Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00433563
Status:
COMPLETED
Last Update Posted:
2022-09-08
First Post:
2007-02-08
Brief Title:
Concurrent Once Daily Versus Twice Daily Radiotherapy for Limited Stage Small Cell Lung Cancer
Sponsor:
The Christie NHS Foundation Trust
Organization:
The Christie NHS Foundation Trust
Study Overview
Official Title:
A 2-Arm Randomized Controlled Trial of Concurrent Chemo-Radiotherapy Comparing Twice-Daily and Once-Daily Radiotherapy Schedules in Patients With Limited Stage Small Cell Lung Cancer SCLC and Good Performance Status CONVERT
Status:
COMPLETED
Status Verified Date:
2022-09
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:
CONVERT
Brief Summary:
RATIONALE Drugs used in chemotherapy such as cisplatin and etoposide work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Radiation therapy uses high-energy x-rays to kill tumor cells It is not yet known which schedule of radiation therapy is more effective when given together with chemotherapy in treating small cell lung cancer
PURPOSE This randomized phase III trial is studying two different schedules of radiation therapy to compare how well they work when given together with cisplatin and etoposide in treating patients with limited stage small cell lung cancer
PURPOSE This randomized phase III trial is studying two different schedules of radiation therapy to compare how well they work when given together with cisplatin and etoposide in treating patients with limited stage small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Compare overall survival of patients with limited stage small cell lung cancer treated with chemoradiotherapy comprising cisplatin etoposide and once vs twice daily radiotherapy
Secondary
Compare local progression-free survival of patients treated with these regimens
Compare metastasis-free survival of patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare response rates in patients treated with these regimens
Compare the cytotoxic dose intensity of these regimens in these patients
Compare the dose intensity of two different schedules of radiotherapy in these patients
OUTLINE This is a multicenter randomized controlled study Patients are stratified according to participating center ECOG performance status 0-1 vs 2 and lactic dehydrogenase sodium and alkaline phosphatase levels Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cisplatin IV over 2 hours on days 1-3 OR on day 1 only and etoposide IV over 45-90 minutes on days 1-3 Treatment repeats every 21 days for up to 6 courses During course 2 patients undergo concurrent radiotherapy once daily 5 days a week for 6½ weeks total of 33 fractions
Arm II Patients receive cisplatin and etoposide as in arm I During courses 2 and 3 patients undergo concurrent radiotherapy twice daily 5 days a week for 3 weeks total of 30 fractions
In both arms treatment continues in the absence of disease progression or unacceptable toxicity
Beginning 3-4 weeks after completion of chemoradiotherapy patients in both arms achieving a complete or partial response with no evidence of brain metastasis undergo prophylactic cranial irradiation once daily 5 days a week for 2 weeks total of 10 fractions
After completion of study treatment patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 532 patients will be accrued for this study
Primary
Compare overall survival of patients with limited stage small cell lung cancer treated with chemoradiotherapy comprising cisplatin etoposide and once vs twice daily radiotherapy
Secondary
Compare local progression-free survival of patients treated with these regimens
Compare metastasis-free survival of patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare response rates in patients treated with these regimens
Compare the cytotoxic dose intensity of these regimens in these patients
Compare the dose intensity of two different schedules of radiotherapy in these patients
OUTLINE This is a multicenter randomized controlled study Patients are stratified according to participating center ECOG performance status 0-1 vs 2 and lactic dehydrogenase sodium and alkaline phosphatase levels Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cisplatin IV over 2 hours on days 1-3 OR on day 1 only and etoposide IV over 45-90 minutes on days 1-3 Treatment repeats every 21 days for up to 6 courses During course 2 patients undergo concurrent radiotherapy once daily 5 days a week for 6½ weeks total of 33 fractions
Arm II Patients receive cisplatin and etoposide as in arm I During courses 2 and 3 patients undergo concurrent radiotherapy twice daily 5 days a week for 3 weeks total of 30 fractions
In both arms treatment continues in the absence of disease progression or unacceptable toxicity
Beginning 3-4 weeks after completion of chemoradiotherapy patients in both arms achieving a complete or partial response with no evidence of brain metastasis undergo prophylactic cranial irradiation once daily 5 days a week for 2 weeks total of 10 fractions
After completion of study treatment patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 532 patients will be accrued for this study
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 |
|---|---|---|---|
| CHNT-CTAAC-CONVERT-C17052A815 | OTHER_GRANT | Cancer Research UK | None |
| CHNT-CONVERT | OTHER | None | None |