Predictive Value of 18F-FAZA in Rectum Cancer (FAZA)

June 14, 2013 updated by: Vejle Hospital

The Predictive Value of 18F-FAZA-PET/CT in Neoadjuvant Radiation for Patients With Locally Advanced Rectum Cancer

The primary purpose of the study is to investigate 18F-FAZA-PETs role as predictor of response to neoadjuvant chemoradiation of locally advanced rectum cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Vejle, Denmark
        • Vejle Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with locally advanced rectum cancer receiving preoperative radiation treatment and concomitant chemotherapy at the Dept. of Oncology, Vejle Hospital.

Description

Inclusion Criteria:

  • Histopatologically verified adenocarcinoma in the rectum
  • T4 tumor eller T3 tumor < 10 cm from the anus and < 5 mm from the mesorectal fascie measured by MR scan. At the distal part of the rectum the distance to the mesorectal fascie is < 5 mm and therefore all T3 tumors are included in this area
  • Suitable for preoperative radiation and chemotherapy
  • No distant metastases
  • Age >18 years
  • Hematology ANC ≥1.5x10^9/l. Thrombocytes ≥ 100x10^9/l.
  • Biochemistry Bilirubin ≤ 3 x UNL. ALAT ≤ 5 x UNL
  • Creatinine ≤ UNL
  • Contraception for fertile women
  • Written and orally informed consent

Exclusion Criteria:

  • Other malignant disease within 5 years, excl. non-melanotic skin cancer
  • Previous radiation treatment of the pelvis
  • Pregnant or breastfeeding women
  • Surgery within 6 weeks prior to enrollment
  • Serious concurrent medical disease
  • Enrollment in study "A prospective observational study of patients with rectum cancer after concomitant radiation and chemotherapy", where the patients are potientially not operated.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
18F-FAZA-PET/CT
Other: 18F-FAZA-PET/CT
Contrast fluid injected prior to scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response to chemoradiotherapy measured by TRG
Time Frame: 8 weeks after chemoradiation treatment
8 weeks after chemoradiation treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Recurrence free survival
Time Frame: From date of inclusion till date of verified recurrence
From date of inclusion till date of verified recurrence
Survival
Time Frame: From date of inclusion till date of death by any cause
From date of inclusion till date of death by any cause

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vejle Hospital

Collaborators

Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

December 8, 2010

First Submitted That Met QC Criteria

December 8, 2010

First Posted (Estimate)

December 9, 2010

Study Record Updates

Last Update Posted (Estimate)

June 17, 2013

Last Update Submitted That Met QC Criteria

June 14, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-20100054

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Locally Advanced Rectum Cancer

Clinical Trials on 18F-FAZA-PET/CT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe