Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Christie Hospital NHS Foundation Trust |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00022009 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Treatment plus supportive care may improve quality of life in patients undergoing cancer treatment.
PURPOSE: Randomized phase II/III trial to compare the effect of different gemcitabine regimens plus supportive care on quality of life in patients who have locally advanced or metastatic non-small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: gemcitabine hydrochloride |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | Phase I/II Randomized Trial Comparing Two Treatment Schedules Of Gemcitabine In Poor Prognosis Status Patients With Advanced Non-Small Cell Lung Cancer |
Study Start Date: | July 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline and then after each course of chemotherapy.
Patients are followed every 2 months for survival.
PROJECTED ACCRUAL: A total of 174 patients (87 per treatment arm) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United Kingdom, England | |
Christie Hospital N.H.S. Trust | |
Manchester, England, United Kingdom, M20 4BX |
Study Chair: | Nick Thatcher, PhD, FRCP | Christie Hospital NHS Foundation Trust |
Study ID Numbers: | CDR0000068683, CHNT-GEM, EU-20062 |
Study First Received: | August 10, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00022009 History of Changes |
Health Authority: | United States: Federal Government |
stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
Thoracic Neoplasms Antimetabolites Immunologic Factors Antiviral Agents Immunosuppressive Agents Carcinoma Radiation-Sensitizing Agents |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Gemcitabine Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Gemcitabine |
Respiratory Tract Neoplasms Neoplasms by Histologic Type Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Radiation-Sensitizing Agents Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |