NCT00593723

Brief Summary

Concurrent chemotherapy and radiation therapy are the standard of care for inoperable patients with esophagus cancer. Unfortunately, the 5-year survival of 20% for this population is quite low. Methods to intensify radiation therapy delivery without increasing local toxicities are needed. Intensity modulated radiation therapy (IMRT) is an advanced method of delivering external beam radiation that may minimize the volume of normal tissue irradiated to high dose and thus decrease the risk of normal tissue toxicity. The proposed study will prospectively test whether IMRT is tolerable for delivering IMRT doses of 60 Gy for patients with esophagus cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

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

December 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 5, 2016

Status Verified

April 1, 2016

Enrollment Period

7.1 years

First QC Date

January 2, 2008

Last Update Submit

April 3, 2016

Conditions

Esophagus Cancer

Keywords

IMRT

Outcome Measures

Primary Outcomes (1)

  • The study will evaluate the feasibility of using helical tomotherapy to deliver IMRT in patients with unresectable esophagus cancer.

    The study will be deemed infeasible if one or more of the following results occur: * 15% of patients experience any grade 4 acute toxicity judged to be related to his/her external radiation treatment * within 1 year of protocol registration, \>15% of patients develop any grade 4 late toxicity judged to be related to his/her external radiation treatment * within 1 year of protocol registration, any patient dies from causes judged to be related to his/her external beam radiation treatment

    One year after protocol registration

Secondary Outcomes (5)

  • Evaluate local recurrence rates

    Until patient progressive disease or death

  • Evaluate disease-free survival rates

    Until patient progressive disease or death

  • Evaluate regional recurrence rates

    Until patient progressive disease or death

  • Evaluate distant recurrence rates

    Until patient progressive disease or death

  • Evaluate overall survival rates

    Until patient progressive disease or death

Study Arms (1)

IMRT + Concurrent chemotherapy

EXPERIMENTAL

180 cGy daily fractions to a total dose of 5400 cGy to PTV1 and 200 cGy daily fractions to a total dose of 6000 cGy to PTV2. Once a day, five days a week, for approximately 6 weeks. Planned chemotherapy: cisplatin (75 mg/m2) day 1 and 5-FU (1000 mg/m2) days 1-4 on weeks 1, 5, 10, and 14 of therapy. Please note that drug regimens and doses may vary and will be at the discretion of the medical oncologist.

Radiation: IMRT

Interventions

IMRTRADIATION
IMRT + Concurrent chemotherapy

Eligibility Criteria

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

You may qualify if:

  • Age \>= 18
  • Karnofsky Performance Status of \>= 60
  • TNM Stages T1-4, N0-3, M0
  • Pathologic confirmation of esophagus cancer
  • Evaluation by medical oncologist determines that the patient is medically fit for concurrent chemotherapy
  • Evaluation by surgeon determines that patient is unresectable

You may not qualify if:

  • Age \< 18
  • Karnofsky Performance Status \< 60
  • Radiographic or pathologic evidence of distant metastatic disease (classified as M1b in AJCC staging manual)
  • Prior radiation therapy to the thorax or upper abdomen, preventing definitive radiation therapy.
  • Pregnant or lactating, if female.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jeffrey Bradley, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2008

First Posted

January 15, 2008

Study Start

December 1, 2006

Primary Completion

January 1, 2014

Study Completion

December 1, 2015

Last Updated

April 5, 2016

Record last verified: 2016-04

Locations

US(1)