Predictive Value of 18F-FAZA in Rectum Cancer

Terminated

• Conditions: Locally Advanced Rectum Cancer
• Interventions: Other: 18F-FAZA-PET/CT

• Registration Number: NCT01257035
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-12-08
• Study First Submitted QC: 2010-12-08
• Study First Posted: 2010-12-09
• Primary Completion: 2012-02
• Study Completion: 2012-08
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-14
• Last Update Posted: 2013-06-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
18F-FAZA-PET/CT	18F-FAZA-PET/CT	-

Primary Outcome Measures

Name	Time	Method
Response to chemoradiotherapy measured by TRG	8 weeks after chemoradiation treatment

Secondary Outcome Measures

Name	Time	Method
Recurrence free survival	From date of inclusion till date of verified recurrence
Survival	From date of inclusion till date of death by any cause

Trial Locations

Locations (1)

Vejle Hospital; 🇩🇰 Vejle, Denmark