Clinical trial NCT02126969: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Larynx
Keywords: Cancer
Low dose radiation
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2014-04-30
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Primary Site Complete Response Rate
timeFrame: Up to 50 days
Secondary outcomes:
measure: Overall Response Rate
timeFrame: Up to 50 days
measure: Change in Quality of Life (QOL) of Patients Receiving Low Dose Fractionated Radiation Therapy With Chemotherapy.
timeFrame: Up to 50 days (pre- and post-treatment)
measure: 3-year Overall Survival
timeFrame: From date of randomization until date of death from any cause, assessed up to 3 years
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky, Markey Cancer Center
state: Kentucky
Study officials:
affiliation: Lucille P. Markey Cancer Center at University of Kentucky
name: Susanne M Arnold, MD
role: PRINCIPAL_INVESTIGATOR
References: