Clinical trial · Interventional
Valproic Acid and Platinum-based Chemoradiation in Locally Advanced Head and Neck Squamous Cell Carcinoma
Efficacy Evaluation of the Combination of Valproic Acid and Standard Platinum-based Chemoradiation in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
NCT01695122CI-TRIAL-00021057completedPhase 2ClinicalTrials.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 evaluate if the addition of valproic acid to standard platinum-based chemoradiation as definitive treatment of locally advanced Head and Neck squamous cell carcinoma can improve treatment outcomes, such as response rate.
Conditions
Conditions (3)
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 Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Oral Cavity Cancer | Malignant Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Oropharyngeal Cancer | Malignant Oropharyngeal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Valproic Acid | Drug | Valproic Acid | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- valproic acid
- interventionNames
- Drug: Valproic Acid
Primary outcomes (1)
- measure
- Response Rate
- timeFrame
- Within 6 to 8 weeks after completion of chemoradiation
- description
- RECIST v 1.1
Secondary outcomes (5)
- measure
- Adverse reactions to study treatment
- measure
- Progression free survival
- timeFrame
- Three years
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Unresectable Oropharyngeal or oral cavity squamous cell carcinoma * Candidate for definitive chemoradiation * No previous treatment * Measurable disease according to RECIST v 1.1 * Previous neoplasia, other than Head and Neck, with more than five years without evidence of disease; basocellular carcinoma of the skin and in situ cervical dysplasia if resected * Age under 60 years * ECOG performance status 0-2 * Ability of understanding and giving informed consent * Adequate renal and hepatic function * Adequate bone marrow function * Normal serum magnesium * Absence of QTc prolongation * Life expectancy of over 12 weeks Exclusion Criteria: * Pregnancy * Distant metastasis * Hypersensibility to valproic acid or other antiepileptic drugs * Valproic acid chronic use * Severe neurologic impairment * Uncontrolled comorbidity * Hypoalbuminemia * Known history of hepatitis B, C or HIV
References
Publications (1)
- DERIVEDMak MP, Pasini FS, Diao L, Garcia FOT, Takahashi TK, Nakazato D, Martins RE, Almeida CM, Kulcsar MAV, Lamounier VA, Nunes EM, de Souza IC, Garcia MRT, Amadio AV, Siqueira SAC, Snitcovsky IML, Sichero L, Wang J, de Castro G Jr. Valproic acid combined with cisplatin-based chemoradiation in locally advanced head and neck squamous cell carcinoma patients and associated biomarkers. Ecancermedicalscience. 2020 Dec 15;14:1155. doi: 10.3332/ecancer.2020.1155. eCollection 2020. PMID 33574900