Phase II Randomized Study of Hypofractionated Versus Conventional Radiotherapy

Conditions

• Laryngeal Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• LT-SABR — RADIATION
  42.5 Gy in 5 fractions Low-risk: twice/week Moderate-risk: weekly
• IMRT — RADIATION
  63 Gy in 28 fractions (T1) 65.25 Gy in 29 fractions (T2)

Study Details

To compare the acute tolerance of highly conformal hypofractionated versus conventional radiotherapy.

Key Dates

Start date

Mar 14, 2024

Status verified

Nov 2025

Primary completion

Nov 1, 2028

Completion

Mar 14, 2029

Study Design

Enrollment

67 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Highly conformal hypofractionated radiotherapy
  LT-SABR 42.5 Gy in 5 fractions Low-risk: twice/week Moderate-risk: weekly
• Experimental: Conventional radiotherapy
  Conventional Radiotherapy 63 Gy in 28 fractions (T1) 65.25 Gy in 29 fractions (T2)

Primary Outcome Measure

To compare the acute toxicity outcomes between patients treated with highly-conformal hypofractionated radiotherapy and conventional radiotherapy. [ Time Frame: 3 months following treatment ]

Central Contacts

• David J Sher, MD,MPH
  214-645-2465
  [email protected]
• Sarah Neufeld
  214-645-8525
  [email protected]

Locations (1)

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