Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00309972
Status:
COMPLETED
Last Update Posted:
2014-12-03
First Post:
2006-03-29
Brief Title:
Cisplatin Vinorelbine and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery
Sponsor:
University College London
Organization:
University College London
Study Overview
Official Title:
A Randomized Phase III Trial of Sequential Chemotherapy Followed By Radical Radiotherapy Versus Concurrent Chemo-Radiotherapy Followed by Chemotherapy in Patients With Inoperable Stage III Non-Small Cell Lung Cancer and Good Performance Status
Status:
COMPLETED
Status Verified Date:
2012-03
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:
SOCCAR
Brief Summary:
RATIONALE Drugs used in chemotherapy such as cisplatin and vinorelbine 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 whether giving combination chemotherapy followed by radiation therapy is more effective than giving combination chemotherapy together with radiation therapy followed by more chemotherapy in treating non-small cell lung cancer
PURPOSE This randomized phase III trial is studying combination chemotherapy followed by radiation therapy to see how well it works compared to combination chemotherapy combined with radiation therapy followed by more chemotherapy in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery
PURPOSE This randomized phase III trial is studying combination chemotherapy followed by radiation therapy to see how well it works compared to combination chemotherapy combined with radiation therapy followed by more chemotherapy in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Compare the overall survival of patients with stage III non-small cell cancer treated with chemotherapy comprising cisplatin and vinorelbine ditartrate CV followed by radical radiotherapy versus concurrent CV chemoradiotherapy followed by CV chemotherapy
Secondary
Compare the progression-free survival of patients treated with these regimens
Compare the local progression-free survival local control
Compare the hematological pulmonary esophageal and neurological toxicities
Compare the response
Compare the quality of life
Compare the cost-effectiveness
OUTLINE This is a randomized multicenter study Patients are stratified according to clinically important factors Patients are randomized to 1 of 2 treatment arms
Arm I sequential treatment Patients receive cisplatin IV over 2 hours on day 1 and vinorelbine ditartrate IV over 5-10 minutes on days 1 and 8 Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Beginning in week 15 patients undergo radiotherapy 5 days a week for 4 weeks
Arm II concurrent treatment Patients undergo radiotherapy as in arm I beginning in week 1 Patients receive cisplatin IV over 2 hours on days 1-4 and vinorelbine ditartrate IV over 5-10 minutes on days 1 and 8 Chemotherapy repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline monthly for 6 months and then at each follow-up visit
After completion of study treatment patients are followed periodically
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 508 patients will be accrued for this study
Primary
Compare the overall survival of patients with stage III non-small cell cancer treated with chemotherapy comprising cisplatin and vinorelbine ditartrate CV followed by radical radiotherapy versus concurrent CV chemoradiotherapy followed by CV chemotherapy
Secondary
Compare the progression-free survival of patients treated with these regimens
Compare the local progression-free survival local control
Compare the hematological pulmonary esophageal and neurological toxicities
Compare the response
Compare the quality of life
Compare the cost-effectiveness
OUTLINE This is a randomized multicenter study Patients are stratified according to clinically important factors Patients are randomized to 1 of 2 treatment arms
Arm I sequential treatment Patients receive cisplatin IV over 2 hours on day 1 and vinorelbine ditartrate IV over 5-10 minutes on days 1 and 8 Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Beginning in week 15 patients undergo radiotherapy 5 days a week for 4 weeks
Arm II concurrent treatment Patients undergo radiotherapy as in arm I beginning in week 1 Patients receive cisplatin IV over 2 hours on days 1-4 and vinorelbine ditartrate IV over 5-10 minutes on days 1 and 8 Chemotherapy repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline monthly for 6 months and then at each follow-up visit
After completion of study treatment patients are followed periodically
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 508 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 |
|---|---|---|---|
| C11922A4558 | OTHER_GRANT | None | None |
| 13746987 | OTHER | None | None |
| EU-20602 | OTHER | None | None |
| 2004-001920-19 | EUDRACT_NUMBER | UCL CTC | None |