Lung Cancer Clinical Trial
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
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.
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.
;
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03918538 -
A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors
|
N/A | |
| Recruiting |
NCT05078918 -
Comprehensive Care Program for Their Return to Normal Life Among Lung Cancer Survivors
|
N/A | |
| Active, not recruiting |
NCT04548830 -
Safety of Lung Cryobiopsy in People With Cancer
|
Phase 2 | |
| Completed |
NCT04633850 -
Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
|
||
| Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
| Recruiting |
NCT05583916 -
Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery
|
N/A | |
| Completed |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
| Not yet recruiting |
NCT06376253 -
A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers
|
Phase 1 | |
| Recruiting |
NCT05898594 -
Lung Cancer Screening in High-risk Black Women
|
N/A | |
| Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
| Active, not recruiting |
NCT03575793 -
A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer
|
Phase 1/Phase 2 | |
| Terminated |
NCT01624090 -
Mithramycin for Lung, Esophagus, and Other Chest Cancers
|
Phase 2 | |
| Terminated |
NCT03275688 -
NanoSpectrometer Biomarker Discovery and Confirmation Study
|
||
| Not yet recruiting |
NCT04931420 -
Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels
|
Phase 2 | |
| Recruiting |
NCT06010862 -
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT06052449 -
Assessing Social Determinants of Health to Increase Cancer Screening
|
N/A | |
| Not yet recruiting |
NCT06017271 -
Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
|
||
| Recruiting |
NCT05787522 -
Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk
|