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

Alternate Title

Phase III Randomized Study of Hospitalization Rates of Patients With Non-Small Cell Lung Cancer Treated With Gemcitabine and Cisplatin Versus Gemcitabine and Carboplatin

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	Other	CHNT-GEM-HOSP EU-20245, NCT00055965

Trial Description

Purpose:

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if one regimen will require patients to spend more time in the hospital than the other regimen for treatment of chemotherapy-related side effects.

Randomized phase III trial to compare the hospitalization rates of patients who are receiving gemcitabine combined with cisplatin with that of patients receiving gemcitabine combined with carboplatin for unresectable stage III or stage IV non-small cell lung cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No previous chemotherapy or radiation therapy
• 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 to one of two groups. Patients in group one will receive a 30-minute infusion of gemcitabine and a 1- to 2-hour infusion of cisplatin on days 1 and 8. Patients in group two will receive gemcitabine as in group one and a 30- to 60-minute infusion of carboplatin on day 1. Treatment in both groups may be repeated every 3 weeks for up to four courses. Patients will be evaluated every 2 months for 6 months and every 3-4 months 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

Christie Hospital

Nick Thatcher, PhD, FRCP, Protocol chair		Ph: 44-845-226-3000 Email: nick.thatcher@christie.nhs.uk

Registry Information
Official Title		A Pragmatic, Randomised Study To Compare The Hospitalisation Rates Of Two Platinum-Based Outpatient Regimens (Gemcitabine/Cisplatin vs. Gemcitabine/Carboplatin) In Non-Small Cell Lung Cancer (NSCLC)
Registered in ClinicalTrials.gov		NCT00055965
Date Submitted to PDQ		2003-01-28
Information Last Verified		2009-01-23

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