Phase II Trial Evaluating Elimination of Radiation Therapy

The Washington University

Status and phase: Active, not recruiting; Phase 2

Conditions: Cancer of the Larynx

Treatments: Radiation: Intensity modulated radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00593840

07-0142 / 201106342

Details and patient eligibility

About

The purpose of this study is to determine if reducing or eliminating radiation treatment to one or both sides of the neck where there is no evidence of cancer can help spare the side effects of radiation treatment for head and neck cancer. In this study, the investigators plan to reduce the amount of radiation treatment received to healthy tissue

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with pathologically proven tumors of the oral cavity, oropharynx, larynx, or hypopharynx .

• Treated with surgical resection with one (or both) side(s) of the neck pathologically N0.

• Indication for radiation therapy at the primary site or neck consisting of any of the below characteristics:

  • Close margin (<= 0.5 cm)
  • Positive margin
  • Perineural invasion
  • Lymphovascular space invasion
  • Metastatic disease in more than one lymph node
  • Metastatic disease in more than one lymph node group
  • Extracapsular extension in any lymph node
  • Constellation of factors considered to be at risk based on the multi-disciplinary tumor board discussion.

• Age >= 18.

• Patients must sign study specific, Institutional Review Board (IRB)-approved consent form.

Exclusion criteria

• Previous head and neck cancer other than non melanoma skin cancer.
• Previous head and neck surgery.
• Female patients who are pregnant or nursing.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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74 participants in 1 patient group

Intensity modulated radiation therapy (IMRT)

Experimental group

Description:

-This study provides guidelines for volume to be contoured during IMRT based on tumor site and stage of tumor site. The clinical tumor volume (CTV)1 will be treated to 66 Cy in 33 fractions or 60 Gy in 30 fractions. The CTV2 will be treated to 54 Gy in 33 fractions or 52 Gy in 30 fractions. The CTV3 will be modified based on tumor site and stage of tumor site in order to reduce volume.

Treatment:

Radiation: Intensity modulated radiation therapy