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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Squamous Cell Carcinoma of the Head and Neck

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Trial Information

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


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): 20 to 29 mmol/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 or chemotherapy 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response (OR)

Outcome 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.

Outcome Time Frame:

OR will be determined in each subject 3 months following therapy using CT imaging performed for clinical-care purposes

Authority:

United States: Institutional Review Board

Study ID:

136191

NCT ID:

NCT01820312

Start Date:

January 2013

Completion Date:

January 2016

Related Keywords:

  • Squamous Cell Carcinoma of the Head and Neck
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205