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Type(s) of Cancer
Colorectal
Study Phase
Phase 3
Study Completion Date
1997
NCT00002968Uploaded 05-01-2017
Available for Download
PDS UID: Colorec_Allianc_1997_182
N/A
Provider Information
Provider Data DescriptionI. To determine whether adjuvant treatment with MoAb 17-1A will improve the probability of overall and disease-free survival, and increase disease-free intervals in patients who have undergone resection of a Stage II colon cancer. II. To determine whether alterations in the expression of cell cycle related genes (thymidylate synthase, p53, and the cyclin-dependent kinase inhibitors p21 and p27) predict the risk of survival and recurrence in this patient population. III. To determine whether alterations in markers of metastatic potential-expression of DCC and measures of tumor angiogenesis (microvascular density and vascular endothelial growth factor expression)-predict the risk of survival and recurrence in this patient population. IV. To determine whether a marker of cellular differentiation-sucrase isomaltase-predicts the risk of survival and recurrence in this patient population. V. To determine whether DNA ploidy and cell proliferation are prognostic of tumor recurrence and overall survival in Stage II colon cancer. VI. To determine whether interactions among these tumor markers identify subsets of patients with significantly altered outcome. VII. To determine whether pathologic features including tumor grade; tumor mitotic (proliferation) index; tumor border configuration; host lymphoid response to tumor; and lymphatic vessel, venous vessel and perineural invasion predict outcome in this patient population.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderAlliance for Clinical Trials in Oncology
Partial set or SubsetOriginal Data
Patients in dataset1738
# of Patients ControlN/A
# of Patients Experimental865
DOIhttps://doi.org/10.34949/57rt-nr42
CDISC StandardExcel
Study ArmsExperimental arm data only
Clinical Trials.gov Information
Brief SummaryN/A
ConditionsN/A
Intervention TypeChemotherapy
Drug(s)N/A
Total EnrolledN/A
RandomizationN/A
Blinding MethodN/A
Arms InterventionN/A
Secondary IDN/A
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)N/A
Age RangeN/A
Files:
PROTOCOL9581 protocol.doc
CRF9581_all_forms.pdf
DATA DICTIONARYData_Dictionary.xlsx
DATA (ACTIVE ARM)new_primary_c1001.xlsx
DATA (ACTIVE ARM)off_trt_c300.xlsx
DATA (ACTIVE ARM)outcome_other_baseline_data.xlsx
DATA (ACTIVE ARM)adverse_event_c272.xlsx
DATA (ACTIVE ARM)onstudy_c437.xlsx
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