Cisplatin and Docetaxel With or Without Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Newly Diagnosed Stage III Non-Small Cell Lung Cancer

Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Cisplatin and docetaxel may make tumor cells more sensitive to radiation therapy. Giving more than one drug (combination chemotherapy) together with radiation therapy before surgery may shrink the tumor so it can be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving cisplatin and docetaxel together with radiation therapy is more effective than giving cisplatin together with docetaxel in treating non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying cisplatin, docetaxel, and radiation therapy to see how well they work compared to cisplatin and docetaxel in treating patients who are undergoing surgery for newly diagnosed stage III non-small cell lung cancer.

Conditions

• Lung Cancer

Interventions

BIOLOGICAL

filgrastim

Consolidation chemotherapy

BIOLOGICAL

pegfilgrastim

Consolidation chemotherapy

DRUG

cisplatin

DRUG

docetaxel

PROCEDURE

adjuvant therapy

PROCEDURE

conventional surgery

PROCEDURE

neoadjuvant therapy

RADIATION

radiation therapy

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• SWOG Cancer Research Network

  collaborator NETWORK

• Cancer and Leukemia Group B

  collaborator NETWORK

• Eastern Cooperative Oncology Group

  collaborator NETWORK

• North Central Cancer Treatment Group

  collaborator NETWORK

• Radiation Therapy Oncology Group

  lead NETWORK

Principal Investigators

• Maria Werner-Wasik, MD · Sidney Kimmel Cancer Center at Thomas Jefferson University

• Howard L. West, MD · Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

• Jeffrey Crawford, MD · Duke Cancer Institute

• Chandra P. Belani, MD · University of Pittsburgh

• James R. Jett, MD · Mayo Clinic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-04-30

Primary Completion

2009-02-28

Countries

• United States

Study Locations