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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Other interventions - 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.


Other interventions: 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
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Treatment: Other
Intervention code [4] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of >= Grade 3 Mucositis - Will be compared as difference in proportions with 95% confidence intervals.
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [1] 0 0
Tumor Complete Response Rate - 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).
Timepoint [1] 0 0
Up to 5 years post-treatment
Secondary outcome [2] 0 0
Relapse-free Survival (RFS) - 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.
Timepoint [2] 0 0
At 1 year
Secondary outcome [3] 0 0
Overall Survival - 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.
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 - Will be compared as difference in proportions with 95% confidence intervals.
Timepoint [5] 0 0
Up to 5 years post-treatment
Secondary outcome [6] 0 0
CRT Dose Delivery - This characteristic will be included in Cox models.
Timepoint [6] 0 0
Up to 8 weeks
Secondary outcome [7] 0 0
Plasma Cisplatin and Selenium PK and PD Markers (NZ Only) - 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.
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
Gender
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
Supportive Care
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/show/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/show/NCT01682031