Lung Cancer Clinical Trial
Official title:
Multimodality Therapy for Stages II and III Non-Small Cell Lung Cancer: Surgical Resection Followed by Sequential Administration of Gemcitabine Plus Cisplatin Chemotherapy and Radiation Therapy
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving more than one drug (combination chemotherapy) together with radiation
therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well surgery followed by gemcitabine,
cisplatin, and radiation therapy works in treating patients with stage II or stage III
non-small cell lung cancer.
OBJECTIVES:
- To assess overall survival and progression-free survival of patients with stage II-IIIB
non-small cell lung cancer undergoing surgical resection, followed by adjuvant
chemotherapy comprising gemcitabine and cisplatin, and radiotherapy.
- To assess the toxicities of this regimen in these patients.
- To evaluate the mRNA expression of enzymes (i.e., excision repair cross complementing
protein, ribonucleotide reductase, and cytidine/deoxycytidine deaminase and kinase),
which may be important in regulating the cytotoxicity of gemcitabine and cisplatin in
patient tumors.
- To correlate mRNA levels with progression-free survival of patients treated with this
regimen.
- To assess BCL2, P53, and HER2-neu expression by IHC and correlation with
progression-free survival.
OUTLINE: Patients undergo surgical resection of their tumor and mediastinal lymph node
dissection. Patients with complete surgical eradication of their disease or pathologic
evidence of microscopic residual disease proceed to adjuvant chemotherapy.
Within approximately 60 days after surgical resection, patients receive adjuvant
chemotherapy comprising gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over
1 hour on day 8. Treatment repeats every 21 days for up to 3 courses in the absence of
disease progression or unacceptable toxicity.
Beginning 130-144 days after surgery, patients undergo radiotherapy once daily, five days a
week, for approximately 6 weeks.
Tumor tissue specimens are obtained at the time of surgical resection for pharmacodynamic
and biomarker correlative studies. Specimens are examined by reverse
transcriptase-polymerase chain reaction to measure mRNA expression of target oncogenes
(i.e., DNA repair gene ERCC-1 and M2 subunit of the DNA repair gene ribonucleotide
reductase) and enzymes (i.e., cytidine/deoxycytidine deaminase and kinase). Resected
specimens are also assessed by IHC for the expression of BCL2, P53, and HER2-neu genes.
After completion of study therapy, patients are followed every 6 months for 5 years and
annually thereafter.
;
Endpoint Classification: Efficacy Study, 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 |
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
|