- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04541355
Sodium Thiosulfate in Preventing Ototoxicity for Squamous Cell Cancer Patients Undergoing Chemoradiation With Cisplatin
A Phase II Study of Sodium Thiosulfate (STS) for Prevention of Ototoxicity in Patients With Locally Advanced Squamous Cell Carcinoma of Head and Neck (SCCHN) Undergoing Concurrent Chemoradiation With Cisplatin
Study Overview
Status
Conditions
- Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Stage III Hypopharyngeal Carcinoma AJCC v8
- Stage III Laryngeal Cancer AJCC v8
- Stage III Lip and Oral Cavity Cancer AJCC v8
- Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage IV Hypopharyngeal Carcinoma AJCC v8
- Stage IV Laryngeal Cancer AJCC v8
- Stage IV Lip and Oral Cavity Cancer AJCC v8
- Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage IVA Lip and Oral Cavity Cancer AJCC v8
- Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Pathologic Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Stage IVA Hypopharyngeal Carcinoma AJCC v8
- Stage IVA Laryngeal Cancer AJCC v8
- Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage IVB Hypopharyngeal Carcinoma AJCC v8
- Stage IVB Laryngeal Cancer AJCC v8
- Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage IVC Hypopharyngeal Carcinoma AJCC v8
- Stage IVC Laryngeal Cancer AJCC v8
- Stage IVC Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Locally Advanced Head and Neck Squamous Cell Carcinoma
- Locally Advanced Hypopharyngeal Squamous Cell Carcinoma
- Locally Advanced Laryngeal Squamous Cell Carcinoma
- Locally Advanced Oropharyngeal Squamous Cell Carcinoma
- Clinical Stage III Human Papillomavirus (HPV)-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Locally Advanced Oral Cavity Squamous Cell Carcinoma
- Stage IVB Lip and Oral Cavity Cancer AJCC v8
- Stage IVC Lip and Oral Cavity Cancer AJCC v8
Detailed Description
PRIMARY OBJECTIVE:
I. To establish feasibility of intravenous sodium thiosulfate (STS) after each dose of concurrent cisplatin in patients with locally advanced head and neck squamous cell carcinoma undergoing definitive radiotherapy.
SECONDARY OBJECTIVES:
I. To determine the rate of grade >= 2 hearing impairment based on Common Terminology Criteria for Adverse Events (CTCAE) version 5 with use of STS after concurrent chemoradiation with cisplatin 3 months post-treatment.
II. To determine the rate of tinnitus measured by Patient Reported Outcomes (PRO)-CTCAE with use of STS 3 months post-treatment.
III. To describe patient reported outcomes with STS measured with PRO-CTCAE for selected oral, gastrointestinal (GI), neurologic and perceptual symptoms.
IV. To describe patient reported outcomes measured with Hearing Handicap Inventory for Adults - Screening (HHIA-S) compared to results from standard NRG Oncology head and neck trials (such as Radiation Therapy Oncology Group (RTOG) 1016).
OUTLINE:
Patients undergo standard of care radiation therapy in combination with cisplatin therapy for up to 6-7 weeks. Cisplatin treatment repeats weekly for up to 7 cycles, or every 21 days for up to 3 cycles. After each cisplatin infusion, patients also receive an infusion of sodium thiosulfate. The dosing schedule for cisplatin will be at the discretion of the treating physician.
