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

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ClinicalTrials.gov Identifier: NCT01257035
Recruitment Status : 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.)
First Posted : December 9, 2010
Last Update Posted : June 17, 2013
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
Vejle Hospital

Brief Summary:
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 or disease Intervention/treatment
Locally Advanced Rectum Cancer Other: 18F-FAZA-PET/CT

Study Type : Observational
Actual Enrollment : 21 participants
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
Study Start Date : November 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : August 2012

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



Primary Outcome Measures :
  1. Response to chemoradiotherapy measured by TRG [ Time Frame: 8 weeks after chemoradiation treatment ]

Secondary Outcome Measures :
  1. Recurrence free survival [ Time Frame: From date of inclusion till date of verified recurrence ]
  2. Survival [ Time Frame: From date of inclusion till date of death by any cause ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01257035


Locations
Denmark
Vejle Hospital
Vejle, Denmark
Sponsors and Collaborators
Vejle Hospital
Aarhus University Hospital

Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT01257035     History of Changes
Other Study ID Numbers: S-20100054
First Posted: December 9, 2010    Key Record Dates
Last Update Posted: June 17, 2013
Last Verified: June 2013

Keywords provided by Vejle Hospital:
Rectum cancer
FAZA
18F-FAZA-PET/CT
Radiotherapy
Chemoradiotherapy

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases