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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
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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
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Secondary ID [1]
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NCI-2009-01503
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Secondary ID [2]
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0
I 107807
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chemotherapeutic Agent Toxicity
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0
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Mucositis
0
0
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Radiation Toxicity
0
0
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Stage III Squamous Cell Carcinoma of the Hypopharynx
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0
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Stage III Squamous Cell Carcinoma of the Larynx
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0
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Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
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0
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Stage III Squamous Cell Carcinoma of the Nasopharynx
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0
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Stage III Squamous Cell Carcinoma of the Oropharynx
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0
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Stage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
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0
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Stage IV Squamous Cell Carcinoma of the Hypopharynx
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0
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Stage IV Squamous Cell Carcinoma of the Larynx
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0
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Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
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0
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Stage IV Squamous Cell Carcinoma of the Nasopharynx
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0
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Stage IV Squamous Cell Carcinoma of the Oropharynx
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0
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Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
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0
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Xerostomia
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0
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Condition category
Condition code
Cancer
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0
0
0
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Non melanoma skin cancer
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Cancer
0
0
0
0
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Kidney
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Cancer
0
0
0
0
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Head and neck
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Respiratory
0
0
0
0
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Other respiratory disorders / diseases
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Oral and Gastrointestinal
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0
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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0
Other interventions
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Intervention code [3]
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Treatment: Drugs
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Intervention code [4]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of >= Grade 3 Mucositis
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Assessment method [1]
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Will be compared as difference in proportions with 95% confidence intervals.
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Timepoint [1]
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Up to 5 years
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Secondary outcome [1]
0
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Tumor Complete Response Rate
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Assessment method [1]
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Will be compared as difference in proportions with 95% confidence intervals. Disease will be measured according to the Response Evaluation Criteria in Solid Tumors (RECIST).
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Timepoint [1]
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Up to 5 years post-treatment
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Secondary outcome [2]
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Relapse-free Survival (RFS)
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Assessment method [2]
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Assessed by Kaplan-Meier RFS curves and the proportion with an event at 1 year for RFS will be compared simultaneously to obtain more global sensitivity to differences in time-to-event.
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Timepoint [2]
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At 1 year
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Secondary outcome [3]
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Overall Survival
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Assessment method [3]
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Estimated using the Kaplan-Meier method. Log-rank tests will be used for the comparison of survival distributions among study groups. Continuous endpoints will be summarized using means, standard deviations and percentiles.
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Timepoint [3]
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Up to 5 years post-treatment
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Secondary outcome [4]
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Quality of Life
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Assessment method [4]
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0
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Timepoint [4]
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0
Up to 1 year post-treatment
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Secondary outcome [5]
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Incidence of Grade 3 or 4 Treatment-related Toxicities, Including Xerostomia
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Assessment method [5]
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Will be compared as difference in proportions with 95% confidence intervals.
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Timepoint [5]
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Up to 5 years post-treatment
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Secondary outcome [6]
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CRT Dose Delivery
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Assessment method [6]
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This characteristic will be included in Cox models.
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Timepoint [6]
0
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Up to 8 weeks
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Secondary outcome [7]
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Plasma Cisplatin and Selenium PK and PD Markers (NZ Only)
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Assessment method [7]
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Descriptive statistics will be used to describe the mean plasma cisplatin and selenium at each time point. Repeated measures analysis of variance will be used to evaluate the changes in plasma cisplatin and selenium over time. Analysis of pharmacodynamic markers will be conducted using statistical methods appropriate for within-patient sequential analyses, such as repeated measures analysis of variance.
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Timepoint [7]
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Up to 3 months post-treatment
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2012
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Sample size
Target
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Accrual to date
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Final
18
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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New York
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Country [2]
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New Zealand
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State/province [2]
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Hamilton
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Funding & Sponsors
Primary sponsor type
Other
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Name
Roswell Park Cancer Institute
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Address
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Country
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Other collaborator category [1]
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Government body
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Name [1]
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National Cancer Institute (NCI)
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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
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Trial website
https://clinicaltrials.gov/study/NCT01682031
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Anurag Singh
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Address
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Roswell Park Cancer Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
0
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Address
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Country
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Phone
0
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01682031
Download to PDF