Status:
TERMINATED
Predictive Value of 18F-FAZA in Rectum Cancer
Lead Sponsor:
Vejle Hospital
Collaborating Sponsors:
Aarhus University Hospital
Conditions:
Locally Advanced Rectum Cancer
Eligibility:
All Genders
18+ years
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01257035
Start Date
November 1 2010
End Date
August 1 2012
Last Update
June 17 2013
Active Locations (1)
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1
Vejle Hospital
Vejle, Denmark