Locally Advanced Rectum Cancer Clinical Trial
— FAZAOfficial title:
The Predictive Value of 18F-FAZA-PET/CT in Neoadjuvant Radiation for Patients With Locally Advanced Rectum Cancer
| Verified date | June 2013 |
| Source | Vejle Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Denmark: Ethics Committee |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 21 |
| Est. completion date | August 2012 |
| Est. primary completion date | February 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Vejle Hospital | Vejle |
| Lead Sponsor | Collaborator |
|---|---|
| Vejle Hospital | Aarhus University Hospital |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Response to chemoradiotherapy measured by TRG | 8 weeks after chemoradiation treatment | No | |
| Secondary | Recurrence free survival | From date of inclusion till date of verified recurrence | No | |
| Secondary | Survival | From date of inclusion till date of death by any cause | No |