Predictive Value of 18F-FAZA in Rectum Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Vejle Hospital
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
Vejle Hospital
ClinicalTrials.gov Identifier:
NCT01257035
First received: December 8, 2010
Last updated: May 7, 2012
Last verified: May 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Locally Advanced Rectum Cancer |
Other: 18F-FAZA-PET/CT |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | The Predictive Value of 18F-FAZA-PET/CT in Neoadjuvant Radiation for Patients With Locally Advanced Rectum Cancer |
Resource links provided by NLM:
Further study details as provided by Vejle Hospital:
Primary Outcome Measures:
- Response to chemoradiotherapy measured by TRG [ Time Frame: 8 weeks after chemoradiation treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Recurrence free survival [ Time Frame: From date of inclusion till date of verified recurrence ] [ Designated as safety issue: No ]
- Survival [ Time Frame: From date of inclusion till date of death by any cause ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2010 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 18F-FAZA-PET/CT |
Other: 18F-FAZA-PET/CT
Contrast fluid injected prior to scan
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients with locally advanced rectum cancer receiving preoperative radiation treatment and concomitant chemotherapy at the Dept. of Oncology, Vejle Hospital.
Criteria
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Vejle Hospital |
| ClinicalTrials.gov Identifier: | NCT01257035 History of Changes |
| Other Study ID Numbers: | S-20100054 |
| Study First Received: | December 8, 2010 |
| Last Updated: | May 7, 2012 |
| Health Authority: | Denmark: Ethics Committee |
Keywords provided by Vejle Hospital:
|
Rectum cancer FAZA 18F-FAZA-PET/CT Radiotherapy Chemoradiotherapy |
Additional relevant MeSH terms:
|
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 22, 2013