Back to resultsA Study of Chemo +/- Low-dose Radiation as Induction Therapy in SCCHN
Primary Purpose
Head and Neck Cancer, Larynx
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Low dose fractionated radiation - 80cGy with chemotherapy
Docetaxel and Carboplatin AUC 6
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring Cancer, Low dose radiation
Eligibility Criteria
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
Sites / Locations
- University of Kentucky, Markey Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Chemotherapy plus Radiation Therapy
Chemotherapy without Radiation
Arm Description
Low dose fractionated radiation - 80cGy with chemotherapy
Chemotherapy only
Outcomes
Primary Outcome Measures
Primary Site Complete Response Rate
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.
Secondary Outcome Measures
Overall Response Rate
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).
Change in Quality of Life (QOL) of Patients Receiving Low Dose Fractionated Radiation Therapy With Chemotherapy.
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.
Physical; scores range from 7-35; higher scores indicate increased well-being
Social/family; scores range from 7-35; higher scores indicate increased well-being
Emotional; scores range from 6-30; higher scores indicate increased well-being
Functional; scores range from 7-35; higher scores indicate increased well-being
Additional Concerns; scores range from 10-50; lower scores indicate increased well-being
FACT-G is the sum of the first 4 scores; scores range from 27-135; higher scores indicated increased well-being
FACT-H&N is the sum of the first five scores; scores range from 37-185; higher scores indicated increased well-being
Trial Outcome Index is the sum of 1, 4 and 5; scores range from 24-120; higher scores indicated increased well-being
3-year Overall Survival
3-year overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02126969
Brief Title
A Study of Chemo +/- Low-dose Radiation as Induction Therapy in SCCHN
Official Title
A Phase II Study of Docetaxel, Carboplatin With and Without Low Dose Radiation as Induction Therapy in Locally Advanced Head and Neck Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
June 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Susanne Arnold
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary hypothesis of this study is that hyper-radiosensitivity (HRS) seen at extremely low doses of radiation can be exploited to enhance the effect of chemotherapy, and that this effect differs from the cellular effect of higher, standard fractions of radiation used in traditional radiation treatment paradigms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Larynx
Keywords
Cancer, Low dose radiation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chemotherapy plus Radiation Therapy
Arm Type
Experimental
Arm Description
Low dose fractionated radiation - 80cGy with chemotherapy
Arm Title
Chemotherapy without Radiation
Arm Type
Active Comparator
Arm Description
Chemotherapy only
Intervention Type
Radiation
Intervention Name(s)
Low dose fractionated radiation - 80cGy with chemotherapy
Intervention Description
Chemotherapy + 80 cGy of RT
Intervention Type
Drug
Intervention Name(s)
Docetaxel and Carboplatin AUC 6
Intervention Description
Docetaxel 75 mg/m2 and Carboplatin AUC 6 without Radiation
Primary Outcome Measure Information:
Title
Primary Site Complete Response Rate
Description
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.
Time Frame
Up to 50 days
Secondary Outcome Measure Information:
Title
Overall Response Rate
Description
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).
Time Frame
Up to 50 days
Title
Change in Quality of Life (QOL) of Patients Receiving Low Dose Fractionated Radiation Therapy With Chemotherapy.
Description
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.
Physical; scores range from 7-35; higher scores indicate increased well-being
Social/family; scores range from 7-35; higher scores indicate increased well-being
Emotional; scores range from 6-30; higher scores indicate increased well-being
Functional; scores range from 7-35; higher scores indicate increased well-being
Additional Concerns; scores range from 10-50; lower scores indicate increased well-being
FACT-G is the sum of the first 4 scores; scores range from 27-135; higher scores indicated increased well-being
FACT-H&N is the sum of the first five scores; scores range from 37-185; higher scores indicated increased well-being
Trial Outcome Index is the sum of 1, 4 and 5; scores range from 24-120; higher scores indicated increased well-being
Time Frame
Up to 50 days (pre- and post-treatment)
Title
3-year Overall Survival
Description
3-year overall survival
Time Frame
From date of randomization until date of death from any cause, assessed up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne M Arnold, MD
Organizational Affiliation
Lucille P. Markey Cancer Center at University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky, Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Chemo +/- Low-dose Radiation as Induction Therapy in SCCHN
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