Predictive Value of 18F-FAZA in Rectum Cancer

NCT ID: NCT01257035

Last Updated: 2013-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-08-31

Brief Summary

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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

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Conditions

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Locally Advanced Rectum Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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18F-FAZA-PET/CT

18F-FAZA-PET/CT

Intervention Type OTHER

Contrast fluid injected prior to scan

Interventions

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18F-FAZA-PET/CT

Contrast fluid injected prior to scan

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

Vejle Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vejle Hospital

Vejle, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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S-20100054

Identifier Type: -

Identifier Source: org_study_id

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