PET-CT Based Radiotherapy in Esophageal Cancer Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Maastricht Radiation Oncology.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:
NCT01156831
First received: July 2, 2010
Last updated: February 8, 2011
Last verified: February 2011
  Purpose

The purpose of this study is to determine the locoregional control in PET/CT based radiotherapy treatment planning in the treatment of esophageal cancer patients.


Condition
Esophageal Neoplasms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Consequences of Positron-Emission-Tomography/Computed Tomography (PET/CT) Based Radiotherapy Treatment Planning for Clinical Outcome in Esophageal Cancer Patients

Resource links provided by NLM:


Further study details as provided by Maastricht Radiation Oncology:

Primary Outcome Measures:
  • Locoregional control [ Time Frame: 2 years and 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 2 years and 5 years ] [ Designated as safety issue: No ]
  • Disease Free survival [ Time Frame: 2 years and 5 years ] [ Designated as safety issue: No ]
  • Tumor regression grade [ Time Frame: At the time of surgery ] [ Designated as safety issue: No ]
    Tumor regression grade at time of surgery evaluated by pathologist.


Estimated Enrollment: 100
Study Start Date: November 2004
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Detailed Description:

The purpose of this study is to determine the locoregional control in PET/CT based radiotherapy treatment planning in the treatment of esophageal cancer patients

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary Care Clinic

Criteria

Inclusion Criteria:

  • Histologically proven adenocarcinoma or squamous cell carcinoma of the esophagus
  • Local curable disease able to undergo Chemoradiotherapy.

Exclusion Criteria:

  • Metastasized disease.
  • Previous or concurrent malignancies.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156831

Locations
Netherlands
Atrium Hospital Recruiting
Heerlen, Netherlands
Contact: Meindert Sosef, MD    0031-455566666      
University Medical Center Recruiting
Maastricht, Netherlands
Contact: Kees DeJong, MD    0031-433876543      
St. Laurentius Hospital Recruiting
Roermond, Netherlands
Contact: Jeroen Leijtens, MD    0031-475 382222      
Maasland Hospital Recruiting
Sittard, Netherlands
Contact: Karel Hulsewe, MD    0031-88459 77 77      
St. Jansgasthuis Recruiting
Weert, Netherlands
Contact: deHaan, MD    +31 495 572100      
Sponsors and Collaborators
Maastricht Radiation Oncology
Investigators
Principal Investigator: Guido Lammering, MD PhD Radiation Oncology, Maastro Clinic
Principal Investigator: Meindert Sosef, MD PhD Atrium Hospital Heerlen
  More Information

No publications provided

Responsible Party: I. Steenbakkers, MD / G.Lammering, MD, PhD, MAASTRO clinic
ClinicalTrials.gov Identifier: NCT01156831     History of Changes
Other Study ID Numbers: 09-18-12/08
Study First Received: July 2, 2010
Last Updated: February 8, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht Radiation Oncology:
Esophageal cancer
PET-CT planning

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on September 16, 2014