Ignite Creation Date:
2024-05-05 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 9:57 AM
Study NCT ID:
NCT00792701
Status:
COMPLETED
Last Update Posted:
2020-03-06
First Post:
2008-11-16
Brief Title:
S0720 Adjuvant Therapy Based on Gene Expression in Stage IA and IB Non-Small Cell Lung Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase II ERCC1 and RRM1-Based Adjuvant Therapy Trial in Patients With Stage I Non-Small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2020-02
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 such as gemcitabine and cisplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving chemotherapy drugs after surgery may kill any tumor cells that remain after surgery Sometimes after surgery the tumor may not need more treatment until it progresses In this case observation may be sufficient
PURPOSE This phase II trial is studying how well giving gemcitabine together with cisplatin works in treating patients with stage I non-small cell lung cancer that was removed by surgery
PURPOSE This phase II trial is studying how well giving gemcitabine together with cisplatin works in treating patients with stage I non-small cell lung cancer that was removed by surgery
Detailed Description:
OBJECTIVES
Primary
To assess the feasibility of assigning adjuvant treatment based on tumoral RRM1 and ERCC1 gene expression in patients with complete surgical resection of stage IA 2 cm or IB non-small cell lung cancer
Secondary
To estimate the collective 2-year disease-free survival of these patients
To assess the frequency and severity of toxicities resulting from the administration of cisplatin and gemcitabine hydrochloride
To explore preliminarily the relationship between RNA and protein expression of RRM1 and ERCC1 and the relationship between RRM1 and ERCC1 expression in the formalin-fixed and paraffin-embedded tumor specimens and to generate results on in situ protein expression and other assays for genes involved in drug efficacy
To assess the analytical performance of the biomarker assay
OUTLINE This is a multicenter study
Patients are assigned to 1 of 2 treatment arms based on RRM1 and ERCC1 gene expression
Arm I RRM1 40 and ERCC1 65 Patients undergo active monitoring after surgery with disease assessments at 8 16 and 24 weeks
Arm II RRM1 40 andor ERCC1 65 Beginning within 84 days after surgery patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-90 minutes on day 1 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Tumor samples acquired at the time of surgery are analyzed by immunofluorescence-based automated quantitative analysis for in situ expression of RRM1 and ERCC1 If available additional samples are assessed using RT-PCR and real-time quantitative PCR for RRM1 and ERCC1 expression levels polymorphism analysis for RRM1 and ERCC1 expression at the protein level and tissue microarray analysis of genes associated with DNA synthesis damage repair and drug efficacy
After completion of study therapy patients are followed every 6 months for up to 2 years
Primary
To assess the feasibility of assigning adjuvant treatment based on tumoral RRM1 and ERCC1 gene expression in patients with complete surgical resection of stage IA 2 cm or IB non-small cell lung cancer
Secondary
To estimate the collective 2-year disease-free survival of these patients
To assess the frequency and severity of toxicities resulting from the administration of cisplatin and gemcitabine hydrochloride
To explore preliminarily the relationship between RNA and protein expression of RRM1 and ERCC1 and the relationship between RRM1 and ERCC1 expression in the formalin-fixed and paraffin-embedded tumor specimens and to generate results on in situ protein expression and other assays for genes involved in drug efficacy
To assess the analytical performance of the biomarker assay
OUTLINE This is a multicenter study
Patients are assigned to 1 of 2 treatment arms based on RRM1 and ERCC1 gene expression
Arm I RRM1 40 and ERCC1 65 Patients undergo active monitoring after surgery with disease assessments at 8 16 and 24 weeks
Arm II RRM1 40 andor ERCC1 65 Beginning within 84 days after surgery patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-90 minutes on day 1 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Tumor samples acquired at the time of surgery are analyzed by immunofluorescence-based automated quantitative analysis for in situ expression of RRM1 and ERCC1 If available additional samples are assessed using RT-PCR and real-time quantitative PCR for RRM1 and ERCC1 expression levels polymorphism analysis for RRM1 and ERCC1 expression at the protein level and tissue microarray analysis of genes associated with DNA synthesis damage repair and drug efficacy
After completion of study therapy patients are followed every 6 months for up to 2 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 |
|---|---|---|---|
| S0720 | OTHER | None | None |
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |