Predictive Value of 18F-FAZA in Rectum Cancer | NCT01257035

Studies
Predictive Value of 18F-FAZA in Rectum Cancer

NCT01257035

Sponsor

Vejle Hospital

Status

Terminated

Last Update Posted

Jun 17, 2013Estimated

Enrollment

21Actual

Phase

Not provided

Conditions

Locally Advanced Rectum Cancer

Interventions

18F-FAZA-PET/CT

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The logistics of this trial (incl. supply of tracer) in connection with the patients' treatment course caused the inclusion rate to be very slow.

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Feb 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Dec 8, 2010

First Submission Date that Met QC Criteria

Dec 8, 2010

First Posted Date

Dec 9, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2013

Last Update Posted Date

Jun 17, 2013Estimated

Name	Class
Aarhus University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Label	Type	Description	Intervention Names
18F-FAZA-PET/CT			Other: 18F-FAZA-PET/CT

Name	Type	Description	Arm Group Labels	Other Names
18F-FAZA-PET/CT	Other	Contrast fluid injected prior to scan	18F-FAZA-PET/CT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response to chemoradiotherapy measured by TRG		8 weeks after chemoradiation treatment

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with locally advanced rectum cancer receiving preoperative radiation treatment and concomitant chemotherapy at the Dept. of Oncology, Vejle Hospital.

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D012004	Rectal Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided