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A Phase II Study to Evaluate Low-Dose Fractionated Radiotherapy (LDFRT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01820312
Recruitment Status : Withdrawn (Due to no enrollment.)
First Posted : March 28, 2013
Last Update Posted : August 8, 2016
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Tracking Information
First Submitted Date  ICMJE March 21, 2013
First Posted Date  ICMJE March 28, 2013
Last Update Posted Date August 8, 2016
Study Start Date  ICMJE January 2013
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2013)
Objective Response (OR) [ Time Frame: OR will be determined in each subject 3 months following therapy using CT imaging performed for clinical-care purposes ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase II Study to Evaluate Low-Dose Fractionated Radiotherapy (LDFRT)
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Squamous Cell Carcinoma of the Head and Neck
Intervention  ICMJE Radiation: Low-Dose Fractionated Radiation Therapy/Paclitaxel
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 5, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 25, 2013)
38
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject 18 years of age and older, male or female, of all races and ethnicities.
  2. 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.
  3. Recurrence must have been confirmed via biopsy.
  4. Subject must have an ECOG performance status of 0, 1 or 2.
  5. Has undergone CT imaging within 21 days prior to treatment as part of routine care.
  6. Measurable disease by CT.
  7. Subject deemed likely to survive for at least 6 months.
  8. Subject is able and willing to provide written informed consent to participate in the study.
  9. 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.
  10. 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:

  1. The tumor is not clearly shown on diagnostic imaging studies
  2. Subject is pregnant.
  3. Subject with known allergies/hypersensitivity to paclitaxel.
  4. 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.
  5. Subject with a planned surgical procedure within the next 30 days.
  6. Subject has distant metastasis (with the exception of single stable distant metastasis that does not decrease life expectancy to less than 6 months).
  7. Subject is of childbearing potential and will not use adequate contraceptive protection.
  8. Subject who is breastfeeding.
  9. Subject of childbearing potential who has a positive (+) urine pregnancy test.
  10. Subject has received treatment with an experimental drug or entered another clinical trial within the prior 30 days.
  11. Subject has received radiotherapy to the head and neck region within the prior 3 months.
  12. Subject is not willing or able to complete the visit requirements of this protocol.
  13. Peripheral neuropathy of any etiology.
  14. Any other condition that the PI feels will be an endangerment to the subject.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01820312
Other Study ID Numbers  ICMJE 136191
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Arkansas
Study Sponsor  ICMJE University of Arkansas
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jose Penagaricano, MD University of Arkansas
PRS Account University of Arkansas
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP