Head and Neck CancerPhase 2NCT01695122
Valproic Acid and Platinum-based Chemoradiation in Locally Advanced Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing Valproic Acid in people with Head and Neck Cancer and Oral Cavity Cancer, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Head and Neck Cancer, Oral Cavity Cancer, Oropharyngeal Cancer
- What is being tested?
- Valproic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2012to Nov 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Cancer do Estado de Sao Paulo
São Paulo, São Paulo, 05409-011
About this study
Official title: Efficacy Evaluation of the Combination of Valproic Acid and Standard Platinum-based Chemoradiation in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
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.
Read the detailed description
Valproic acid is a known histone deacetylase inhibitor. In addition to activating apoptosis pathways, cell differentiation and downregulating expression of growth factors, it also promotes radiosensitization.
Most patients with Head and Neck squamous cell carcinoma are diagnosed with locally advanced disease, in which long term disease control is still a challenge. The incorporation of epigenetic regulation into standard treatment could improve results of definitive platinum-based chemoradiation in such patients.
- Being tested
- Valproic Acid
- Keywords
- Head and Neck Cancer, Oropharyngeal cancer, Oral cavity cancer, Chemoradiation, valproic acid, histone deacetylase
- Medical subject headings
- Head and Neck Neoplasms, Mouth Neoplasms, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valproic AcidDrug
Also called sodium valproate
| Study group | Role | What they receive |
|---|---|---|
| valproic acid | Experimental | Not described Receives: Drug: Valproic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
RECIST v 1.1
Measured: Within 6 to 8 weeks after completion of chemoradiation
Secondary outcomes (5)
Adverse reactions to study treatment
Progression free survival
Measured: Three years
Overall survival
Measured: Three Years
Response rate comparison by p16 status
Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Principal investigator, Milena Mak, Instituto do Cancer do Estado de São Paulo
- Investigators
- Milena P Mak, MD, Principal investigator, Instituto do Cancer do Estado de Sao Paulo - University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695122
- Sponsor's protocol ID
- 327/11
- Status last verified
- Feb 2016
- First submitted
- 25 Sep 2012
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33574900
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of the Combination of Valproic Acid and Standard Platinum-based Chemoradiation in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01695122
- Acronym / sponsor ID
- 327/11
- Keywords
- Head and Neck Cancer, Oropharyngeal cancer, Oral cavity cancer, Chemoradiation, valproic acid, histone deacetylase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- Sep 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 27 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Valproic acid is a known histone deacetylase inhibitor. In addition to activating apoptosis pathways, cell differentiation and downregulating expression of growth factors, it also promotes radiosensitization.
Most patients with Head and Neck squamous cell carcinoma are diagnosed with locally advanced disease, in which long term disease control is still a challenge. The incorporation of epigenetic regulation into standard treatment could improve results of definitive platinum-based chemoradiation in such patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| valproic acid | Experimental | Drug: Valproic Acid |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (8 listed)
- Pregnancy
- Distant metastasis
- Hypersensibility to valproic acid or other antiepileptic drugs
- Valproic acid chronic use
- Severe neurologic impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valproic AcidAlso: sodium valproate | Drug | valproic acid |
Primary outcome
Response Rate
Time frame: Within 6 to 8 weeks after completion of chemoradiation
RECIST v 1.1
5 secondary outcomes
Adverse reactions to study treatment
Progression free survival
Time frame: Three years
Overall survival
Time frame: Three Years
Response rate comparison by p16 status
Quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
- Derived from this study: PubMed 33574900Mak 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milena P Mak, MD principal investigator
Instituto do Cancer do Estado de Sao Paulo - University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Valproic Acid in people with Head and Neck Cancer and Oral Cavity Cancer, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (time frame: Within 6 to 8 weeks after completion of chemoradiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01695122, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2016.