Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003313
Status:
COMPLETED
Last Update Posted:
2014-11-21
First Post:
1999-11-01
Brief Title:
Amifostine in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase III Randomized Study of Amifostine Mucosal Protection for Patients With Favorable Performance Inoperable Stage II-III AB Non-Small Cell Lung Cancer NSCLC Receiving Sequential Induction and Concurrent Hyperfractionated Radiotherapy With Paclitaxel and Carboplatin
Status:
COMPLETED
Status Verified Date:
2014-11
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 Amifostine may be an effective treatment for the toxic side effects caused by radiation therapy and chemotherapy It is not yet known whether chemotherapy and radiation therapy are more effective with or without amifostine for non-small cell lung cancer
PURPOSE Randomized phase III trial to determine the effectiveness of amifostine in treating patients who have stage II or stage III non-small cell lung cancer that cannot be surgically removed and who are undergoing chemotherapy and radiation therapy
PURPOSE Randomized phase III trial to determine the effectiveness of amifostine in treating patients who have stage II or stage III non-small cell lung cancer that cannot be surgically removed and who are undergoing chemotherapy and radiation therapy
Detailed Description:
OBJECTIVES I Evaluate whether the addition of the radioprotector amifostine can reduce the incidence and severity of non-hematologic toxicity specifically esophagitis and pneumonitis during concurrent hyperfractionated radiotherapy and chemotherapy with paclitaxel and carboplatin in patients with stage II IIIA or IIIB non-small cell lung cancer II Evaluate the differences in quality of life and symptom distress specifically dysphagia between patients receiving amifostine and those not receiving amifostine III Evaluate the relationship of tobacco use and alcohol use during treatment to appraisals of quality of life and symptom distress specifically esophagitis in the two groups IV Evaluate the efficacy of induction therapy with paclitaxel and carboplatin followed by concurrent chemotherapy and hyperfractionated radiotherapy in these patients
OUTLINE This is an open-label treatment and randomized supportive care study Patients are stratified according to disease stage II vs IIIA vs IIIB Karnofsky performance status 90-100 vs 70-80 and age 70 and under vs over 70 Patients are randomized to one of two treatment arms Arm I Patients receive paclitaxel IV over 3 hours on days 1 and 22 and over 1 hour weekly for 6 weeks beginning on day 43 Patients receive carboplatin IV over 30 minutes immediately after each paclitaxel dose Patients receive filgrastim G-CSF subcutaneously for 10-14 days after each of the first two paclitaxel and carboplatin doses Radiotherapy begins on day 43 and is administered twice daily for 5 days per week for 6 weeks Beginning on day 43 patients receive amifostine IV over 5-7 minutes 4 days a week for 6 weeks Arm II Patients receive treatment as in arm I without amifostine Quality of life is assessed at baseline before chemoradiation after 2 courses of induction chemotherapy the last week of chemoradiation week 6 and at the 6-week follow-up visit Patients are followed at 1 month every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 244 patients 122 per treatment arm will be accrued for this study within 38 months
OUTLINE This is an open-label treatment and randomized supportive care study Patients are stratified according to disease stage II vs IIIA vs IIIB Karnofsky performance status 90-100 vs 70-80 and age 70 and under vs over 70 Patients are randomized to one of two treatment arms Arm I Patients receive paclitaxel IV over 3 hours on days 1 and 22 and over 1 hour weekly for 6 weeks beginning on day 43 Patients receive carboplatin IV over 30 minutes immediately after each paclitaxel dose Patients receive filgrastim G-CSF subcutaneously for 10-14 days after each of the first two paclitaxel and carboplatin doses Radiotherapy begins on day 43 and is administered twice daily for 5 days per week for 6 weeks Beginning on day 43 patients receive amifostine IV over 5-7 minutes 4 days a week for 6 weeks Arm II Patients receive treatment as in arm I without amifostine Quality of life is assessed at baseline before chemoradiation after 2 courses of induction chemotherapy the last week of chemoradiation week 6 and at the 6-week follow-up visit Patients are followed at 1 month every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 244 patients 122 per treatment arm will be accrued for this study within 38 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 |
|---|---|---|---|
| CDR0000066260 | None | None | None |