Back to resultsA Phase II Study to Evaluate Low-Dose Fractionated Radiotherapy (LDFRT)
Primary Purpose
Squamous Cell Carcinoma of the Head and Neck
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Low-Dose Fractionated Radiation Therapy/Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Squamous Cell Carcinoma of the Head and Neck
Eligibility Criteria
Inclusion Criteria:
- Subject 18 years of age and older, male or female, of all races and ethnicities.
- Subject with prior histologically confirmed advanced squamous-cell carcinoma of the head and neck that failed prior traditional chemoradiotherapy with at least a 3-month disease-free interval from the completion of the initial curative treatment.
- Recurrence must have been confirmed via biopsy.
- Subject must have an ECOG performance status of 0, 1 or 2.
- Has undergone CT imaging within 21 days prior to treatment as part of routine care.
- Measurable disease by CT.
- Subject deemed likely to survive for at least 6 months.
- Subject is able and willing to provide written informed consent to participate in the study.
- If the subject is a female of childbearing age, the subject should have a negative urine pregnancy test and be practicing strict birth control (estrogen-containing oral contraceptives or an intrauterine device) throughout the study and for 3 months after completion of protocol treatment. Women who have had a hysterectomy are exempt from these requirements. This is routine for any patient undergoing treatment.
- History of laboratory criteria as specified below (within 21 days prior to enrollment) Hemoglobin ≥ 9 g/dl Platelet count >100,000 per microliter CO2 (carbon dioxide): 22-32 meq/L Creatinine: < 1.5 mg/dL or eGFR>40 ml/min Serum bilirubin <1.6 mg/dl. White blood count > 3,000 per microliter or ANC > 1500 per microliter Serum calcium <10.5 mg/dl.
Exclusion Criteria:
- The tumor is not clearly shown on diagnostic imaging studies
- Subject is pregnant.
- Subject with known allergies/hypersensitivity to paclitaxel.
- Subjects with poor renal function as demonstrated by serum creatinine (>1.5 mg/dl) and EGFR <40 mL/min, which would preclude the using of image contrast agents.
- Subject with a planned surgical procedure within the next 30 days.
- Subject has distant metastasis (with the exception of single stable distant metastasis that does not decrease life expectancy to less than 6 months).
- Subject is of childbearing potential and will not use adequate contraceptive protection.
- Subject who is breastfeeding.
- Subject of childbearing potential who has a positive (+) urine pregnancy test.
- Subject has received treatment with an experimental drug or entered another clinical trial within the prior 30 days.
- Subject has received radiotherapy to the head and neck region within the prior 3 months.
- Subject is not willing or able to complete the visit requirements of this protocol.
- Peripheral neuropathy of any etiology.
- Any other condition that the PI feels will be an endangerment to the subject.
Sites / Locations
- University of Arkansas for Medical Sciences
Outcomes
Primary Outcome Measures
Objective Response (OR)
Objective Response (OR). OR will be defined according to RECIST v1.1 criteria as either a complete or partial response. OR will be determined in each subject 3 months following therapy using CT imaging performed for clinical-care purposes.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01820312
Brief Title
A Phase II Study to Evaluate Low-Dose Fractionated Radiotherapy (LDFRT)
Official Title
A Phase II Study to Evaluate Low-Dose Fractionated Radiotherapy (LDFRT) and Chemotherapy in Recurrent and Inoperable Squamous Cell Carcinoma (SCC) of the Head and Neck After Radiotherapy Failure
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Due to no enrollment.
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if low-dose radiation therapy and the chemotherapy drug paclitaxel is effective in treating head and neck cancer that has returned after treatment with standard radiation therapy alone, but cannot be removed by surgery. The overall total dose received of both the chemotherapy and radiation therapy will be less than that typically given as standard of care; however, the Food and Drug Administration (FDA) has not evaluated the safety and effectiveness of this combination therapy. In addition, this study will gather information about the effects of radiation therapy and chemotherapy on subject's overall quality of life.
Detailed Description
This study will evaluate a combination therapy of paclitaxel and LDFRT. The paclitaxel will be commercially available drug product dispensed by a licensed pharmacist at UAMS. Radiotherapy will be delivered using either the TomoTherapy Treatment System (TomoTherapy, Inc.) or the Varian High Energy Linear Accelerator (Varian Medical Systems).
Subjects will undergo CT imaging (to include neck, chest, abdomen and pelvis) as part of the standard of care approximately 7 to 21 days prior to initiation of this therapy. Additional CT imaging will be done at UAMS approximately 3 months after completion of protocol therapy and every 3 months subsequently until progression or completion of the study whichever comes first. These CT imaging's will be obtained for recurrent tumor evaluation and determination of the presence or absence of distant metastasis, as part of the standard of care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of the Head and Neck
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Radiation
Intervention Name(s)
Low-Dose Fractionated Radiation Therapy/Paclitaxel
Primary Outcome Measure Information:
Title
Objective Response (OR)
Description
Objective Response (OR). OR will be defined according to RECIST v1.1 criteria as either a complete or partial response. OR will be determined in each subject 3 months following therapy using CT imaging performed for clinical-care purposes.
Time Frame
OR will be determined in each subject 3 months following therapy using CT imaging performed for clinical-care purposes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject 18 years of age and older, male or female, of all races and ethnicities.
Subject with prior histologically confirmed advanced squamous-cell carcinoma of the head and neck that failed prior traditional chemoradiotherapy with at least a 3-month disease-free interval from the completion of the initial curative treatment.
Recurrence must have been confirmed via biopsy.
Subject must have an ECOG performance status of 0, 1 or 2.
Has undergone CT imaging within 21 days prior to treatment as part of routine care.
Measurable disease by CT.
Subject deemed likely to survive for at least 6 months.
Subject is able and willing to provide written informed consent to participate in the study.
If the subject is a female of childbearing age, the subject should have a negative urine pregnancy test and be practicing strict birth control (estrogen-containing oral contraceptives or an intrauterine device) throughout the study and for 3 months after completion of protocol treatment. Women who have had a hysterectomy are exempt from these requirements. This is routine for any patient undergoing treatment.
History of laboratory criteria as specified below (within 21 days prior to enrollment) Hemoglobin ≥ 9 g/dl Platelet count >100,000 per microliter CO2 (carbon dioxide): 22-32 meq/L Creatinine: < 1.5 mg/dL or eGFR>40 ml/min Serum bilirubin <1.6 mg/dl. White blood count > 3,000 per microliter or ANC > 1500 per microliter Serum calcium <10.5 mg/dl.
Exclusion Criteria:
The tumor is not clearly shown on diagnostic imaging studies
Subject is pregnant.
Subject with known allergies/hypersensitivity to paclitaxel.
Subjects with poor renal function as demonstrated by serum creatinine (>1.5 mg/dl) and EGFR <40 mL/min, which would preclude the using of image contrast agents.
Subject with a planned surgical procedure within the next 30 days.
Subject has distant metastasis (with the exception of single stable distant metastasis that does not decrease life expectancy to less than 6 months).
Subject is of childbearing potential and will not use adequate contraceptive protection.
Subject who is breastfeeding.
Subject of childbearing potential who has a positive (+) urine pregnancy test.
Subject has received treatment with an experimental drug or entered another clinical trial within the prior 30 days.
Subject has received radiotherapy to the head and neck region within the prior 3 months.
Subject is not willing or able to complete the visit requirements of this protocol.
Peripheral neuropathy of any etiology.
Any other condition that the PI feels will be an endangerment to the subject.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Penagaricano, MD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rick
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Phase II Study to Evaluate Low-Dose Fractionated Radiotherapy (LDFRT)
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