Celecoxib or Observation After Radiation Therapy and Chemotherapy in Treating Patients With Stage II or Stage III Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00274898
- Lead Sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving celecoxib after radiation therapy and chemotherapy may kill any tumor cells that remain after radiation therapy and chemotherapy. Sometimes, after radiation therapy and chemotherapy, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient.
PURPOSE: This randomized phase II trial is studying celecoxib to see how well it works compared to observation in treating patients who have undergone radiation therapy and chemotherapy for stage II or stage III non-small cell lung cancer.
- Detailed Description
OBJECTIVES:
Primary
* Compare the time to progression in patients with stage II-IIIB non-small cell lung cancer treated with celecoxib vs observation after treatment with chemoradiotherapy.
Secondary
* Compare the 2-year survival rate of patients treated with these regimens.
* Compare the quality of life of patients treated with these regimens.
* Compare weight changes and objective response in patients treated with these regimens.
* Compare tolerability of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, ECOG performance status (0-1 vs 2), and total dose of radiotherapy (65 Gy vs 60 Gy).
All patients undergo radiotherapy 5 days a week for 7.5 weeks. Patients also receive docetaxel IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Three weeks after the completion of radiotherapy, patients receive docetaxel alone IV over 30 minutes on days 1 and 22. Three weeks later, patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients are observed every 3 months for 1 year and then every 6 months for 1 year.
* Arm II: Patients receive oral celecoxib twice daily for up to 2 years in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every 3 months for 1 year, and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to progression
- Secondary Outcome Measures
Name Time Method 2-year survival rate Quality of life Weight changes Objective response Tolerability
Trial Locations
- Locations (15)
Centre Hospitalier Sud-Reiunion
🇫🇷Saint Pierre, France
Hopital Tenon
🇫🇷Paris, France
Hopital Avicenne
🇫🇷Bobigny, France
Clinique du Petit Colmouilins
🇫🇷Harfleur, France
Centre Medical de Forcilles Hopital Prive
🇫🇷Ferroles Attilly, France
Polyclinique des Quatre Pavillons
🇫🇷Lormont, France
Centre de Radiotherapie et Oncologie Saint-Faron
🇫🇷Mareuil Les Meaux, France
Clinique Victor Hugo
🇫🇷Le Mans, France
American Hospital of Paris
🇫🇷Neuilly Sur Seine, France
Clinique De Valdegour
🇫🇷Nimes, France
Hopital Saint-Louis
🇫🇷Paris, France
Clinique les Bleuets
🇫🇷Reims, France
Polyclinique De Courlancy
🇫🇷Reims, France
Clinique Armoricaine De Radiologie
🇫🇷Saint Brieuc, France
Clinique Sainte Clotilde
🇫🇷Sainte Clotilde, France