Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003803
Status:
TERMINATED
Last Update Posted:
2012-07-18
First Post:
1999-11-01
Brief Title:
Chemotherapy Plus Radiation Therapy in Treating Patients With Stage I Stage II or Stage III Non-small Cell Lung Cancer That Cannot Be Surgically Removed
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A Randomized Phase III Study Comparing Induction Chemotherapy to Daily Low Dose Cisplatin Both Combined With High Dose Radiotherapy Using Concomitant Boost Technique in Patients With Inoperable Non-Small Cell Lung Cancer Stage I II and Low Volume Stage III
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
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 used high-energy x-rays to damage tumor cells It is not yet know whether chemotherapy followed by radiation therapy is more effective than chemotherapy given with radiation therapy for non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two different regimens of chemotherapy and radiation therapy in treating patients who have unresectable stage I stage II or stage III non-small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two different regimens of chemotherapy and radiation therapy in treating patients who have unresectable stage I stage II or stage III non-small cell lung cancer
Detailed Description:
OBJECTIVES
Compare survival disease-free survival local control and pattern of recurrence in patients with unresectable stage I II or low-volume stage III non-small lung cancer treated with high-dose radiotherapy either preceded by induction chemotherapy with gemcitabine and cisplatin or combined with daily cisplatin
Compare the acute and late toxic effects of these regimens in these patients
Determine the quality of life of these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to performance status 0 vs 1 TNM stage and participating center Patients are randomized to one of two treatment arms
Arm I Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 3-6 hours on day 2 Treatment is repeated once 21 days later Patients undergo high-dose accelerated conformal radiotherapy beginning on week 9 day 57 5 days a week for 24 fractions using a concurrent boost technique up to 66 Gy
Arm II Patients receive low-dose cisplatin IV followed 1-2 hours later by high-dose accelerated conformal radiotherapy Treatment continues daily 5 days a week for 24 fractions using a concurrent boost technique up to 66 Gy
Quality of life is assessed before treatment and at weeks 9-11 19 27 and 35
Patients are followed at 3 weeks 6-7 weeks and then every 8 weeks thereafter
PROJECTED ACCRUAL A total of 418 patients 209 per arm will be accrued for this study within 5 years
Compare survival disease-free survival local control and pattern of recurrence in patients with unresectable stage I II or low-volume stage III non-small lung cancer treated with high-dose radiotherapy either preceded by induction chemotherapy with gemcitabine and cisplatin or combined with daily cisplatin
Compare the acute and late toxic effects of these regimens in these patients
Determine the quality of life of these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to performance status 0 vs 1 TNM stage and participating center Patients are randomized to one of two treatment arms
Arm I Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 3-6 hours on day 2 Treatment is repeated once 21 days later Patients undergo high-dose accelerated conformal radiotherapy beginning on week 9 day 57 5 days a week for 24 fractions using a concurrent boost technique up to 66 Gy
Arm II Patients receive low-dose cisplatin IV followed 1-2 hours later by high-dose accelerated conformal radiotherapy Treatment continues daily 5 days a week for 24 fractions using a concurrent boost technique up to 66 Gy
Quality of life is assessed before treatment and at weeks 9-11 19 27 and 35
Patients are followed at 3 weeks 6-7 weeks and then every 8 weeks thereafter
PROJECTED ACCRUAL A total of 418 patients 209 per arm will be accrued for this study within 5 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 |
|---|---|---|---|
| EORTC-08972 | None | None | None |