Lung Cancer Clinical Trial
Official title:
PhII Study of Concurrent Chemoradiotherapy With Weekly Docetaxel, Carboplatin and Radiation Therapy Followed by Consolidation Chemotherapy With Docetaxel and Carboplatin for Locally Advanced Inoperable Non-small Cell Lung Cancer (NSCLC)
RATIONALE: Because of its success in advanced NSCLC both as a single agent and in
combination with other chemotherapeutics, it is reasonable to investigate the efficacy and
toxicity of docetaxel as a multimodality regimen in this patient population. Docetaxel at a
dose of 20 mg/m2 appears to be a well-tolerated "weekly" dose when combined with either
cisplatin 25 mg/m2 20-22 or carboplatin area under the curve (AUC) 2 23-25 concomitant with
radiation therapy.
PURPOSE: To explore the potential benefits of the radiosensitizing effects of weekly
docetaxel/carboplatin/radio therapy concurrent therapy followed full dose systemic
docetaxel/carboplatin consolidation therapy on overall response rate, survival,
progression-free survival, safety and toxicity in patients with locally advanced NSCLC.
OBJECTIVES:
Primary
- To determine the overall survival (0S) for advanced NSCLC patients receiving concurrent
chemoradiotherapy with weekly docetaxel, carboplatin and radiation therapy followed by
two cycles of consolidation chemotherapy with docetaxel and carboplatin.
Secondary
- To determine the overall response rate in patients treated with this regimen.
- To determine the time to disease progression in patients treated with this regimen.
- To assess the safety and tolerability of this regimen in these patients.
OUTLINE:
- This is a Phase II, open label, multi-center study to determine the overall survival
rate for patients treated with concurrent chemoradiotherapy with weekly docetaxel,
carboplatin and radiation followed by two cycles of consolidation chemotherapy with
docetaxel and carboplatin. Eligible patients will receive concurrent therapy with
docetaxel (20 mg/m2) administered weekly for seven weeks as a 30-minute intra-venous
(IV) infusion followed by carboplatin (AUC 2) administered weekly for seven weeks as a
30-minute IV infusion. Concurrent radiation therapy will be administered at a dose of
1.8 Gy daily 5 days/week for 25 fractions followed by a dose of 2.0 Gy daily, 5
days/week for 9 fractions (total of 34 fractions). There will be a three-week rest
period following the end of the concurrent chemotherapy after which the consolidation
phase will begin. During this phase of the study, patients will be treated with
docetaxel (75 mg/m2) administered as a 1-hour IV infusion followed by carboplatin (AUC
6) administered as a 30-minute IV infusion. Patient will be treated every three weeks
for a total of two cycles.
;
Intervention Model: Single Group Assignment, 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 |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
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 |
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 |
NCT03575793 -
A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
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
|