Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077064
Status:
TERMINATED
Last Update Posted:
2018-03-08
First Post:
2004-02-10
Brief Title:
Captopril in Treating Patients With Non-Small Cell Lung Cancer or Limited-Stage Small Cell Lung Cancer That Has Been Previously Treated With Radiation Therapy With or Without Chemotherapy
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase II Randomized Trial With Captopril In Patients Who Have Received Radiation Therapy - Chemotherapy For Stage II-IIIB Non-Small Cell Lung Cancer Stage I Central Non-Small Cell Lung Cancer Or Limited-Stage Small-Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to unmet accrualrandomization goals
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Captopril is a drug that may be able to decrease side effects caused by radiation therapy and may improve the quality of life of patients with non-small cell lung cancer or limited-stage small cell lung cancer
PURPOSE This randomized phase II trial is studying how well captopril works in decreasing side effects and improving the quality of life in patients who have received radiation therapy with or without chemotherapy for stage I stage II or stage IIIB non-small cell lung cancer or limited-stage small cell lung cancer
PURPOSE This randomized phase II trial is studying how well captopril works in decreasing side effects and improving the quality of life in patients who have received radiation therapy with or without chemotherapy for stage I stage II or stage IIIB non-small cell lung cancer or limited-stage small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the effect of captopril on the incidence of pulmonary damage at 12 months after radiotherapy with or without chemotherapy in patients with stage II-IIIB non-small cell lung cancer stage I central non-small cell lung cancer or limited stage small cell lung cancer
Compare the quality of life of patients treated with captopril vs patients who undergo post-radiotherapy observation only
Determine the persistence of captoprils effect on pulmonary toxicity in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center total lung irradiated 25 vs 25-37 vs more than 37 prior surgery yes vs no and prior chemotherapy yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral captopril 3 times daily for 1 year in the absence of disease progression or unacceptable toxicity
Arm II Patients undergo observation only for 1 year Quality of life is assessed at baseline and at months 3 6 12 and 18
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 205 patients will be accrued for this study within 18 months
Determine the effect of captopril on the incidence of pulmonary damage at 12 months after radiotherapy with or without chemotherapy in patients with stage II-IIIB non-small cell lung cancer stage I central non-small cell lung cancer or limited stage small cell lung cancer
Compare the quality of life of patients treated with captopril vs patients who undergo post-radiotherapy observation only
Determine the persistence of captoprils effect on pulmonary toxicity in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center total lung irradiated 25 vs 25-37 vs more than 37 prior surgery yes vs no and prior chemotherapy yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral captopril 3 times daily for 1 year in the absence of disease progression or unacceptable toxicity
Arm II Patients undergo observation only for 1 year Quality of life is assessed at baseline and at months 3 6 12 and 18
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 205 patients will be accrued for this study within 18 months
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 |
|---|---|---|---|
| CDR0000315569 | None | None | None |
| RTOG-L-0123 | None | None | None |