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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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NCT00655876

A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery

Unique Dataset IDnci-data-423ClinicalTrial.gov IDNCT00655876
DownloadableNo
SponsorRadiation Therapy Oncology GroupData ProviderNational Cancer InstituteTotal Study Enrolled Patients344RandomizationYesPubMed (PMID)28687830.0
Study PhaseN/ABlinding MethodOtherType(s) of dataN/AIntervention TypeN/ADataset TypeN/A

Clinical Trial Title

A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery

Trial Summary and Conditions

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as cetuximab, 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. Cetuximab may stop the growth of esophageal cancer by blocking blood flow to the tumor. It is not yet known whether giving paclitaxel and cisplatin together with radiation therapy is more effective with or without cetuximab in treating esophageal cancer. PURPOSE: This randomized phase III trial is comparing how well giving paclitaxel and cisplatin together with radiation therapy works with or without cetuximab in treating patients with locally advanced esophageal cancer.

Data Summary

See Data Dictionary.

Study Objectives

Primary: To evaluate whether the addition of cetuximab to chemotherapy comprising paclitaxel, cisplatin, and radiotherapy improves overall survival compared with paclitaxel, cisplatin, and radiotherapy alone in patients with esophageal cancer treated without surgery. Secondary: To evaluate whether the addition of cetuximab to paclitaxel, cisplatin, and radiotherapy improves local control by increasing the clinical complete response and decreasing local recurrence in these patients; To evaluate adverse events in these patients; To evaluate endoscopic complete response rates in these patients; To evaluate if the addition of cetuximab to paclitaxel, cisplatin, and radiotherapy improves the Esophageal Cancer Subscale (ECS) score of the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) quality of life tool; To evaluate the quality-adjusted survival of each treatment arm using EQ-5D if the primary endpoint supports the primary hypothesis.

Outcome Measures

Primary:Overall Survival (24-month Rate Reported) [Time Frame: From randomization to last follow-up. Analysis was planned to occur after at least 281 deaths had been observed. Maximum follow-up at time of analysis was 74.5 months] Secondary:Local Failure (24-month Rate Reported) [Time Frame: From randomization to last follow-up. Analysis was planned to occur after at least 281 deaths had been observed. Maximum follow-up at time of analysis was 74.5 months.]; Percentage of Patients With Acute Grade 4 or 5 Non-hematologic Treatment-related Adverse Events [Time Frame: From start of treatment to 90 days from end of treatment]; Endoscopic Complete Response Rate [ Time Frame: From randomization to 6-8 weeks after completion of chemoradiation (11-14 weeks)]; Percentage of Patients With Improvement in the Functional Assessment of Cancer Therapy - Esophagus (FACT-E) Esophageal Cancer Subscale (ECS) Subscale After Treatment [Time Frame: Baseline, 6-8 weeks after completion of chemoradiation , 1

ClinicalTrial.gov

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

NCI Description

This dataset will allow users to reproduce the treatment comparison in trial NCT00655876.

Available Downloads: NCT00655876-D1

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

Data Dictionary: NCT00655876-D1-Data-Dictionary_1.pdf

DATA: NCT00655876-D1-Dataset.csv

OTHER: README.pdf

Available Downloads: NCT00655876-D2

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

Data Dictionary: NCT00655876-D2-Data-Dictionary_1.pdf

DATA: NCT00655876-D2-Dataset.csv

OTHER: README.pdf