NCT01695122

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2 head-and-neck-cancer

Timeline
Completed

Started Sep 2012

Shorter than P25 for phase_2 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

2.2 years

First QC Date

September 25, 2012

Last Update Submit

February 22, 2016

Conditions

Head and Neck CancerOral Cavity CancerOropharyngeal Cancer

Keywords

Head and Neck CancerOropharyngeal cancerOral cavity cancerChemoradiationvalproic acidhistone deacetylase

Outcome Measures

Primary Outcomes (1)

  • Response Rate

    RECIST v 1.1

    Within 6 to 8 weeks after completion of chemoradiation

Secondary Outcomes (5)

  • Adverse reactions to study treatment

  • Progression free survival

    Three years

  • Overall survival

    Three Years

  • Response rate comparison by p16 status

  • Quality of life

Other Outcomes (1)

  • Biomarkers assessment

Study Arms (1)

valproic acid

EXPERIMENTAL
Drug: Valproic Acid

Interventions

Valproic AcidDRUG
Also known as: sodium valproate
valproic acid

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto do Cancer do Estado de Sao Paulo

São Paulo, São Paulo, 05409-011, Brazil

Location

Related Publications (1)

  • Mak 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: 33574900DERIVED

MeSH Terms

Conditions

Head and Neck NeoplasmsMouth NeoplasmsOropharyngeal Neoplasms

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Milena P Mak, MD

    Instituto do Cancer do Estado de Sao Paulo - University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 25, 2012

First Posted

September 27, 2012

Study Start

September 1, 2012

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

February 23, 2016

Record last verified: 2016-02

Locations

BR(1)