ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Chemo +/- Low-dose Radiation as Induction Therapy in SCCHN

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02126969
Recruitment Status : Recruiting
First Posted : April 30, 2014
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
Susanne Arnold, University of Kentucky

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Larynx Radiation: Low dose fractionated radiation - 80cGy with chemotherapy Drug: Docetaxel and Carboplatin AUC 6 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : October 2014
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Chemotherapy plus Radiation Therapy
Low dose fractionated radiation - 80cGy with chemotherapy
Radiation: Low dose fractionated radiation - 80cGy with chemotherapy
Chemotherapy + 80 cGy of RT

Active Comparator: Chemotherapy without Radiation
Chemotherapy only
Drug: Docetaxel and Carboplatin AUC 6
Docetaxel 75 mg/m2 and Carboplatin AUC 6 without Radiation




Primary Outcome Measures :
  1. Complete Response Rate [ Time Frame: Up to 50 days ]
    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.


Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: Up to 50 days ]
    To assess overall response rate of patients to 2 cycles of induction Docetaxel and Carboplatin with or without LDFRT

  2. Number of Serious and Non-Serious Adverse Events [ Time Frame: Up to 50 days ]
  3. Quality of Life [ Time Frame: Up to 50 days ]
  4. 3-year overall survival [ Time Frame: Year 3 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02126969


Contacts
Contact: Cynthia Leedham, CRA 859-257-3379 cynthia.leedham@uky.edu
Contact: Jeri Reynolds, RN 859-257-3379 jeri.reynolds@uky.edu

Locations
United States, Kentucky
University of Kentucky, Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Susanne M Arnold, MD    859-257-3379    susanne.arnold@uky.edu   
Principal Investigator: Susanne M Arnold, MD         
Sponsors and Collaborators
University of Kentucky
Investigators
Principal Investigator: Susanne M Arnold, MD Lucille P. Markey Cancer Center at University of Kentucky

Responsible Party: Susanne Arnold, Principal Investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT02126969     History of Changes
Other Study ID Numbers: MCC-13-HN-24
First Posted: April 30, 2014    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017

Keywords provided by Susanne Arnold, University of Kentucky:
Cancer
Low dose radiation

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Docetaxel
Carboplatin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action