Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Predictive Value of 18F-FAZA in Rectum Cancer

This study has been terminated.
(The logistics of this trial (incl. supply of tracer) in connection with the patients' treatment course caused the inclusion rate to be very slow.)
Aarhus University Hospital
Information provided by (Responsible Party):
Vejle Hospital Identifier:
First received: December 8, 2010
Last updated: June 14, 2013
Last verified: June 2013

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.

Condition Intervention
Locally Advanced Rectum Cancer
Other: 18F-FAZA-PET/CT

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Predictive Value of 18F-FAZA-PET/CT in Neoadjuvant Radiation for Patients With Locally Advanced Rectum Cancer

Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • Response to chemoradiotherapy measured by TRG [ Time Frame: 8 weeks after chemoradiation treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recurrence free survival [ Time Frame: From date of inclusion till date of verified recurrence ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: From date of inclusion till date of death by any cause ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: November 2010
Study Completion Date: August 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Contrast fluid injected prior to scan


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.


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.
  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 identifier: NCT01257035

Vejle Hospital
Vejle, Denmark
Sponsors and Collaborators
Vejle Hospital
Aarhus University Hospital
  More Information

No publications provided

Responsible Party: Vejle Hospital Identifier: NCT01257035     History of Changes
Other Study ID Numbers: S-20100054
Study First Received: December 8, 2010
Last Updated: June 14, 2013
Health Authority: Denmark: Ethics Committee

Keywords provided by Vejle Hospital:
Rectum cancer
Chemoradiotherapy processed this record on March 01, 2015