- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02126969
A Study of Chemo +/- Low-dose Radiation as Induction Therapy in SCCHN
A Phase II Study of Docetaxel, Carboplatin With and Without Low Dose Radiation as Induction Therapy in Locally Advanced Head and Neck Cancer
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Kentucky
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Lexington, Kentucky, United States, 40536
- University of Kentucky, Markey Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically or cytologically confirmed locally advanced head and neck cancer of squamous type stage III, IVA and IV B and select Stage II tumors of the BOT who are appropriate for potentially curative therapy with chemoradiotherapy.
- Measurable disease.
- ECOG performance status of 0, 1 or 2
- No prior chemotherapy for the current locally advanced SCCHN.
- Age ≥18 years.
- Life expectancy of greater than 3 months
Normal organ and marrow function measured within 14 days of registration as defined below:
- absolute neutrophil count ≥ 1,000/mcL
- platelets ≥ 100,000/mcL
- total bilirubin < institutional upper limit of normal
- AST(SGOT ≤ 2.5 × institutional upper limit of normal
- Alkaline phosphatase ≤ 2.5 × institutional upper limit of normal
- creatinine within normal institutional limits
OR
o Creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
- 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, throughout the duration of active treatment and for 4 months after completion of chemotherapy and radiation. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of active study treatment, and for 4 months after completion of chemotherapy and radiation (both induction and definitive) administration.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Prior chemotherapy for SCCHN
- Patients who are receiving any other investigational agents.
- Patients with known brain metastases
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Carboplatin or Docetaxel.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women
- HIV-positive patients on combination antiretroviral therapy
- Other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated previous Stage I or II cancer from which the patient is currently in complete remission or other cancer from which the patient has been disease-free for 3 years.
- Patients with nasopharynx or salivary gland primary site
- Patients with distant metastatic disease (M1c)
- Patients with grade II or greater peripheral neuropathy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Chemotherapy plus Radiation Therapy
Low dose fractionated radiation - 80cGy with chemotherapy
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Chemotherapy + 80 cGy of RT
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Active Comparator: Chemotherapy without Radiation
Chemotherapy only
|
Docetaxel 75 mg/m2 and Carboplatin AUC 6 without Radiation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Site Complete Response Rate
Time Frame: Up to 50 days
|
Primary site is defined as the original, or first site that the cancer developed in the body.
In this study, primary sites within the head and neck included squamous cancers of the larynx, oral cavity, oropharynx, hypopharynx.Complete response rate in patients treated with 2 cycles of induction Docetaxel and Carboplatin with low dose fractionated radiation therapy (LDFRT) will be compared to those treated with chemotherapy alone.
CRR was determined Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Where possible, surgeon also evaluated primary site and provided response assessment.
|
Up to 50 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate
Time Frame: Up to 50 days
|
To assess overall response rate of patients to 2 cycles of induction Docetaxel and Carboplatin with or without LDFRT.
Response assessment was Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, and Progressive Disease (PD): > 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).
(Note: the appearance of one or more new lesions is also considered progression).
|
Up to 50 days
|
Change in Quality of Life (QOL) of Patients Receiving Low Dose Fractionated Radiation Therapy With Chemotherapy.
Time Frame: Up to 50 days (pre- and post-treatment)
|
Quality of Life (QOL) will be measured pre- and post-treatment using a single 5-question QOL well-being survey. The change in score will be presented independently for each subpart of the QOL survey.
|
Up to 50 days (pre- and post-treatment)
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3-year Overall Survival
Time Frame: From date of randomization until date of death from any cause, assessed up to 3 years
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3-year overall survival
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From date of randomization until date of death from any cause, assessed up to 3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Susanne M Arnold, MD, Lucille P. Markey Cancer Center at University of Kentucky
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 (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCC-13-HN-24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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