After completion of study treatment, patients are followed up every 3 months for up to 3 years.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94143
- University of California, San Francisco
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants must have histologically or cytologically confirmed locoregionally advanced squamous cell carcinomas of mucosal surfaces of head and neck who are being treated with concurrent chemoradiation with cisplatin
- Participants must be eligible for cisplatin-based concurrent chemotherapy in conjunction with at least 6 weeks of daily fractionated radiation therapy
- Age >=18 years
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 50%)
Demonstrates adequate organ function as defined below:
- Absolute neutrophil count >= 1,000/microliter (mcL)
- Platelets >= 100,000/mcL
- Total bilirubin within normal institutional limits, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits
- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase (SGOT)) =< 3 X institutional upper limit of normal
- Alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase (SGPT)) =< 3 X institutional upper limit of normal
- Creatinine =< 1.5 x within institutional upper limit of normal OR creatinine clearance glomerular filtration rate (GFR) >= 60 mL/min/1.73 m^2, calculated using the Cockcroft-Gault equation, unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m^2
- Ability to understand a written informed consent document, and the willingness to sign it
- Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- The effects of sodium thiosulfate (STS) on the developing human fetus are unknown. For this reason and because cisplatin used in this trial are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception such as hormonal and/or barrier method of birth control for the duration of study participation and for 3 months after last administration of study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after last administration of study treatment
Exclusion Criteria:
- Participants that are not eligible for cisplatin-based chemoradiation for reasons such as chronic kidney disease, severe hearing loss, and severe peripheral neuropathy
- Uncontrolled inter-current illness or psychiatric illness/social situation that would limit compliance with study requirements
- Has known hypersensitivity to cisplatin, sodium thiosulfate or any of its excipients
- Has profound hearing impairment at baseline and cannot hear a sound below 90 decibels (dB)
- Participants with uncompensated congestive heart failure New York Heart Association (NYHA) class 3 or above
- Participants who cannot get secure venous access using either a Mediport or a peripherally inserted central catheter (PICC) line for safe administration of intravenous sodium thiosulfate
- Pregnant women are excluded from this study because cisplatin is a cytotoxic agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cisplatin or sodium thiosulfate, breastfeeding should be discontinued if the mother is treated with either agent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cisplatin, Radiotherapy, STS
Patients undergo standard of care radiation therapy daily in combination with cisplatin on day 1.
Between 4-5 hours after each cisplatin infusion, patients also receive sodium thiosulfate over 1-2 hours on day 1.
Treatment will continue on either a 1 week or 3 week cycle per physician discretion for up to 6-7 weeks in the absence of disease progression or unacceptable toxicity.
|
Given IV
Other Names:
Given IV
Other Names:
Patient self-assessment questionnaire to measure probability of hearing impairment
Radiation therapy will be delivered according to the standard of care
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients who successfully completed planned treatment
Time Frame: Up to 7 weeks
|
Evaluated as the successful completion of at least 5 weekly cisplatin or 2 high dose cisplatin without any extended treatment related delays more than 7 days.
Overall successful completion is defined as completion by at least 75% of patients.
|
Up to 7 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of participants with reported high grade ototoxicity
Time Frame: Up to 18 weeks
|
The proportion of participants with a reported change of grade >= 2 hearing impairments based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (for patients on a monitoring program with audiogram) will be reported with 95% confidence intervals.
|
Up to 18 weeks
|
Proportion of participants reporting tinnitus by severity
Time Frame: Up to 18 weeks
|
The frequency of tinnitus will be measured by participant responses on the PRO-CTCAE® question "In the last 7 days, what was the SEVERITY of RINGING IN YOUR EARS at its WORST?".
Responses are categorized and will be reported as 'None', 'Mild', 'Moderate', 'Severe', and 'Very Severe'.
|
Up to 18 weeks
|
Proportion of participants reporting STS-specific symptomology
Time Frame: Up to 18 weeks
|
The proportion of participants reporting STS specific adverse events will be measured by affirmative responses on the PRO-CTCAE® on any of the selected oral, gastrointestinal, neurologic and visual/perceptual symptoms
|
Up to 18 weeks
|
Mean Scores on then Hearing Handicap Inventory for Adults - Screening (HHIA-S)
Time Frame: Up to 18 weeks
|
The Hearing Handicap Inventory for Adults (HHIA), is a 25-item self-assessment scale composed of two subscales (emotional and social/situational) and a total score.
The Participants respond to each items with a Yes (4), Sometimes (2), or No (0).
Scores are then summed and divided by the total points possible for overall (100), the social subscale (48) and then Emotional subscale (52).
The scores are then reported as a percentage ranging from 0-100, with scores of 0%-16% = No handicap, 18%-42%= Mild-Moderate handicap, and 44% and higher indicating a significant handicap.
|
Up to 18 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Hyunseok Kang, MD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Pathologic Processes
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Wounds and Injuries
- Respiratory Tract Neoplasms
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Mouth Diseases
- Ear Diseases
- Lip Diseases
- Neoplasms, Squamous Cell
- Drug-Related Side Effects and Adverse Reactions
- Radiation Injuries
- Laryngeal Diseases
- Carcinoma
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Ototoxicity
- Mouth Neoplasms
- Oropharyngeal Neoplasms
- Laryngeal Neoplasms
- Lip Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antineoplastic Agents
- Protective Agents
- Anti-Bacterial Agents
- Antioxidants
- Antitubercular Agents
- Chelating Agents
- Sequestering Agents
- Cisplatin
- Sodium thiosulfate
- Antidotes
Other Study ID Numbers
- 20208
- NCI-2020-05752 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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