A Study of Radiation Therapy After Surgery in People With Oral Tongue Squamous Cell Carcinoma

Conditions

• Oral Tongue Squamous Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Photon intensity modulated radiation therapy (IMRT) — RADIATION
  Patients will receive bilateral cervical nodal irradiation with the primary post operative site excluded (30 fractions).
• Life questionnaire's — OTHER
  EORTC QLQ C30/HN 35 and MDADI

Study Details

This study will test whether limiting standard photon intensity modulated radiation therapy (IMRT) to exclude the oral tongue surgical site can decrease the risk of side effects caused by oral radiation. The researchers will also find out if this approach affects the rate of disease coming back after treatment (recurrence), and will measure participants' quality of life by having them complete questionnaires.

Key Dates

Start date

Jun 27, 2024

Status verified

May 2026

Primary completion

Jun 30, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

24 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Radiation Therapy
  These patients will then receive bilateral cervical nodal irradiation with the primary post operative site excluded (30 fractions). They will be monitored for both physician reported toxicities.

Primary Outcome Measure

Rate of Acute Grade ≥3 Oral Mucositis [ Time Frame: within 120 days of radiation completion ]

Central Contacts

• Sean McBride, MD, PhD
  646-608-2450
  [email protected]
• Nancy Lee, MD
  212-639-3341

Locations (7)

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