NCT00139633

Brief Summary

This prospective study was designed to assess the outcomes (survival and failure patterns) of therapy for localized esophageal cancer with conventional dose radiation (RT; 50.4 Gy) with concurrent continuous infusion 5-fluorouracil (5-FU) and weekly carboplatin/paclitaxel. Patients with less than complete response (CR) or partial response (PR) received dose escalation of radiation to 59.4 Gy with the same chemotherapy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2000

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2000

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2005

Completed
Last Updated

August 31, 2005

Status Verified

August 1, 2005

First QC Date

August 29, 2005

Last Update Submit

August 29, 2005

Conditions

Esophageal Cancer

Keywords

esophageal cancer, chemotherapy, radiation

Outcome Measures

Primary Outcomes (2)

  • survival at 4 years

  • local control at 4 years

Interventions

carboplatin, 5FU, Taxol and radiationDRUG

Eligibility Criteria

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

You may qualify if:

  • T1-4, N0-1, M0-1a esophageal carcinoma

You may not qualify if:

  • distant metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Oregon Clinic

Portland, Oregon, 97213, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

CarboplatinFluorouracilPaclitaxelRadiation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesPhysical Phenomena

Study Officials

  • Steven K Seung, MDPhD

    The Oregon Clinic

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 31, 2005

Study Start

July 1, 2000

Study Completion

June 1, 2005

Last Updated

August 31, 2005

Record last verified: 2005-08

Locations

US(1)