Predictive Value of 18F-FAZA in Rectum Cancer

Vejle Hospital

Status: Terminated

Conditions: Locally Advanced Rectum Cancer

Treatments: Other: 18F-FAZA-PET/CT

Study type: Observational

Funder types: Other

Identifiers

NCT01257035

S-20100054

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

21 participants in 1 patient group

18F-FAZA-PET/CT

Treatment:

Other: 18F-FAZA-PET/CT