Chemotherapy Followed by Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Locally Advanced Head And Neck Cancer

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs such as gemcitabine and cisplatin may make tumor cells more sensitive to radiation therapy. Giving combination chemotherapy before surgery or radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving chemotherapy followed by surgery, chemotherapy, and radiation therapy works in treating patients with locally advanced head and neck cancer.

Conditions

• Head and Neck Cancer

Interventions

DRUG

cisplatin

DRUG

docetaxel

DRUG

fluorouracil

DRUG

gemcitabine hydrochloride

DRUG

leucovorin calcium

GENETIC

gene expression analysis

GENETIC

protein expression analysis

OTHER

laboratory biomarker analysis

PROCEDURE

adjuvant therapy

PROCEDURE

biopsy

PROCEDURE

conventional surgery

PROCEDURE

neoadjuvant therapy

PROCEDURE

quality-of-life assessment

RADIATION

radiation therapy

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• City of Hope Medical Center

  lead OTHER

Principal Investigators

• Stephen I. Shibata, MD · City of Hope Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

0 Years

Max Age

120 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2000-06-07

Primary Completion

2017-02-14

Completion

2024-07-02