Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004253
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2000-01-28
Brief Title:
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
Sponsor:
Baptist Health South Florida
Organization:
National Cancer Institute NCI
Study Overview
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-IIIAB Non-Small Cell Lung Cancer NSCLC Receiving Paclitaxel and Carboplatin
Status:
UNKNOWN
Status Verified Date:
2002-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
OBJECTIVES
Determine the probability of overall survival and local control in patients with favorable prognosis unresectable stage II-IIIAB 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
Determine the probability of overall survival and local control in patients with favorable prognosis unresectable stage II-IIIAB 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V99-1582 | None | None | None |
| BHM-L1 | None | None | None |
| BHM-99-64 | None | None | None |