Phase I Study of IMRT and Molecular-Image Guided Adaptive Radiation Therapy for Advanced HNSCC

Summary

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. CT and PET scans and treatment-planning systems may help in planning radiation therapy. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cisplatin may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of intensity-modulated image guided adaptive radiation therapy when given together with cisplatin in treating patients with locally advanced head and neck squamous cell cancer

Conditions

• Salivary Gland Squamous Cell Carcinoma
• Stage II Salivary Gland Cancer
• Stage II Squamous Cell Carcinoma of the Hypopharynx
• Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity
• Stage II Squamous Cell Carcinoma of the Oropharynx
• Stage II Verrucous Carcinoma of the Oral Cavity
• Stage III Salivary Gland Cancer
• Stage III Squamous Cell Carcinoma of the Hypopharynx
• Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
• Stage III Squamous Cell Carcinoma of the Oropharynx
• Stage III Verrucous Carcinoma of the Oral Cavity
• Stage IV Salivary Gland Cancer
• Stage IV Squamous Cell Carcinoma of the Hypopharynx
• Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
• Stage IV Squamous Cell Carcinoma of the Oropharynx
• Stage IV Verrucous Carcinoma of the Oral Cavity

Interventions

RADIATION

intensity-modulated radiation therapy

Undergo intensity-modulated image-guided adaptive radiotherapy

DRUG

cisplatin

Given IV

RADIATION

image-guided adaptive radiation therapy

Undergo intensity-modulated image-guided adaptive radiotherapy

OTHER

3'-deoxy-3'-[18F]fluorothymidine

Undergo FLT-PET scans for IMRT/IGART

PROCEDURE

positron emission tomography/computed tomography

Undergo FDG/FLT-PET scans for IMRT/IGARTT

RADIATION

fludeoxyglucose F 18

Undergo FDG-PET scans for IMRT/IGART

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Virginia Commonwealth University

  lead OTHER

Principal Investigators

• Shiyu Song · Virginia Commonwealth University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-07-31

Primary Completion

2016-03-31

Completion

2016-09-30

Countries

• United States

Study Locations