Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery
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|ClinicalTrials.gov Identifier: NCT00004253|
Recruitment Status : Unknown
Verified November 2002 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : July 23, 2003
Last Update Posted : December 18, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Specialized radiation therapy delivers a high dose of radiation directly to the tumor which may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and specialized high-dose radiation therapy in treating patients who have stage II or stage III non-small cell lung cancer that cannot be removed by surgery.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: carboplatin Drug: paclitaxel Radiation: radiation therapy||Phase 2|
- Determine the probability of overall survival and local control in patients with favorable prognosis, unresectable stage II-IIIA/B non-small cell lung cancer receiving paclitaxel and carboplatin plus 3-D conformal hyperfractionation radiotherapy (3D-CHRT).
- Determine the incidence and severity of nonhematologic toxicity, specifically esophagitis and pneumonitis, during 3D-CHRT and chemotherapy with paclitaxel and carboplatin in these patients.
- Correlate complication rate with radiation based on the effective dose to determine safe treatment guidelines.
- Determine the feasibility of patient-specific dose escalation using this regimen in these patients.
- Determine the quality of life and symptom distress in these patients on this regimen.
OUTLINE: This is a dose-escalation study of 3-D conformal hyperfractionated radiotherapy (3D-CHRT).
Patients receive paclitaxel IV over 1 hour followed immediately by carboplatin IV over 30 minutes weekly for 6-8 weeks. Patients undergo 3D-CHRT twice daily five days a week for 6-8 weeks.
Cohorts of patients receive escalating doses of 3D-CHRT in 4 dose levels.
Quality of life is assessed prior to study, weekly during chemotherapy and radiotherapy, and at 3 and 6 months.
Patients are followed at 6 weeks, every 3 months for 1 year, every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 26-72 patients will be accrued for this study within 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase II Study of 3-Dimensional Conformal Hyperfractionation Radiation Therapy (3D-CHRT) With Dose Escalation and Amifostine Mucosal Protection for Patients With Favorable Prognosis Inoperable Stage II-IIIA/B Non-Small Cell Lung Cancer (NSCLC) Receiving Paclitaxel and Carboplatin|
|Study Start Date :||March 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004253
|United States, Florida|
|Sylvester Cancer Center, University of Miami|
|Miami, Florida, United States, 33136|
|Baptist Hospital of Miami|
|Miami, Florida, United States, 33176-2197|
|Study Chair:||Andre A. Abitbol, MD||Baptist Health South Florida|