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

Withdrawn before enrolling · Phase 4

Conditions studied: Advanced Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT03388931

Run by

University of Florida

People needed

0

Starts

2019-02-04

Expected to finish

2019-05-06

Last updated by the study team

2019-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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