- Patients treated with carboplatin plus 5-FU
- interventionNames
- Drug: carboplatin
- Drug: 5-FU
Primary outcomes (1)
- measure
- Chemotherapy completion rate
- timeFrame
- 1 year
- description
- The percentage of patients who completed 3 cycles of chemotherapy between both cohorts will be compared.
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Stage III-IV LA-HNSCC of hypopharynx, oropharynx, larynx, oral cavity * Primary treatment with concomitant chemoradiotherapy consisting of three-weekly cisplatin or carboplatin plus 5-FU * Age ≤ 70 years * No previous treatment for head and neck cancer * No distant metastases Exclusion Criteria: * Previous treatment for head and neck cancer * Distant metastases
References
Publications (0)
Data not yet available