Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032032
Status:
COMPLETED
Last Update Posted:
2016-12-01
First Post:
2002-03-08
Brief Title:
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase III Study Of Concurrent Chemotherapy And Escalating Doses Of Radiotherapy RT For Unresectable Non-Small Cell Lung Cancer NSCLC Using A New RT Paradigm
Status:
COMPLETED
Status Verified Date:
2016-11
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 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 chemotherapy and radiation therapy may kill more tumor cells
PURPOSE This phase III trial is studying the side effects and best dose of radiation therapy when given with combination chemotherapy and to see how well they work in treating patients with non-small cell lung cancer that cannot be surgically removed
PURPOSE This phase III trial is studying the side effects and best dose of radiation therapy when given with combination chemotherapy and to see how well they work in treating patients with non-small cell lung cancer that cannot be surgically removed
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of radiotherapy in combination with carboplatin and paclitaxel in patients with unresectable non-small cell lung cancer
Determine the 2-year survival of patients treated with this regimen
Determine the progression-free local control rate in patients treated this regimen
Determine the tolerability of this regimen in these patients
Assess the quality of life of patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of radiotherapy
Patients undergo radiotherapy once daily 5 days a week for 7 weeks and 2 days a total of 37 fractions Patients concurrently receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes once weekly for 7 weeks Treatment continues in the absence of disease progression or unacceptable toxicity
NOTE No prophylactic nodal radiotherapy is administered
Cohorts of 3-6 patients receive escalating doses of radiotherapy until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined 12 additional patients are treated at that dose level in the phase II portion of the study
Beginning 3 weeks after completion of radiotherapy patients receive paclitaxel and carboplatin as above Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline once during the last week of radiotherapy and then every 3 months for 2 years
Patients are followed at 3 weeks every 3 months for 21 months and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 90 patients will be accrued for this study
Determine the maximum tolerated dose of radiotherapy in combination with carboplatin and paclitaxel in patients with unresectable non-small cell lung cancer
Determine the 2-year survival of patients treated with this regimen
Determine the progression-free local control rate in patients treated this regimen
Determine the tolerability of this regimen in these patients
Assess the quality of life of patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of radiotherapy
Patients undergo radiotherapy once daily 5 days a week for 7 weeks and 2 days a total of 37 fractions Patients concurrently receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes once weekly for 7 weeks Treatment continues in the absence of disease progression or unacceptable toxicity
NOTE No prophylactic nodal radiotherapy is administered
Cohorts of 3-6 patients receive escalating doses of radiotherapy until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined 12 additional patients are treated at that dose level in the phase II portion of the study
Beginning 3 weeks after completion of radiotherapy patients receive paclitaxel and carboplatin as above Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline once during the last week of radiotherapy and then every 3 months for 2 years
Patients are followed at 3 weeks every 3 months for 21 months and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 90 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000069250 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02458 | REGISTRY | None | None |