Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002822
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Followed by Radiation Therapy in Patients With Small Cell Lung Cancer
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
RANDOMISED CLINICAL TRIAL OF IFOSFAMIDE CARBOPLATIN AND ETOPOSIDE WITH MID-CYCLE VINCRISTINE VICE VERSUS STANDARD PRACTICE CHEMOTHERAPY IN PATIENTS WITH LIMITED STAGE SMALL CELL LUNG CANCER SCLC AND GOOD PERFORMANCE STATUS
Status:
COMPLETED
Status Verified Date:
2000-12
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 Combining more than one drug is a way to kill more tumor cells Combining radiation therapy with chemotherapy may kill more tumor cells
PURPOSE Randomized phase III trial to compare the effect of two combination chemotherapy regimens followed by radiation therapy in treating patients with small cell lung cancer
PURPOSE Randomized phase III trial to compare the effect of two combination chemotherapy regimens followed by radiation therapy in treating patients with small cell lung cancer
Detailed Description:
OBJECTIVES
Compare the survival rate in patients with newly diagnosed small cell lung cancer and good performance status treated with an intensive regimen of ifosfamidecarboplatinetoposide with mid-cycle vincristine VICE vs standard chemotherapy followed as feasible by thoracic radiotherapy
Compare the adverse effects of treatment and quality of life including psychological distress physical status and functional status and global quality of life in these patients
Compare the Rotterdam Symptom Checklist vs the EORTC QLQ-C30 and LC13 quality-of-life questionnaires in relation to compliance and ability to detect differences between treatments
OUTLINE This is a randomized study
The first group receives standard combination chemotherapy with doxorubicincyclophosphamideetoposide ACE or cisplatinetoposide PE every 3 weeks for 6 courses
The second group receives intensive combination chemotherapy with carboplatinifosfamideetoposide on days 1-3 with vincristine on day 14 VICE Courses repeat every 4 weeks for 6 courses
Patients in both groups are considered for thoracic radiotherapy beginning 4-5 weeks after the first day of the last course of chemotherapy
Concurrent prophylactic antibiotics should be given Patients who relapse may receive further treatment at the clinicians option
Patients are followed monthly for 6 months every 2 months for up to 1 year every 3 months for up to 2 years every 6 months for 5 years and annually thereafter
PROJECTED ACCRUAL A total of 400 patients will be entered over 3 years
Compare the survival rate in patients with newly diagnosed small cell lung cancer and good performance status treated with an intensive regimen of ifosfamidecarboplatinetoposide with mid-cycle vincristine VICE vs standard chemotherapy followed as feasible by thoracic radiotherapy
Compare the adverse effects of treatment and quality of life including psychological distress physical status and functional status and global quality of life in these patients
Compare the Rotterdam Symptom Checklist vs the EORTC QLQ-C30 and LC13 quality-of-life questionnaires in relation to compliance and ability to detect differences between treatments
OUTLINE This is a randomized study
The first group receives standard combination chemotherapy with doxorubicincyclophosphamideetoposide ACE or cisplatinetoposide PE every 3 weeks for 6 courses
The second group receives intensive combination chemotherapy with carboplatinifosfamideetoposide on days 1-3 with vincristine on day 14 VICE Courses repeat every 4 weeks for 6 courses
Patients in both groups are considered for thoracic radiotherapy beginning 4-5 weeks after the first day of the last course of chemotherapy
Concurrent prophylactic antibiotics should be given Patients who relapse may receive further treatment at the clinicians option
Patients are followed monthly for 6 months every 2 months for up to 1 year every 3 months for up to 2 years every 6 months for 5 years and annually thereafter
PROJECTED ACCRUAL A total of 400 patients will be entered over 3 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 |
|---|---|---|---|
| EU-96019 | None | None | None |
| MRC-LU21 | None | None | None |