High-Dose or Standard-Dose Radiation Therapy and Chemotherapy With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel, carboplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether high-dose radiation therapy is more effective than standard-dose radiation therapy when given together with combination chemotherapy with or without cetuximab in treating patients with non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying high-dose or standard-dose radiation therapy given together with chemotherapy with or without cetuximab to see how well they work in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery.

Conditions

• Lung Cancer
• Radiation Toxicity

Interventions

BIOLOGICAL

Cetuximab

Loading dose: 400 mg/m2, IV, one week prior to start of radiation therapy (RT). Then, beginning day 1 of RT, 250 mg/m2, IV, weekly; for 60 Gy arm for 15 weeks, for 74 Gy arm for 16 weeks.

DRUG

Carboplatin

Concurrent: AUC=2, IV, days 1, 8, 14, 22, 29, and 36 of radiation therapy; for 74 Gy arms, on day 43 as well. Consolidation, 3 weeks after completion of RT, AUC=6, IV, days 1 and 22.

DRUG

Paclitaxel

Concurrent: 45 mg/m2, IV, days 1, 8, 14, 22, 29, and 36 of radiation therapy (RT); for 74 Gy arms, on day 43 as well. Consolidation, 3 weeks after completion of RT, 200 mg/m2, IV, days 1 and 22.

RADIATION

60 Gy RT

Radiation therapy (RT) in once-daily, 2 Gy fractions, given in 30 fractions over the course of 6 weeks.

RADIATION

74 Gy RT

Radiation therapy (RT) in once-daily, 2 Gy fractions, given in 37 fractions over the course of 7.5 weeks.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• North Central Cancer Treatment Group

  collaborator NETWORK

• Cancer and Leukemia Group B

  collaborator NETWORK

• NRG Oncology

  collaborator OTHER

• Radiation Therapy Oncology Group

  lead NETWORK

Principal Investigators

• Jeffrey Bradley, MD · Mallinckrodt Institute of Radiology at Washington University Medical Center

• Hak Choy, MD · Simmons Cancer Center

• Gregory A. Masters, MD · CCOP - Christiana Care Health Services

• Steven E. Schild, MD · Mayo Clinic

• Alex A. Adjei, MD, PhD · Roswell Park Cancer Institute

• Jeffrey A. Bogart, MD · State University of New York - Upstate Medical University

• Arthur William Blackstock, MD · Wake Forest University Health Sciences

• Mark A. Socinski, MD · UNC Lineberger Comprehensive Cancer Center

• George Blumenschein, MD · M.D. Anderson Cancer Center

• Ritsuko Komaki, MD · M.D. Anderson Cancer Center

• Jeff Sloan, PhD, HSR · Mayo Clinic

• Mark Dobelbower, MD PhD · University of Alabama Medical Center

• Tien Hoang, MD · University of Wisconsin, Madison

• Ken Forster, PhD · H. Lee Moffitt Cancer Center

• Benjamin Movsas, MD · Henry Ford Hospital

• Joe Y. Chang, MD PhD · M.D. Anderson Cancer Center

• Joseph O. Deasy, PhD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-11-30

Primary Completion

2013-06-30

Completion

2022-05-20

Countries

• United States
• Canada

Study Locations