Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of High- Versus Standard-Dose Conformal Radiotherapy With Concurrent and Consolidation Chemotherapy Comprising Carboplatin and Paclitaxel With Versus Without Cetuximab in Patients With Newly Diagnosed, Unresectable Stage IIIA or IIIB Non-Small Cell Lung Cancer (Arms II and IV closed to accrual effective 6/17/11)

Basic Trial Information

Special Category: CTSU trial

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No distant metastases or Pancoast tumors
• Measurable disease
• At least 3 weeks since chest surgery
• No previous chemotherapy for non-small cell lung cancer
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed) to one of four treatment groups.

Patients in group one will undergo low-dose radiation therapy 5 days a week for 6 weeks. They will also receive a 1-hour infusion of paclitaxel and an infusion of carboplatin once a week in weeks 1-6. Patients will receive additional paclitaxel and carboplatin in weeks 10 and 13.

Patients in group two will undergo high-dose radiation therapy 5 days a week for 7½ weeks. They will also receive a 1-hour infusion of paclitaxel and an infusion of carboplatin once a week in weeks 1-7. Patients will receive additional paclitaxel and carboplatin in weeks 11 and 14. (closed to accrual effective 6/17/11)

Patients in group three will undergo standard-dose radiation therapy 5 days a week for 6 weeks. They will also receive a 1-hour infusion of cetuximab, paclitaxel, and carboplatin once a week in weeks 1-6. Patients will receive additional cetuximab, paclitaxel, and carboplatin in weeks 11 and 14.

Patients in group four will undergo high-dose radiation therapy 5 days a week for 7½ weeks. They will also receive a 1-hour infusion of cetuximab, paclitaxel, and carboplatin once a week in weeks 1-7. Patients will receive additional cetuximab, paclitaxel, and carboplatin in weeks 12 and 15. (closed to accrual effective 6/17/11)

Patients may undergo tumor tissue, blood, and urine collection periodically for laboratory studies.

Quality of life may be assessed at the beginning of the study and periodically during the study. After finishing treatment, patients will be evaluated periodically for 5 years and once a year thereafter.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Jeffrey Bradley, MD, Principal investigator		Ph: 314-362-8525
Hak Choy, MD, Protocol co-chair		Ph: 214-645-7600; 866-460-4673 Email: Hak.Choy@UTSouthwestern.edu
Gregory Masters, MD, Protocol co-chair		Ph: 302-366-1200

North Central Cancer Treatment Group

Steven Schild, MD, Protocol chair		Ph: 480-301- Email: sschild@mayo.edu
Alex Adjei, MD, PhD, Protocol co-chair		Ph: 507-538-0268; 800-685-6825 Email: alex.adjei@roswellpark.org

Cancer and Leukemia Group B

Jeffrey Bogart, MD, Protocol chair		Ph: 315-464-5276; 877-464-8668 Email: bogartj@upstate.edu
Arthur William Blackstock, MD, Protocol co-chair		Ph: 336-713-6501; 800-446-2255
Mark Socinski, MD, Protocol co-chair		Ph: 919-966-4431 Email: socinski@med.unc.edu

Registry Information
Official Title		A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin/Paclitaxel +/- Cetuximab (IND #103444) in Patients with Stage IIIA/IIIB Non-Small Cell Lung Cancer
Trial Start Date		2007-11-27
Trial Completion Date		2014-01-27 (estimated)
Registered in ClinicalTrials.gov		NCT00533949
Date Submitted to PDQ		2007-08-22
Information Last Verified		2011-11-23
NCI Grant/Contract Number		CA21661

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