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

NCT03388931 | Withdrawn Phase 4 DMC FDA Drug

• 2 other identifiers: IRB201702707OCR17025
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Squamous Cell Carcinoma

Keywords

Radiotherapy Dose Escalation

Outcome Measures

Primary Outcomes (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.

  Patients will receive an increased dose of radiation therapy

  Up to 2 years

Secondary Outcomes (3)

• Patient reported quality of life

  Up to 2 years

• Psychosocial function

  Up to 2 years

• Swallowing ability.

  Up to 2 years

Study Arms (1)

Study group

EXPERIMENTAL

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; Combination Product: Chemotherapy

Interventions

Radiation Therapy RADIATION

Increased radiation therapy dose

Study group

Chemotherapy COMBINATION_PRODUCT

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

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.)

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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Interventions

Radiotherapy; Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Robert J Amdur, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: January 3, 2018
• Study Start: February 4, 2019
• Primary Completion: May 6, 2019
• Study Completion: May 6, 2019
• Last Updated: May 13, 2019

Record last verified: 2019-05

Locations

US (1)