A Phase 2 interventional study of carboplatin and paclitaxel in Lung Cancer, sponsored by Medstar Health Research Institute. Completed at 2 sites in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2020-08-19.
Sponsored by Medstar Health Research Institute · Phase 2, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining these treatments before surgery may kill more tumor cells in patients with non-small cell lung cancer.
PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with radiation therapy before surgery in treating patients who have stage IIB non-small cell lung cancer or stage IIIA non-small cell lung cancer.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes weekly for 5 weeks. Patients also undergo concurrent radiotherapy daily 5 days a week for 5 weeks in the absence of unacceptable toxicity. At approximately 4 weeks after completion of chemoradiotherapy, patients with stable or regressive disease undergo surgical resection. If disease is unresectable, patients receive an additional 2 weeks of radiotherapy.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 29-30 patients will be accrued for this study.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Medstar Health Research Institute is the lead sponsor of 160 studies on the registry; 32 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed bulky stage IIB or stage IIIA non-small cell lung cancer
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Concurrent Paclitaxel, Carboplatin, and External-Beam Radiation Followed by Surgical Resection in Locally Advanced Non-Small-Cell Lung Cancer
Drug: carboplatin · Drug: paclitaxel · Procedure: conventional surgery · Procedure: neoadjuvant therapy · Radiation: radiation therapy
Also known as: paraplatin
Also known as: taxol
Pathologic response rate
as measured by pathology of the resected specimen and chest x-ray at 3 and 5 years after completion of study treatment.
Time frame: 3-5 Years
Disease-free and overall survival at 3 and 5 years after completion of study treatment
Time frame: 3-5 Years
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Medstar Health Research Institute