Locally Advanced Rectum Cancer
Conditions
Keywords
Rectum cancer, FAZA, 18F-FAZA-PET/CT, Radiotherapy, Chemoradiotherapy
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.
Interventions
OTHER18F-FAZA-PET/CT
Contrast fluid injected prior to scan
Sponsors
Aarhus University Hospital
Vejle Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response to chemoradiotherapy measured by TRG | 8 weeks after chemoradiation treatment |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence free survival | From date of inclusion till date of verified recurrence |
| Survival | From date of inclusion till date of death by any cause |
Countries
Denmark
Outcome results
None listed