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This dataset is available to Authorized Users of the Project Data Sphere Cancer Research Platform through an initiative with the National Cancer Institute (NCI) of the U.S. National Institutes of Health (NIH). To gain access to this dataset, you must complete the following steps:

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Neuroendocrine Tumors

Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor

Unique Dataset IDnci-data-43
DownloadableNo
SponsorNational Cancer InstituteData ProviderNational Cancer InstituteTotal Study Enrolled Patients427RandomizationYesPubMed (PMID)28384065.00ClinicalTrial.gov IDNCT00569127ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00569127
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataN/AIntervention TypeDrug, BiologicalDataset TypeOther

NCI Description

This dataset will allow users to reproduce toxicity analyses reported in the Journal of Clinical Oncology (Yao et al., JCO, 2017, PMID referenced above), which included adverse events among patients with advanced NETs in the SWOG Phase III trial, S0518 (NCT00569127), receiving bevacizumab + octreotide or interferon alfa-2b + octreotide.

Clinical Trial Title

Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor

Trial Summary and Conditions

This randomized phase III trial is studying giving octreotide acetate together with recombinant interferon alfa-2b to see how well it works compared with giving octreotide acetate together with bevacizumab in treating patients with metastatic or locally advanced, high-risk neuroendocrine tumor. Octreotide acetate and recombinant interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving octreotide acetate together with recombinant interferon alfa-2b is more effective than giving octreotide acetate together with bevacizumab in treating patients with neuroendocrine tumor.

Data Summary

See data dictionary for more details.

Study Objectives

PRIMARY OBJECTIVES: I. To compare central review-based progression-free survival in poor prognosis carcinoid patients treated with either depot octreotide (octreotide acetate) plus bevacizumab, or depot octreotide plus interferon (recombinant interferon alfa-2b). II. To compare overall survival, time to treatment failure and traditionally reported progression-free survival in poor prognosis carcinoid patients treated with either depot octreotide plus bevacizumab, or depot octreotide plus interferon. III. To compare objective response (confirmed and unconfirmed CR and PR) in poor prognosis carcinoid patients treated with either depot octreotide plus bevacizumab, or depot octreotide plus interferon. IV. To compare the toxicity profile of patients treated with these two regimens. V. To assess the prognostic and predictive value of VEGF expression in relation to progression-free survival and treatment effect. VI. To compare response of 5HIAA, chromogranin A and neuronspecific enolase among patients with elevated levels at baseline between patients treated with octreotide plus interferon versus octreotide plus bevacizumab. VII. To assess and compare the prognostic and predictive value of the combination of In-111 pentetreotide somatostatin-receptor scintigraphy (SRS) and CT vs. CT in relation to progression-free survival (PFS). VIII. To assess and compare the prognostic and predictive value of the combination of SRS and CT vs. CT in relation to overall survival (OS) and time to treatment failure (TTF). OUTLINE: This is a multicenter study. Patients are stratified according to site of disease (small bowel vs cecum vs appendix vs other site), disease progression after initial diagnosis (yes or no), histologic grade (low vs intermediate [atypical]), and prior octreotide acetate therapy within the past 2 months (yes vs no). Patients are randomized to 1 of 2 treatment arms.

Outcome Measures

Primary: Central Review-based Progression-Free Survival [ Time Frame: Up to 3 years ] Secondary: Overall Survival [ Time Frame: Up to 7 years ] Time to Treatment Failure [ Time Frame: Up to 3 years ] Local Progression-Free Survival (Investigator Assessed) [ Time Frame: Up to 3 years ] Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response) [ Time Frame: Up to 3 years ] Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug [ Time Frame: Up to 3 years ]

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

Available Downloads:

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

Data Dictionary: NCT00569127-D2-Data-Dictionary_1.pdf

DATA: NCT00569127-D2-Dataset.csv

OTHER: README.pdf