Chemotherapeutic Agent ToxicityPhase 2NCT01682031
Selenomethionine in Reducing Mucositis in Patients With Locally Advanced Head and Neck Cancer Who Are Receiving Cisplatin and Radiation Therapy
A Phase 2 study testing selenomethionine, cisplatin and radiation therapy in people with Chemotherapeutic Agent Toxicity and Mucositis, run by Roswell Park Cancer Institute at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapeutic Agent Toxicity, Mucositis, Radiation Toxicity
- What is being tested?
- selenomethionine, cisplatin and radiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2009to Jun 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official 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
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
Read the detailed description
PRIMARY OBJECTIVES:
- To assess whether SLM reduces the incidence of grade 3 or 4 mucositis in head and neck squamous cell carcinoma (HNSCC) patients treated with concurrent chemoradiation (CRT) over 7 weeks.
SECONDARY OBJECTIVES:
- To assess the impact of SLM on tumor complete response rate, relapse-free survival, overall survival and quality of life.
II. To assess whether SLM reduces the incidence and severity of treatment-related toxicities including xerostomia, renal impairment and myelosuppression.
III. To assess whether SLM improves chemoradiation dose delivery. IV. To determine safety of SLM at this dose. V. In New Zealand (NZ) patients only, to assess the impact of SLM on plasma free cisplatin and plasma selenium pharmacokinetics (PK) and on pharmacodynamic (PD) markers of biological activity of selenium.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive placebo orally (PO) twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin intravenously (IV) over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.
ARM II: 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.
After completion of study treatment, patients are followed up periodically.
- Conditions
- Chemotherapeutic Agent Toxicity, Mucositis, Radiation Toxicity, Stage III Squamous Cell Carcinoma of the Hypopharynx, Stage III Squamous Cell Carcinoma of the Larynx, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
- Being tested
- selenomethionine, placebo, cisplatin, radiation therapy, quality-of-life assessment
- Medical subject headings
- Mucositis, Radiation Injuries, Squamous Cell Carcinoma of Head and Neck, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selenomethionineDietary supplement
Given PO
placeboOther
Also called PLCB
Given PO
cisplatinDrug
Also called CACP, CDDP, CPDD, DDP
Given IV
radiation therapyRadiation
Also called irradiation, radiotherapy, therapy, radiation
Undergo radiotherapy
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (placebo, cisplatin, and radiotherapy) | Placebo comparator | 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. Receives: Other: placebo; Drug: cisplatin; Radiation: radiation therapy; Procedure: quality-of-life assessment |
| Arm II (selenomethionine, cisplatin, and radiotherapy) | Experimental | 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. Receives: Dietary Supplement: selenomethionine; Drug: cisplatin; Radiation: radiation therapy; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of >= Grade 3 Mucositis
Will be compared as difference in proportions with 95% confidence intervals.
Measured: Up to 5 years
Secondary outcomes (7)
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).
Measured: Up to 5 years post-treatment
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.
Measured: At 1 year
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.
Measured: Up to 5 years post-treatment
Quality of Life
Measured: Up to 1 year post-treatment
Incidence of Grade 3 or 4 Treatment-related Toxicities, Including Xerostomia
Will be compared as difference in proportions with 95% confidence intervals.
Measured: Up to 5 years post-treatment
CRT Dose Delivery
This characteristic will be included in Cox models.
Measured: Up to 8 weeks
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.
Measured: Up to 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study startJun 2009
- Primary completionApr 2012
- Study completionJun 2012
Why it stopped: Due to a lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chemotherapeutic Agent ToxicityStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Anurag Singh, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682031
- Sponsor's protocol ID
- I 107807
- Other IDs
- NCI-2009-01503
- Status last verified
- Aug 2014
- First submitted
- 5 Sep 2012
- Last updated
- 22 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01682031
- Acronym / sponsor ID
- I 107807
- Conditions
- Chemotherapeutic Agent Toxicity, Mucositis, Radiation Toxicity, Stage III Squamous Cell Carcinoma of the Hypopharynx, Stage III Squamous Cell Carcinoma of the Larynx, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to a lack of funding
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 10 Sep 2012 (estimated)
- Results
- Posted 22 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
PRIMARY OBJECTIVES:
- To assess whether SLM reduces the incidence of grade 3 or 4 mucositis in head and neck squamous cell carcinoma (HNSCC) patients treated with concurrent chemoradiation (CRT) over 7 weeks.
SECONDARY OBJECTIVES:
- To assess the impact of SLM on tumor complete response rate, relapse-free survival, overall survival and quality of life.
II. To assess whether SLM reduces the incidence and severity of treatment-related toxicities including xerostomia, renal impairment and myelosuppression.
III. To assess whether SLM improves chemoradiation dose delivery. IV. To determine safety of SLM at this dose. V. In New Zealand (NZ) patients only, to assess the impact of SLM on plasma free cisplatin and plasma selenium pharmacokinetics (PK) and on pharmacodynamic (PD) markers of biological activity of selenium.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive placebo orally (PO) twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin intravenously (IV) over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.
ARM II: 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.
After completion of study treatment, patients are followed up periodically.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (placebo, cisplatin, and radiotherapy) | Placebo comparator | Other: placebo, Drug: cisplatin, Radiation: radiation therapy, Procedure: quality-of-life assessmentPatients 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. |
| Arm II (selenomethionine, cisplatin, and radiotherapy) | Experimental | Dietary Supplement: selenomethionine, Drug: cisplatin, Radiation: radiation therapy, Procedure: quality-of-life assessmentPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (13 listed)
- 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)
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 |
|---|---|---|
| selenomethionineGiven PO | Dietary supplement | Arm II (selenomethionine, cisplatin, and radiotherapy) |
| placeboAlso: PLCBGiven PO | Other | Arm I (placebo, cisplatin, and radiotherapy) |
| cisplatinAlso: CACP, CDDP, CPDD, DDPGiven IV | Drug | Arm I (placebo, cisplatin, and radiotherapy), Arm II (selenomethionine, cisplatin, and radiotherapy) |
| radiation therapyAlso: irradiation, radiotherapy, therapy, radiationUndergo radiotherapy | Radiation | Arm I (placebo, cisplatin, and radiotherapy), Arm II (selenomethionine, cisplatin, and radiotherapy) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Arm I (placebo, cisplatin, and radiotherapy), Arm II (selenomethionine, cisplatin, and radiotherapy) |
Primary outcome
Incidence of >= Grade 3 Mucositis
Time frame: Up to 5 years
Will be compared as difference in proportions with 95% confidence intervals.
7 secondary outcomes
Tumor Complete Response Rate
Time frame: Up to 5 years post-treatment
Relapse-free Survival (RFS)
Time frame: At 1 year
Overall Survival
Time frame: Up to 5 years post-treatment
Quality of Life
Time frame: Up to 1 year post-treatment
Incidence of Grade 3 or 4 Treatment-related Toxicities, Including Xerostomia
Time frame: Up to 5 years post-treatment
CRT Dose Delivery
Time frame: Up to 8 weeks
Plasma Cisplatin and Selenium PK and PD Markers (NZ Only)
Time frame: Up to 3 months post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Anurag Singh principal investigator
Roswell Park Cancer Institute
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing selenomethionine, cisplatin and radiation therapy in people with Chemotherapeutic Agent Toxicity and Mucositis, run by Roswell Park Cancer Institute at 2 sites in 2 countries.
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 11 inclusion and 13 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: stopped early, as of the sponsor's last update on 22 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, New Zealand. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 22 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of >= Grade 3 Mucositis (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2014.