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Chemoradiotherapy With Elective Low Dose Nodal Radiation for Locally Advanced Head and Neck Cancer

NCT01372111 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2015-12-09

No results posted yet for this study

Summary

Concurrent chemotherapy and radiation therapy (chemoRT) has become the standard of care for treatment of many patients with advanced head and neck squamous cell carcinoma (HNSCC), though many clinical questions remain. Prior experience has revealed locoregional control (LRC), disease free survival (DFS) and overall survival (OS) at 3 years exceeding 80% after treatment with the use of hyperfractionated intensity modulated radiation therapy (IMRT) and concurrent weekly cisplatin chemotherapy for patients with locally advanced HNSCC. This multi-institutional phase II ZCC00204 trial resulted in an acceptable quality of life (QOL) and toxicity profile. The current trial is an attempt to maintain high LRC, while further minimizing both acute and chronic toxicities, and maximizing QOL.

Conditions

Interventions

DRUG

Cisplatin

Cisplatin 35 mg/m2 IV weekly during weeks 1 through 6 of IMRT.

RADIATION

Elective Nodal Irradiation (ENI)

Low risk planning target volume (PTV) of 36 Gy at 2 Gy per fraction daily to bilateral, uninvolved neck nodal regions at risk for harboring microscopic cancer. High risk PTV will receive 70 Gy.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • New Hanover Regional Medical Center

    collaborator OTHER

  • Coastal Carolina Radiation Oncology

    lead OTHER

Principal Investigators

  • Patrick D. Maguire, M.D. · Coastal Carolina Radiation Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2016-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01372111 on ClinicalTrials.gov