NCT00193141

Brief Summary

In this randomized study, we plan to address the important question of optimum local treatment for patients with localized esophageal cancer. All patients will receive our previously studied neo-adjuvant regimen including paclitaxel, carboplatin, infusional 5-FU, and radiation therapy to 45 Gy. At the completion of neo-adjuvant therapy, patients will be randomized to undergo surgical resection, or to continue radiation to a total dose of 60 Gy, along with one additional course of chemotherapy.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 1999

Longer than P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

May 3, 2011

Status Verified

May 1, 2011

Enrollment Period

5 years

First QC Date

September 12, 2005

Last Update Submit

May 2, 2011

Conditions

Esophagus Cancer

Outcome Measures

Primary Outcomes (1)

  • To compare the efficacy of full dose radiation therapy versus preoperative radiation therapy plus surgical resection, when used in combination with neo-adjuvant chemotherapy, in the treatment of localized esophageal cancer

Secondary Outcomes (3)

  • To compare the toxicity of these two treatment approaches in localized esophageal cancer

  • To evaluate the utility of clinical restaging in guiding local therapy (surgical resection vs definitive radiation therapy) following neo-adjuvant treatment

  • To evaluate the toxicity of additional chemotherapy and radiation therapy following completion of neo-adjuvant treatment.

Interventions

PaclitaxelDRUG
CarboplatinDRUG
5-FluorouracilDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be included in this study, you must meet the following criteria:
  • Cancer of the esophagus or gastroesophageal junction confirmed by biopsy (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) clinical stage I, II, or III.
  • Received no previous treatment for esophageal cancer.
  • Measurable or evaluable disease
  • Able to perform activities of daily living with minimal assistance
  • Adequate bone marrow, liver and kidney function
  • Be at least 3 weeks from any major surgical procedures.
  • Have an indwelling central venous access catheter.
  • Patients must be able to understand the nature consent of the study and give written informed consent.

You may not qualify if:

  • You cannot participate in this study if any of the following apply to you:
  • Age \< 18 years
  • History of a prior malignancy within the past 5 years
  • History of significant heart disease
  • Inoperable on the basis of co-existent medical problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hainsworth JD, Meluch AA, Gray JR, Spigel DR, Meng C, Bearden JD, Hermann R, Greco FA. Concurrent chemoradiation followed by esophageal resection vs chemoradiation alone for localized esophageal cancer. Community Oncology 4:431-439, 2007.

    RESULT

Related Links

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

PaclitaxelCarboplatinFluorouracil

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination ComplexesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • John D. Hainsworth, MD

    SCRI Development Innovations, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

October 1, 1999

Primary Completion

October 1, 2004

Study Completion

July 1, 2007

Last Updated

May 3, 2011

Record last verified: 2011-05