Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023673
Status:
COMPLETED
Last Update Posted:
2017-12-22
First Post:
2001-09-13
Brief Title:
Radiation Therapy Combined With Paclitaxel and Carboplatin in Treating Patients With Stage III Non-Small Cell Lung Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase III Dose Intensification Study Using Three Dimensional Conformal Radiation Therapy And Concurrent Chemotherapy For Patients With Inoperable Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
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 Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy such as paclitaxel and carboplatin work in different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug and giving them with specialized radiation therapy may kill more tumor cells
PURPOSE This phase III trial is studying the effectiveness of radiation therapy combined with paclitaxel and carboplatin in treating patients who have stage III non-small cell lung cancer
PURPOSE This phase III trial is studying the effectiveness of radiation therapy combined with paclitaxel and carboplatin in treating patients who have stage III non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of 3-dimensional conformal radiotherapy when administered concurrently with paclitaxel and carboplatin in patients with inoperable stage IIIA or IIIB non-small cell lung cancer Phase I Closed to accrual as of 011304
Determine the 12-month survival rate in patients treated with this regimen Phase II Closed to accrual as of 112707
Determine the toxicity of this regimen in these patients
Determine the partial organ tolerance doses for the lung and esophagus in patients treated with this regimen
Determine the complete response rate in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of 3-dimensional conformal radiotherapy
Phase I closed to accrual as of 011304 Patients undergo 3-dimensional conformal radiotherapy once daily five days a week for 7-8 weeks Patients also receive concurrent chemotherapy comprising paclitaxel IV over 1 hour followed by carboplatin IV over 30 minutes on days 1 8 15 22 29 36 and 43
Cohorts of 7-9 patients receive de-escalating doses of 3-dimensional conformal radiotherapy until the maximum tolerated dose MTD is determined when given in combination with chemotherapy The MTD is defined as the highest dose at which no more than 1 patient experiences dose-limiting toxicity
Phase II Additional patients are accrued and treated as above at the MTD At least 3 weeks after completing radiotherapy patients may receive additional chemotherapy comprising paclitaxel IV over 3 hours once and carboplatin IV over 30 minutes once Treatment with paclitaxel and carboplatin may repeat every 3 weeks for up to 2 courses
Patients are followed every 3 months for 1 year every 4 months for 1 year every 6 months for 3-5 years and then annually thereafter
PROJECTED ACCRUAL A maximum of 73 patients up to 27 for phase I closed to accrual as of 102804 and 46 for phase II will be accrued for this study within 1-15 years
Determine the maximum tolerated dose of 3-dimensional conformal radiotherapy when administered concurrently with paclitaxel and carboplatin in patients with inoperable stage IIIA or IIIB non-small cell lung cancer Phase I Closed to accrual as of 011304
Determine the 12-month survival rate in patients treated with this regimen Phase II Closed to accrual as of 112707
Determine the toxicity of this regimen in these patients
Determine the partial organ tolerance doses for the lung and esophagus in patients treated with this regimen
Determine the complete response rate in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of 3-dimensional conformal radiotherapy
Phase I closed to accrual as of 011304 Patients undergo 3-dimensional conformal radiotherapy once daily five days a week for 7-8 weeks Patients also receive concurrent chemotherapy comprising paclitaxel IV over 1 hour followed by carboplatin IV over 30 minutes on days 1 8 15 22 29 36 and 43
Cohorts of 7-9 patients receive de-escalating doses of 3-dimensional conformal radiotherapy until the maximum tolerated dose MTD is determined when given in combination with chemotherapy The MTD is defined as the highest dose at which no more than 1 patient experiences dose-limiting toxicity
Phase II Additional patients are accrued and treated as above at the MTD At least 3 weeks after completing radiotherapy patients may receive additional chemotherapy comprising paclitaxel IV over 3 hours once and carboplatin IV over 30 minutes once Treatment with paclitaxel and carboplatin may repeat every 3 weeks for up to 2 courses
Patients are followed every 3 months for 1 year every 4 months for 1 year every 6 months for 3-5 years and then annually thereafter
PROJECTED ACCRUAL A maximum of 73 patients up to 27 for phase I closed to accrual as of 102804 and 46 for phase II will be accrued for this study within 1-15 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-2012-02401 | REGISTRY | CTRP Clinical Trials Reporting System | None |
| CDR0000068850 | REGISTRY | None | None |