Radiotherapy Dose Escalation in Locally Advanced Squamous Cell Carcinoma of the Larynx or Hypopharynx

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. Identifier: NCT03388931
Recruitment Status : Not yet recruiting
First Posted : January 3, 2018
Last Update Posted : January 14, 2019
Information provided by (Responsible Party):
University of Florida

Brief Summary:
This is a phase 2 single arm study of a novel schedule of hyperfractionated radiotherapy (RT) in combination with our standard chemotherapy program for patients with stage 3-4 squamous cell carcinoma of the larynx. The primary hypothesis of our study is that the study program will improve Laryngectomy-Free Survival compared to historical controls. The study is limited to patients who would be receiving primary RT-C as standard therapy off-study.

Condition or disease Intervention/treatment Phase
Advanced Squamous Cell Carcinoma Radiation: Radiation Therapy Other: Chemotherapy Not Applicable

Detailed Description:
The novel radiotherapy schedule that is the subject of this study is only slightly different from the program that has been used in the cooperative group trial RTOG 9003. The radiation therapy dose schedule in our study twice-daily alternating fractions over 30 treatment days. The Biologically Effective Dose (BED) of this schedule is about 11% higher than our standard schedule twice-a-day. During radiotherapy, patients will receive chemotherapy with our standard program of weekly.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiotherapy Dose Escalation in Locally Advanced Squamous Cell Carcinoma of the Larynx or Hypopharynx
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Study group
Increased dose of radiation therapy for locally advanced squamous cell carcinoma of the larynx or hypopharynx. Patients will also receive standard-of-care chemotherapy with the treatment regimen to be determined by the treating physicians.
Radiation: Radiation Therapy
Increased radiation therapy dose

Other: Chemotherapy
Standard-of-care chemotherapy with treatment regimen to be determined by the treating physician

Primary Outcome Measures :
  1. Whether radiation therapy dose escalation as used in our study will improve Laryngectomy-Free Survival compared to historical controls in patients with locally advanced squamous cell carcinoma of the larynx. [ Time Frame: Up to 2 years ]
    Patients will receive an increased dose of radiation therapy

Secondary Outcome Measures :
  1. Patient reported quality of life [ Time Frame: Up to 2 years ]
    The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients Likert scales 1-4,(1 = All, 2 = Little, 3 = a Bit, 4 = Very much)

  2. Psychosocial function [ Time Frame: Up to 2 years ]
    Voice Handicap Index (VHI) a 30-item questionnaire. Likert scale 0- 4, 0 = never and 4 Always) A change between two administrations of 18 points represents a significant shift in psychosocial function.

  3. Swallowing ability. [ Time Frame: Up to 2 years ]
    The MD Anderson Symptom Inventory (MDASI) is a multi-symptom patient-reported outcome (PRO) measure for clinical and research use. Use the MDASI to assess the severity of symptoms experienced by patients with cancer and the interference with daily living caused by these symptoms.MD Anderson Dysphagia Index (MDADI)

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

Inclusion Criteria:

  • At least 18 years of age (no upper age limit)
  • Biopsy proven squamous cell carcinoma of the glottis or supraglottic larynx or hypopharynx with the following T,N and M stages:
  • Glottic Larynx:

T3-4: Any primary tumor volume

  • Supraglottic Larynx:

T2: Primary tumor volume > 4.0cc T3-4: Any primary tumor volume

  • Hypopharynx:

T2: Primary tumor volume > 4.0cc T3-4: Any primary tumor volume

  • N-Stages (the same for all primary sites): All N-stages
  • M-Stages (the same for all primary sites): M0 or M1suitable for curative attempt with Stereotactic Body Radiation Therapy.
  • Radiologic evaluation of the chest within 12 weeks prior to treatment; at a minimum, chest x-ray is required. CT imaging of the chest or PET/CT is acceptable.
  • ECOG Performance Status 0-2
  • CBC/differential obtained within 8 weeks prior to treatment, with adequate bone marrow function defined as follows:
  • Platelets ≥ 100,000 cells/mm3
  • Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.)
  • Adequate renal and hepatic function within 4 weeks prior to treatment, defined as follows:
  • Serum creatinine < 2.0 mg/dl
  • Total bilirubin < 2 x the institutional ULN
  • AST or ALT < 3 x the institutional ULN.

    *Note that physician attestation of patient having no known history of liver disease can take the place of bilirubin and AST/ALT labs.

  • Negative pregnancy test within 2 weeks prior to treatment for women of childbearing potential
  • Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment.
  • Patients must be deemed able to comply with the treatment plan and follow-up schedule.
  • Patients must provide study specific informed consent prior to study entry

Exclusion Criteria:

  • Prior history of radiation therapy to the head and neck that would likely increase the risk of serious complications from the RT delivered on this protocol
  • Prior history of head and neck cancer with the exception of nonmelanoma skin cancer.
  • Currently taking Disease Modifying Rheumatoid Drugs (DMRDs)
  • Severe, active co-morbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
  • Transmural myocardial infarction within the last 6 months
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; Note, however, coagulation parameters are not required for entry into this protocol.
  • Pre-existing ≥ grade 2 neuropathy
  • Prior organ transplant
  • Systemic lupus
  • Psoriatic arthritis.
  • Known HIV positive. HIV positive patients are known to have worse clinical outcomes especially for local, regional, and distant cancer control. This poorer prognosis is thought to be secondary to a compromised immune system.

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 identifier (NCT number): NCT03388931

Contact: John M Lybarger, MPH 352-265-8851
Contact: Andrew Chadwick 352-265-0680

United States, Florida
University of Florida Not yet recruiting
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Principal Investigator: Robert J Amdur, MD University of Florida

Responsible Party: University of Florida Identifier: NCT03388931     History of Changes
Other Study ID Numbers: IRB201702707
OCR17025 ( Other Identifier: University of Florida )
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Radiotherapy Dose Escalation

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell