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Colorectal

CALGB 9581: Phase III Randomized Study of Adjuvant Immunotherapy with Monoclonal Antibody 17-1A Versus No Adjuvant Therapy Following Resection for Stage II (Modified Astler-Coller B2) Adenocarcinoma of the Colon

Unique Data Set IDColorec_Allianc_1997_182
DownloadableYes
SponsorAlliance for Clinical Trials in OncologyData ProviderThe Alliance for Clinical Trials in OncologyTotal Study Enrolled Patients1738Experimental (Active) Arm Enrolled Patients865RandomizationYesClinicalTrial.gov IDN/AClinicalTrial.gov URLN/A
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataOnly experimental arm dataIntervention TypeChemotherapyData Set TypeOther

Clinical Trial Title

CALGB 9581: Phase III Randomized Study of Adjuvant Immunotherapy with Monoclonal Antibody 17-1A Versus No Adjuvant Therapy Following Resection for Stage II (Modified Astler-Coller B2) Adenocarcinoma of the Colon

Trial Summary and Conditions

Randomized phase III trial to compare the effectiveness of surgery with or without monoclonal antibody therapy in treating patients who have stage II colon cancer. Monoclonal antibodies such as edrecolomab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether surgery to remove colon cancer is more effect with or without monoclonal antibody therapy.

Data Summary

Primary and secondary efficacy, safety and baseline demographic data.

Study Objectives

I. 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.

Outcome Measures

Efficacy outcome measures - Overall Survival (OS) and Disease-Free Survival (DFS) Secondary outcome measures include baseline patient characteristics, adverse events (AEs), baseline laboratory findings, and baseline tumor characteristics.

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: 9581 protocol.doc

CRF: 9581_all_forms.pdf

DATA DICTIONARY: Data_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