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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01682031




Registration number
NCT01682031
Ethics application status
Date submitted
5/09/2012
Date registered
10/09/2012
Date last updated
22/08/2014

Titles & IDs
Public title
Selenomethionine in Reducing Mucositis in Patients With Locally Advanced Head and Neck Cancer Who Are Receiving Cisplatin and Radiation Therapy
Scientific title
Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase II Trial of Selenomethionine as a Modulator of Efficacy and Toxicity of Chemoradiation in Locally-Advanced Squamous Cell Carcinoma of the Head and Neck
Secondary ID [1] 0 0
NCI-2009-01503
Secondary ID [2] 0 0
I 107807
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chemotherapeutic Agent Toxicity 0 0
Mucositis 0 0
Radiation Toxicity 0 0
Stage III Squamous Cell Carcinoma of the Hypopharynx 0 0
Stage III Squamous Cell Carcinoma of the Larynx 0 0
Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity 0 0
Stage III Squamous Cell Carcinoma of the Nasopharynx 0 0
Stage III Squamous Cell Carcinoma of the Oropharynx 0 0
Stage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity 0 0
Stage IV Squamous Cell Carcinoma of the Hypopharynx 0 0
Stage IV Squamous Cell Carcinoma of the Larynx 0 0
Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity 0 0
Stage IV Squamous Cell Carcinoma of the Nasopharynx 0 0
Stage IV Squamous Cell Carcinoma of the Oropharynx 0 0
Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity 0 0
Xerostomia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - selenomethionine
Other interventions - placebo
Treatment: Drugs - cisplatin
Treatment: Other - radiation therapy
Treatment: Surgery - quality-of-life assessment

Placebo comparator: Arm I (placebo, cisplatin, and radiotherapy) - Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.

Experimental: Arm II (selenomethionine, cisplatin, and radiotherapy) - Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.


Treatment: Other: selenomethionine
Given PO

Other interventions: placebo
Given PO

Treatment: Drugs: cisplatin
Given IV

Treatment: Other: radiation therapy
Undergo radiotherapy

Treatment: Surgery: quality-of-life assessment
Ancillary studies
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Intervention code [3] 0 0
Treatment: Drugs
Intervention code [4] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of >= Grade 3 Mucositis
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [1] 0 0
Tumor Complete Response Rate
Timepoint [1] 0 0
Up to 5 years post-treatment
Secondary outcome [2] 0 0
Relapse-free Survival (RFS)
Timepoint [2] 0 0
At 1 year
Secondary outcome [3] 0 0
Overall Survival
Timepoint [3] 0 0
Up to 5 years post-treatment
Secondary outcome [4] 0 0
Quality of Life
Timepoint [4] 0 0
Up to 1 year post-treatment
Secondary outcome [5] 0 0
Incidence of Grade 3 or 4 Treatment-related Toxicities, Including Xerostomia
Timepoint [5] 0 0
Up to 5 years post-treatment
Secondary outcome [6] 0 0
CRT Dose Delivery
Timepoint [6] 0 0
Up to 8 weeks
Secondary outcome [7] 0 0
Plasma Cisplatin and Selenium PK and PD Markers (NZ Only)
Timepoint [7] 0 0
Up to 3 months post-treatment

Eligibility
Key inclusion criteria
* Biopsy-proven locally-advanced HNSCC, including those with cancers of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx or paranasal sinuses
* Stage III, IVa or IVb disease
* No prior definitive surgery for present diagnosis
* Appropriate candidate for concurrent cisplatin and radiation as definitive treatment; patients who receive induction chemotherapy as part of a definitive treatment program that will include concurrent CRT are eligible for this study
* Hemoglobin >= 10 g/dL (100 g/l)
* Absolute neutrophil count >= 2,000 cells/mm^3 (2 x 10^9/l)
* Platelets >= 100,000 cells/mm^3 (100 x 10^9/l)
* Serum creatinine =< 1.5 mg/dL (133 umol/l) or calculated creatinine clearance >= 50 ml/min using the Cockcroft-Gault formula
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Able to give written informed consent
* Be willing and able to comply with study procedures
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Non-regional metastatic disease (stage IVc)
* Previous malignancy within the last 5 years except for adequately treated basal or squamous cell carcinoma of the skin or cervical intra-epithelial neoplasia
* Prior chemotherapy or radiotherapy for HNSCC, or any prior radiotherapy that would compromise delivery of a radical dose to the HNSCC
* Known to be positive for hepatitis C or human immunodeficiency virus (HIV)
* Unable to tolerate oral medication (unless a feeding tube is in place)
* History of hypersensitivity to platinum drugs
* Symptomatic peripheral neuropathy >= National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) grade II
* Pregnant, lactating or unwilling to use adequate contraception
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
* Planned use of amifostine for prophylaxis against radiation-induced xerostomia
* Patients taking selenium supplements in excess of 100 ug/day
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Evidence of any other significant medical disorder or laboratory finding that in the opinion of the Investigator compromises the subject's safety during the study

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2012
Sample size
Target
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
New Zealand
State/province [2] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Other
Name
Roswell Park Cancer Institute
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This randomized phase II trial is studying how well selenomethionine (SLM) works in reducing mucositis in patients with locally advanced head and neck cancer who are receiving cisplatin and radiation therapy. SLM may help prevent or reduce mucositis, or mouth sores, in patients receiving chemotherapy and radiation therapy. It is not yet known whether SLM is more effective than a placebo in reducing mucositis
Trial website
https://clinicaltrials.gov/study/NCT01682031
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anurag Singh
Address 0 0
Roswell Park Cancer Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01682031