Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002858
Status:
UNKNOWN
Last Update Posted:
2009-02-09
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Small Cell Lung Cancer
Sponsor:
Gustave Roussy Cancer Campus Grand Paris
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PHASE III STUDY COMPARING TWO DOSES OF INDUCTION CHEMOTHERAPY FOLLOWED BY ALTERNATION OF CHEMOTHERAPY AND RADIOTHERAPY IN LIMITED SMALL CELL LUNG CANCER
Status:
UNKNOWN
Status Verified Date:
2007-05
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 Radiation therapy uses high-energy x-rays to damage tumor cells Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells It is not yet known which treatment regimen is more effective for small cell lung cancer
PURPOSE Randomized phase III trial to study the effectiveness of combination chemotherapy using two different doses of cyclophosphamide followed by alternating chemotherapy and radiation therapy in treating patients with small cell lung cancer
PURPOSE Randomized phase III trial to study the effectiveness of combination chemotherapy using two different doses of cyclophosphamide followed by alternating chemotherapy and radiation therapy in treating patients with small cell lung cancer
Detailed Description:
OBJECTIVES I Compare the effect on 2-year disease-free survival of two different doses of cyclophosphamide as part of first induction chemotherapy followed by alternating chemotherapy and chest irradiation in patients with limited stage small cell lung cancer
OUTLINE This is a randomized study Patients are stratified by participating institution All patients receive 2 courses of induction chemotherapy with doxorubicin etoposide cisplatin and cyclophosphamide For the first course one group of patients receives a lower dose of cyclophosphamide than the other group Both groups receive the same and still lower dose of cyclophosphamide during the second course Beginning 1 week after the completion of induction therapy patients receive 3 alternating courses each of radiotherapy to the mediastinal and supraclavicular areas delivered over 10-12 days and chemotherapy as in the second course of induction Each course is initiated after a 1-week rest Patients receive a final chemotherapy course beginning 4 weeks after the previous chemotherapy course Patients are followed every 6 months for survival
PROJECTED ACCRUAL A total of 280 patients will be entered
OUTLINE This is a randomized study Patients are stratified by participating institution All patients receive 2 courses of induction chemotherapy with doxorubicin etoposide cisplatin and cyclophosphamide For the first course one group of patients receives a lower dose of cyclophosphamide than the other group Both groups receive the same and still lower dose of cyclophosphamide during the second course Beginning 1 week after the completion of induction therapy patients receive 3 alternating courses each of radiotherapy to the mediastinal and supraclavicular areas delivered over 10-12 days and chemotherapy as in the second course of induction Each course is initiated after a 1-week rest Patients receive a final chemotherapy course beginning 4 weeks after the previous chemotherapy course Patients are followed every 6 months for survival
PROJECTED ACCRUAL A total of 280 patients will be entered
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 |
|---|---|---|---|
| EU-96009 | None | None | None |
| FRE-CPC014 | None | None | None |