Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003158
Status:
COMPLETED
Last Update Posted:
2012-07-24
First Post:
1999-11-01
Brief Title:
S9712 Radiation Therapy and Combination Chemotherapy in Treating Patients With Stage III Non-small Cell Lung Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase II Trial of Concurrent CarboplatinVP-16 and Radiation Followed by Paclitaxel Taxol for Poor-Risk Stage III Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2012-07
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 Radiation therapy uses high-energy x-rays to damage tumor cells Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of radiation therapy and chemotherapy consisting of carboplatin etoposide and paclitaxel in treating patients with newly diagnosed stage III non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of radiation therapy and chemotherapy consisting of carboplatin etoposide and paclitaxel in treating patients with newly diagnosed stage III non-small cell lung cancer
Detailed Description:
OBJECTIVES I Assess the survival and failure-free survival in poor risk patients with stage IIIA or IIIB non-small cell lung carcinoma treated with concurrent radiation carboplatin and etoposide followed by consolidation with paclitaxel II Evaluate the response and toxicities associated with this regimen in this group of poor risk patients
OUTLINE This is nonrandomized study Chemotherapy on cycle 1 starts on day 1 with concurrent initiation of radiotherapy Chemotherapy is given prior to radiotherapy on those days when both treatments are given Cycle 2 begins on day 29 Carboplatin is administered by 15 minute IV infusions on days 1 3 29 and 31 Etoposide VP-16 is administered after carboplatin by 30 minute IV infusions on days 1-4 and 29-32 Radiation therapy begins within 24 hours of day 1 cycle 1 of chemotherapy The primary tumor the adjacent mediastinum and other targeted lymph nodes are administered radiotherapy daily 5 days a week for 65 weeks After the 2 cycles of chemotherapy and chest radiotherapy patients who have stable disease partial response or complete response receive 3 cycles of paclitaxel Paclitaxel is administered by 3 hour IV infusions starting 4 weeks after completion of chemotherapy and radiotherapy and repeated every 3-4 weeks approximately days 71 92 and 103 for a total of 3 cycles Patients are followed every month for the first year every 3 months for the second year every 6 months for the third year and then annually thereafter while on treatment After treatment patients are followed every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL There will be 80 patients accrued in this study over 16 months
OUTLINE This is nonrandomized study Chemotherapy on cycle 1 starts on day 1 with concurrent initiation of radiotherapy Chemotherapy is given prior to radiotherapy on those days when both treatments are given Cycle 2 begins on day 29 Carboplatin is administered by 15 minute IV infusions on days 1 3 29 and 31 Etoposide VP-16 is administered after carboplatin by 30 minute IV infusions on days 1-4 and 29-32 Radiation therapy begins within 24 hours of day 1 cycle 1 of chemotherapy The primary tumor the adjacent mediastinum and other targeted lymph nodes are administered radiotherapy daily 5 days a week for 65 weeks After the 2 cycles of chemotherapy and chest radiotherapy patients who have stable disease partial response or complete response receive 3 cycles of paclitaxel Paclitaxel is administered by 3 hour IV infusions starting 4 weeks after completion of chemotherapy and radiotherapy and repeated every 3-4 weeks approximately days 71 92 and 103 for a total of 3 cycles Patients are followed every month for the first year every 3 months for the second year every 6 months for the third year and then annually thereafter while on treatment After treatment patients are followed every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL There will be 80 patients accrued in this study over 16 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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S9712 | OTHER | None | None |