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Molecular Phenotyping in Predicting Response in Patients With Stage IB-III Esophageal Cancer Receiving Combination Chemotherapy

NCT02392377 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2018-02-13

Study results available
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Summary

This randomized pilot phase II trial studies how well molecular phenotyping works in predicting response in patients with stage IB-III esophageal cancer who are receiving carboplatin and paclitaxel or oxaliplatin, leucovorin calcium, and fluorouracil. Studying the genes in a patients tumor cells before and after chemotherapy may help in understanding if there are specific features of the tumor cells that make a person more or less likely to respond to treatment and how these features may be affected by treatment.

Conditions

  • Stage IB Esophageal Adenocarcinoma
  • Stage IIA Esophageal Adenocarcinoma
  • Stage IIB Esophageal Adenocarcinoma
  • Stage IIIA Esophageal Adenocarcinoma
  • Stage IIIB Esophageal Adenocarcinoma
  • Stage IIIC Esophageal Adenocarcinoma

Interventions

DRUG

Paclitaxel

Given IV or IVPB

DRUG

Carboplatin

Given IV or IVPB

DRUG

Oxaliplatin

Given IV

DRUG

Leucovorin Calcium

Given IV

DRUG

Fluorouracil

Given IV

RADIATION

Radiation Therapy

Undergo radiation therapy

PROCEDURE

Therapeutic Conventional Surgery

Undergo esophagectomy

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Jennifer Eads · Case Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02392377 on ClinicalTrials.gov