Celecoxib or Observation After Radiation Therapy and Chemotherapy in Treating Patients With Stage II or Stage III Non-Small Cell Lung Cancer
Recruitment status was Active, not recruiting
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.
Procedure: adjuvant therapy
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Randomized Study Evaluting the Effect of Celecoxib as Maintenance Treatment of Stage IIIb Non-Small Cell Lung Cancer That Reponded or is Stable After Radiochemotherapy|
- Time to progression [ Designated as safety issue: No ]
- 2-year survival rate [ Designated as safety issue: No ]
- Quality of life [ Designated as safety issue: No ]
- Weight changes [ Designated as safety issue: No ]
- Objective response [ Designated as safety issue: No ]
- Tolerability [ Designated as safety issue: Yes ]
|Study Start Date:||May 2004|
- 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.
- 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.
|Bobigny, France, 93009|
|Centre Medical de Forcilles Hopital Prive|
|Ferroles Attilly, France, 77150|
|Clinique du Petit Colmouilins|
|Harfleur, France, 76700|
|Clinique Victor Hugo|
|Le Mans, France, F-72000|
|Polyclinique des Quatre Pavillons|
|Lormont, France, 33310|
|Centre de Radiotherapie et Oncologie Saint-Faron|
|Mareuil Les Meaux, France, 77100|
|American Hospital of Paris|
|Neuilly Sur Seine, France, F-92202|
|Clinique De Valdegour|
|Nimes, France, 30900|
|Paris, France, 75970|
|Paris, France, 75475|
|Clinique les Bleuets|
|Reims, France, 51100|
|Polyclinique De Courlancy|
|Reims, France, F-51100|
|Clinique Armoricaine De Radiologie|
|Saint Brieuc, France, F-22015|
|Centre Hospitalier Sud-Reiunion|
|Saint Pierre, France, 97448|
|Clinique Sainte Clotilde|
|Sainte Clotilde, France, 97192|
|Study Chair:||Jean F. Morere, MD||Hopital Avicenne|