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Trial of XELOX Followed by Radiation Combined With Carboplatin and RAD001 for Esophageal Cancer

NCT01490749 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2019-03-15

No results posted yet for this study

Summary

The purpose of this study is to test the drug RAD001 in combination with another chemotherapy drug, Carboplatin, as well as radiation therapy in the treatment of esophageal cancer. Because RAD001 has not been used in this combination before, it is not clear which dose will be best when used in combination.

The standard of care for patients who have esophageal cancer that has not moved to other areas of the body (non-metastatic) includes a combination of chemotherapy, radiation therapy and possibly surgery. If the patient chooses to participate in this study, the patient will receive chemotherapy and radiation therapy. The patient will possibly also have surgery to have the cancer removed. This decision will be made by the treating physicians. All of the chemotherapy the patient will receive on the study is considered standard chemotherapy for esophagus cancer. The investigators do not know as of yet if the drug called RAD001 will help improve the treatment for patients with this disease. RAD001 is a pill that has been used in many other types of cancer and has been proven to be effective in other cancers such as kidney cancer.

Conditions

  • Esophageal Cancer
  • Neoplasms, Esophageal

Interventions

DRUG

RAD001

Dose escalation for Phase I; dose for Phase II to be determined after Phase I is completed.

DRUG

XELOX

Patients will receive two cycles of XELOX.

DRUG

Carboplatin

Given on a 3 weeks on and 1 week off schedule.

RADIATION

Radiation

1.8 Gy to 36 Gy; 3 fields or laterals to 50.4 Gy.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Emory University

    lead OTHER

Principal Investigators

  • Nabil F. Saba, MD · Emory University Winship Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2019-02-28
Completion
2019-02-28

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT01490749 on ClinicalTrials.gov